Tiotropium+Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)
A Randomised, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5 µg / 5 µg; 5 µg / 5 µg) (Delivered by the Respimat® Inhaler) Compared With the Individual Components (2.5 µg and 5 µg Tiotropium, 5 µg Olodaterol) (Delivered by the Respimat® Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD). [TOnado TM 1]
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Buenos Aires, Argentina
- 1237.5.54010 Boehringer Ingelheim Investigational Site
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Caba, Argentina
- 1237.5.54013 Boehringer Ingelheim Investigational Site
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Caba, Argentina
- 1237.5.54016 Boehringer Ingelheim Investigational Site
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Capital Federal, Argentina
- 1237.5.54003 Boehringer Ingelheim Investigational Site
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Cuidad Autonoma de Buenos Airess A, Argentina
- 1237.5.54002 Boehringer Ingelheim Investigational Site
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Mar del Plata, Argentina
- 1237.5.54006 Boehringer Ingelheim Investigational Site
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Mar del Plata, Argentina
- 1237.5.54007 Boehringer Ingelheim Investigational Site
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Mendoza, Argentina
- 1237.5.54009 Boehringer Ingelheim Investigational Site
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Monte Grande, Argentina
- 1237.5.54012 Boehringer Ingelheim Investigational Site
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Quilmes, Argentina
- 1237.5.54008 Boehringer Ingelheim Investigational Site
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Rosario, Argentina
- 1237.5.54005 Boehringer Ingelheim Investigational Site
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San Miguel de Tucuma, Argentina
- 1237.5.54004 Boehringer Ingelheim Investigational Site
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San Miguel de Tucuman, Argentina
- 1237.5.54011 Boehringer Ingelheim Investigational Site
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South Australia
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Toorak Gardens, South Australia, Australia
- 1237.5.61001 Boehringer Ingelheim Investigational Site
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Woodville, South Australia, Australia
- 1237.5.61002 Boehringer Ingelheim Investigational Site
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Victoria
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Frankston, Victoria, Australia
- 1237.5.61004 Boehringer Ingelheim Investigational Site
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Plovdiv, Bulgaria
- 1237.5.35905 Boehringer Ingelheim Investigational Site
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Rousse, Bulgaria
- 1237.5.35901 Boehringer Ingelheim Investigational Site
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Shumen, Bulgaria
- 1237.5.35906 Boehringer Ingelheim Investigational Site
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Sofia, Bulgaria
- 1237.5.35902 Boehringer Ingelheim Investigational Site
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Sofia, Bulgaria
- 1237.5.35904 Boehringer Ingelheim Investigational Site
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Troyan, Bulgaria
- 1237.5.35903 Boehringer Ingelheim Investigational Site
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Veliko Tarnovo, Bulgaria
- 1237.5.35908 Boehringer Ingelheim Investigational Site
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Quebec, Canada
- 1237.5.02003 Boehringer Ingelheim Investigational Site
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Quebec, Canada
- 1237.5.02006 Boehringer Ingelheim Investigational Site
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Alberta
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Calgary, Alberta, Canada
- 1237.5.02002 Boehringer Ingelheim Investigational Site
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British Columbia
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Vancouver, British Columbia, Canada
- 1237.5.02001 Boehringer Ingelheim Investigational Site
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Manitoba
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Winnipeg, Manitoba, Canada
- 1237.5.02004 Boehringer Ingelheim Investigational Site
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Ontario
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Burlington, Ontario, Canada
- 1237.5.02005 Boehringer Ingelheim Investigational Site
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Grimsby, Ontario, Canada
- 1237.5.02007 Boehringer Ingelheim Investigational Site
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Ottawa, Ontario, Canada
- 1237.5.02011 Boehringer Ingelheim Investigational Site
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Quebec
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Sherbrooke, Quebec, Canada
- 1237.5.02008 Boehringer Ingelheim Investigational Site
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Saskatchewan
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Saskatoon, Saskatchewan, Canada
- 1237.5.02009 Boehringer Ingelheim Investigational Site
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Beijing, China
- 1237.5.86003 Boehringer Ingelheim Investigational Site
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Beijing, China
- 1237.5.86004 Boehringer Ingelheim Investigational Site
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Changsha, China
- 1237.5.86011 Boehringer Ingelheim Investigational Site
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Changsha, China
- 1237.5.86012 Boehringer Ingelheim Investigational Site
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Foshan, China
- 1237.5.86014 Boehringer Ingelheim Investigational Site
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Guangzhou, China
- 1237.5.86001 Boehringer Ingelheim Investigational Site
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Nan Ning, China
- 1237.5.86015 Boehringer Ingelheim Investigational Site
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Shanghai, China
- 1237.5.86002 Boehringer Ingelheim Investigational Site
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Shanghai, China
- 1237.5.86005 Boehringer Ingelheim Investigational Site
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Shanghai, China
- 1237.5.86006 Boehringer Ingelheim Investigational Site
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Shanghai, China
- 1237.5.86007 Boehringer Ingelheim Investigational Site
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Shenyang, China
- 1237.5.86009 Boehringer Ingelheim Investigational Site
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Wuhan, China
- 1237.5.86016 Boehringer Ingelheim Investigational Site
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Xi'An, China
- 1237.5.86010 Boehringer Ingelheim Investigational Site
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Yangzhou, China
- 1237.5.86008 Boehringer Ingelheim Investigational Site
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Yinchuan, China
- 1237.5.86017 Boehringer Ingelheim Investigational Site
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Beroun, Czech Republic
- 1237.5.42004 Boehringer Ingelheim Investigational Site
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Cvikov, Czech Republic
- 1237.5.42002 Boehringer Ingelheim Investigational Site
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Praha 6, Czech Republic
- 1237.5.42001 Boehringer Ingelheim Investigational Site
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Rokycany, Czech Republic
- 1237.5.42005 Boehringer Ingelheim Investigational Site
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Znojmo, Czech Republic
- 1237.5.42003 Boehringer Ingelheim Investigational Site
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Aalborg, Denmark
- 1237.5.45002 Boehringer Ingelheim Investigational Site
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Hvidovre, Denmark
- 1237.5.45009 Boehringer Ingelheim Investigational Site
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Kolding, Denmark
- 1237.5.45007 Boehringer Ingelheim Investigational Site
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København NV, Denmark
- 1237.5.45001 Boehringer Ingelheim Investigational Site
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Næstved, Denmark
- 1237.5.45011 Boehringer Ingelheim Investigational Site
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Odense C, Denmark
- 1237.5.45006 Boehringer Ingelheim Investigational Site
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Roskilde, Denmark
- 1237.5.45008 Boehringer Ingelheim Investigational Site
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Silkeborg, Denmark
- 1237.5.45003 Boehringer Ingelheim Investigational Site
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Sønderborg, Denmark
- 1237.5.45005 Boehringer Ingelheim Investigational Site
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Vaerløse, Denmark
- 1237.5.45004 Boehringer Ingelheim Investigational Site
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Tallin, Estonia
- 1237.5.37002 Boehringer Ingelheim Investigational Site
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Tartu, Estonia
- 1237.5.37001 Boehringer Ingelheim Investigational Site
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Helsinki, Finland
- 1237.5.35801 Boehringer Ingelheim Investigational Site
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Pori, Finland
- 1237.5.35804 Boehringer Ingelheim Investigational Site
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Turku, Finland
- 1237.5.35802 Boehringer Ingelheim Investigational Site
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Bethune Cedex, France
- 1237.5.33004 Boehringer Ingelheim Investigational Site
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Montpellier cedex 5, France
- 1237.5.33007 Boehringer Ingelheim Investigational Site
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Nantes, France
- 1237.5.33005 Boehringer Ingelheim Investigational Site
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Nîmes cedex 9, France
- 1237.5.33006 Boehringer Ingelheim Investigational Site
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Perpignan, France
- 1237.5.33008 Boehringer Ingelheim Investigational Site
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Saint Pierre Cedex, France
- 1237.5.33001 Boehringer Ingelheim Investigational Site
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Strasbourg, France
- 1237.5.33002 Boehringer Ingelheim Investigational Site
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Bamberg, Germany
- 1237.5.49006 Boehringer Ingelheim Investigational Site
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Berlin, Germany
- 1237.5.49002 Boehringer Ingelheim Investigational Site
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Berlin, Germany
- 1237.5.49003 Boehringer Ingelheim Investigational Site
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Berlin, Germany
- 1237.5.49013 Boehringer Ingelheim Investigational Site
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Erfurt, Germany
- 1237.5.49011 Boehringer Ingelheim Investigational Site
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Hamburg, Germany
- 1237.5.49005 Boehringer Ingelheim Investigational Site
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Hamburg, Germany
- 1237.5.49010 Boehringer Ingelheim Investigational Site
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Koblenz, Germany
- 1237.5.49009 Boehringer Ingelheim Investigational Site
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Neu-Isenburg, Germany
- 1237.5.49014 Boehringer Ingelheim Investigational Site
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Oschersleben, Germany
- 1237.5.49012 Boehringer Ingelheim Investigational Site
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Rüdersdorf, Germany
- 1237.5.49001 Boehringer Ingelheim Investigational Site
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Weinheim, Germany
- 1237.5.49004 Boehringer Ingelheim Investigational Site
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Wiesloch, Germany
- 1237.5.49008 Boehringer Ingelheim Investigational Site
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Guatemala, Guatemala
- 1237.5.50201 Boehringer Ingelheim Investigational Site
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Guatemala, Guatemala
- 1237.5.50202 Boehringer Ingelheim Investigational Site
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Guatemala, Guatemala
- 1237.5.50203 Boehringer Ingelheim Investigational Site
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Guatemala, Guatemala
- 1237.5.50204 Boehringer Ingelheim Investigational Site
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Guatemala, Guatemala
- 1237.5.50205 Boehringer Ingelheim Investigational Site
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Guatemala, Guatemala
- 1237.5.50206 Boehringer Ingelheim Investigational Site
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Guatemala, Guatemala
- 1237.5.50207 Boehringer Ingelheim Investigational Site
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Debrecen, Hungary
- 1237.5.36005 Boehringer Ingelheim Investigational Site
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Deszk, Hungary
- 1237.5.36001 Boehringer Ingelheim Investigational Site
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Kapuvar, Hungary
- 1237.5.36006 Boehringer Ingelheim Investigational Site
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Szombathely, Hungary
- 1237.5.36003 Boehringer Ingelheim Investigational Site
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Törökbalint, Hungary
- 1237.5.36002 Boehringer Ingelheim Investigational Site
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Ahmedabad, India
- 1237.5.91010 Boehringer Ingelheim Investigational Site
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Bangalore, India
- 1237.5.91002 Boehringer Ingelheim Investigational Site
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Bangalore, India
- 1237.5.91007 Boehringer Ingelheim Investigational Site
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Coimbatore, India
- 1237.5.91004 Boehringer Ingelheim Investigational Site
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Hyderabad, India
- 1237.5.91011 Boehringer Ingelheim Investigational Site
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Jaipur, India
- 1237.5.91001 Boehringer Ingelheim Investigational Site
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Jaipur, India
- 1237.5.91008 Boehringer Ingelheim Investigational Site
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Mysore, India
- 1237.5.91009 Boehringer Ingelheim Investigational Site
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Pune, India
- 1237.5.91006 Boehringer Ingelheim Investigational Site
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Cagliari, Italy
- 1237.5.39008 Boehringer Ingelheim Investigational Site
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Genova, Italy
- 1237.5.39002 Boehringer Ingelheim Investigational Site
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Montescano (PV), Italy
- 1237.5.39006 Boehringer Ingelheim Investigational Site
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Monza, Italy
- 1237.5.39009 Boehringer Ingelheim Investigational Site
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Parma, Italy
- 1237.5.39004 Boehringer Ingelheim Investigational Site
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Pisa, Italy
- 1237.5.39001 Boehringer Ingelheim Investigational Site
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Aoba-ku, Sendai, Miyagi, Japan
- 1237.5.81003 Boehringer Ingelheim Investigational Site
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Asahikawa, Hokkaido, Japan
- 1237.5.81001 Boehringer Ingelheim Investigational Site
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Bunkyo-ku, Tokyo, Japan
- 1237.5.81006 Boehringer Ingelheim Investigational Site
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Chuo-ku, Kumamoto, Kumamoto, Japan
- 1237.5.81044 Boehringer Ingelheim Investigational Site
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Gifu, Gifu, Japan
- 1237.5.81035 Boehringer Ingelheim Investigational Site
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Hakata-ku, Fukuoka, Fukuoka, Japan
- 1237.5.81017 Boehringer Ingelheim Investigational Site
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Hamamatsushi, Shizuoka, Japan
- 1237.5.81031 Boehringer Ingelheim Investigational Site
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Himeji, Hyogo, Japan
- 1237.5.81014 Boehringer Ingelheim Investigational Site
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Ikoma, Nara, Japan
- 1237.5.81037 Boehringer Ingelheim Investigational Site
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Inashiki-gun, Ibaraki, Japan
- 1237.5.81024 Boehringer Ingelheim Investigational Site
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Itabashi-ku, Tokyo, Japan
- 1237.5.81008 Boehringer Ingelheim Investigational Site
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Jonan-ku, Fukuoka, Fukuoka, Japan
- 1237.5.81016 Boehringer Ingelheim Investigational Site
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Kagoshima, Kagoshima, Japan
- 1237.5.81021 Boehringer Ingelheim Investigational Site
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Kagoshima, Kagoshima,, Japan
- 1237.5.81020 Boehringer Ingelheim Investigational Site
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Kamogawa, Chiba, Japan
- 1237.5.81005 Boehringer Ingelheim Investigational Site
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Kishiwada, Osaka, Japan
- 1237.5.81011 Boehringer Ingelheim Investigational Site
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Kitakyusyu,Fukuoka, Japan
- 1237.5.81018 Boehringer Ingelheim Investigational Site
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Koga, Fukuoka, Japan
- 1237.5.81042 Boehringer Ingelheim Investigational Site
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Komaki, Aichi, Japan
- 1237.5.81032 Boehringer Ingelheim Investigational Site
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Komaki, Aichi, Japan
- 1237.5.81033 Boehringer Ingelheim Investigational Site
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Koshi, Kumamoto, Japan
- 1237.5.81019 Boehringer Ingelheim Investigational Site
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Kuki, Saitama, Japan
- 1237.5.81025 Boehringer Ingelheim Investigational Site
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Kure, Hiroshima, Japan
- 1237.5.81038 Boehringer Ingelheim Investigational Site
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Kurume, Fukuoka, Japan
- 1237.5.81015 Boehringer Ingelheim Investigational Site
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Matsumoto, Nagano, Japan
- 1237.5.81029 Boehringer Ingelheim Investigational Site
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Matsumoto, Nagano, Japan
- 1237.5.81030 Boehringer Ingelheim Investigational Site
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Matsusaka, Mie, Japan
- 1237.5.81010 Boehringer Ingelheim Investigational Site
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Minami-ku. Fukuoka, Fukuoka, Japan
- 1237.5.81041 Boehringer Ingelheim Investigational Site
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Morioka, Iwate, Japan
- 1237.5.81002 Boehringer Ingelheim Investigational Site
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Nagoya, Aichi, Japan
- 1237.5.81034 Boehringer Ingelheim Investigational Site
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Nagoya, Aichi, Japan
- 1237.5.81036 Boehringer Ingelheim Investigational Site
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Naka-gun, Ibaraki, Japan
- 1237.5.81004 Boehringer Ingelheim Investigational Site
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Okinawa, Urasoe, Japan
- 1237.5.81022 Boehringer Ingelheim Investigational Site
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Okinawa, Urasoe, Japan
- 1237.5.81023 Boehringer Ingelheim Investigational Site
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Sayama, Osaka, Japan
- 1237.5.81012 Boehringer Ingelheim Investigational Site
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Sendai, Miyagi, Japan
- 1237.5.81045 Boehringer Ingelheim Investigational Site
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Seto, Aichi, Japan
- 1237.5.81009 Boehringer Ingelheim Investigational Site
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Shinagawa, Tokyo, Japan
- 1237.5.81026 Boehringer Ingelheim Investigational Site
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Shinjyuku-ku, Tokyo, Japan
- 1237.5.81007 Boehringer Ingelheim Investigational Site
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Takamatsu, Kagawa, Japan
- 1237.5.81039 Boehringer Ingelheim Investigational Site
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Takamatsu, Kagawa, Japan
- 1237.5.81040 Boehringer Ingelheim Investigational Site
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Wakayama, Wakayama, Japan
- 1237.5.81013 Boehringer Ingelheim Investigational Site
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Yanagawa-shi, Fukuoka,, Japan
- 1237.5.81043 Boehringer Ingelheim Investigational Site
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Yokohama, Kanagawa, Japan
- 1237.5.81028 Boehringer Ingelheim Investigational Site
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koto-ku, Tokyo, Japan
- 1237.5.81027 Boehringer Ingelheim Investigational Site
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Bucheon, Korea, Republic of
- 1237.5.82004 Boehringer Ingelheim Investigational Site
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Daegu, Korea, Republic of
- 1237.5.82008 Boehringer Ingelheim Investigational Site
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Seoul, Korea, Republic of
- 1237.5.82001 Boehringer Ingelheim Investigational Site
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Seoul, Korea, Republic of
- 1237.5.82002 Boehringer Ingelheim Investigational Site
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Seoul, Korea, Republic of
- 1237.5.82003 Boehringer Ingelheim Investigational Site
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Seoul, Korea, Republic of
- 1237.5.82007 Boehringer Ingelheim Investigational Site
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Suwon, Korea, Republic of
- 1237.5.82005 Boehringer Ingelheim Investigational Site
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Wonju, Korea, Republic of
- 1237.5.82006 Boehringer Ingelheim Investigational Site
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Hermosillo, Mexico
- 1237.5.52002 Boehringer Ingelheim Investigational Site
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Mexico, Mexico
- 1237.5.52003 Boehringer Ingelheim Investigational Site
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Monterrey, Mexico
- 1237.5.52007 Boehringer Ingelheim Investigational Site
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Tijuana, Mexico
- 1237.5.52001 Boehringer Ingelheim Investigational Site
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Almelo, Netherlands
- 1237.5.31004 Boehringer Ingelheim Investigational Site
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Breda, Netherlands
- 1237.5.31006 Boehringer Ingelheim Investigational Site
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Eindhoven, Netherlands
- 1237.5.31001 Boehringer Ingelheim Investigational Site
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Harderwijk, Netherlands
- 1237.5.31008 Boehringer Ingelheim Investigational Site
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Heerlen, Netherlands
- 1237.5.31007 Boehringer Ingelheim Investigational Site
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Hengelo, Netherlands
- 1237.5.31010 Boehringer Ingelheim Investigational Site
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Hoorn, Netherlands
- 1237.5.31009 Boehringer Ingelheim Investigational Site
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Nieuwegein, Netherlands
- 1237.5.31005 Boehringer Ingelheim Investigational Site
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Veldhoven, Netherlands
- 1237.5.31002 Boehringer Ingelheim Investigational Site
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Zutphen, Netherlands
- 1237.5.31003 Boehringer Ingelheim Investigational Site
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Dunedin, New Zealand
- 1237.5.64002 Boehringer Ingelheim Investigational Site
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Greenlane East Auckland NZ, New Zealand
- 1237.5.64001 Boehringer Ingelheim Investigational Site
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Amadora, Portugal
- 1237.5.35105 Boehringer Ingelheim Investigational Site
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Coimbra, Portugal
- 1237.5.35101 Boehringer Ingelheim Investigational Site
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Lisboa, Portugal
- 1237.5.35102 Boehringer Ingelheim Investigational Site
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Lisboa, Portugal
- 1237.5.35104 Boehringer Ingelheim Investigational Site
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Porto, Portugal
- 1237.5.35103 Boehringer Ingelheim Investigational Site
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Vila Nova de Gaia, Portugal
- 1237.5.35106 Boehringer Ingelheim Investigational Site
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Viseu, Portugal
- 1237.5.35107 Boehringer Ingelheim Investigational Site
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Gatchina (Leningradskaya oblast), Russian Federation
- 1237.5.07001 Boehringer Ingelheim Investigational Site
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Kazan, Russian Federation
- 1237.5.07003 Boehringer Ingelheim Investigational Site
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Moscow, Russian Federation
- 1237.5.07004 Boehringer Ingelheim Investigational Site
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Moscow, Russian Federation
- 1237.5.07005 Boehringer Ingelheim Investigational Site
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St. Petersburg, Russian Federation
- 1237.5.07002 Boehringer Ingelheim Investigational Site
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Golnik, Slovenia
- 1237.5.38601 Boehringer Ingelheim Investigational Site
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Golnik, Slovenia
- 1237.5.38602 Boehringer Ingelheim Investigational Site
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Istanbul, Turkey
- 1237.5.90003 Boehringer Ingelheim Investigational Site
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Istanbul, Turkey
- 1237.5.90004 Boehringer Ingelheim Investigational Site
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Izmir, Turkey
- 1237.5.90002 Boehringer Ingelheim Investigational Site
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Izmit, Turkey
- 1237.5.90005 Boehringer Ingelheim Investigational Site
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Mersin, Turkey
- 1237.5.90001 Boehringer Ingelheim Investigational Site
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Alabama
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Jasper, Alabama, United States
- 1237.5.01038 Boehringer Ingelheim Investigational Site
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Mobile, Alabama, United States
- 1237.5.01036 Boehringer Ingelheim Investigational Site
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Colorado
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Boulder, Colorado, United States
- 1237.5.01015 Boehringer Ingelheim Investigational Site
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Wheat Ridge, Colorado, United States
- 1237.5.01024 Boehringer Ingelheim Investigational Site
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Connecticut
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Stamford, Connecticut, United States
- 1237.5.01034 Boehringer Ingelheim Investigational Site
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Florida
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Clearwater, Florida, United States
- 1237.5.01003 Boehringer Ingelheim Investigational Site
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Clearwater, Florida, United States
- 1237.5.01010 Boehringer Ingelheim Investigational Site
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Panama City, Florida, United States
- 1237.5.01027 Boehringer Ingelheim Investigational Site
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Illinois
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O'Fallon, Illinois, United States
- 1237.5.01031 Boehringer Ingelheim Investigational Site
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Louisiana
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Opelousas, Louisiana, United States
- 1237.5.01035 Boehringer Ingelheim Investigational Site
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Shreveport, Louisiana, United States
- 1237.5.01004 Boehringer Ingelheim Investigational Site
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Maine
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Biddeford, Maine, United States
- 1237.5.01017 Boehringer Ingelheim Investigational Site
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Maryland
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Columbia, Maryland, United States
- 1237.5.01028 Boehringer Ingelheim Investigational Site
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Michigan
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Livonia, Michigan, United States
- 1237.5.01013 Boehringer Ingelheim Investigational Site
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Nebraska
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Omaha, Nebraska, United States
- 1237.5.01019 Boehringer Ingelheim Investigational Site
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New York
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Larchmont, New York, United States
- 1237.5.01025 Boehringer Ingelheim Investigational Site
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Rochester, New York, United States
- 1237.5.01008 Boehringer Ingelheim Investigational Site
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North Carolina
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Raleigh, North Carolina, United States
- 1237.5.01023 Boehringer Ingelheim Investigational Site
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Tabor City, North Carolina, United States
- 1237.5.01016 Boehringer Ingelheim Investigational Site
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Ohio
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Cincinnati, Ohio, United States
- 1237.5.01006 Boehringer Ingelheim Investigational Site
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Columbus, Ohio, United States
- 1237.5.01040 Boehringer Ingelheim Investigational Site
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Dayton, Ohio, United States
- 1237.5.01039 Boehringer Ingelheim Investigational Site
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Toledo, Ohio, United States
- 1237.5.01037 Boehringer Ingelheim Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, United States
- 1237.5.01009 Boehringer Ingelheim Investigational Site
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Pennsylvania
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Charleston, Pennsylvania, United States
- 1237.5.01032 Boehringer Ingelheim Investigational Site
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Rhode Island
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Johnston, Rhode Island, United States
- 1237.5.01005 Boehringer Ingelheim Investigational Site
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South Carolina
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Easley, South Carolina, United States
- 1237.5.01021 Boehringer Ingelheim Investigational Site
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Gaffney, South Carolina, United States
- 1237.5.01012 Boehringer Ingelheim Investigational Site
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Spartanburg, South Carolina, United States
- 1237.5.01014 Boehringer Ingelheim Investigational Site
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Texas
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Ft. Worth, Texas, United States
- 1237.5.01029 Boehringer Ingelheim Investigational Site
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San Antonio, Texas, United States
- 1237.5.01002 Boehringer Ingelheim Investigational Site
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Virginia
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Lynchburg, Virginia, United States
- 1237.5.01026 Boehringer Ingelheim Investigational Site
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Washington
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Spokane, Washington, United States
- 1237.5.01007 Boehringer Ingelheim Investigational Site
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Tacoma, Washington, United States
- 1237.5.01033 Boehringer Ingelheim Investigational Site
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West Virginia
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Morgantown, West Virginia, United States
- 1237.5.01001 Boehringer Ingelheim Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Diagnosis of chronic obstructive pulmonary disease.
- Relatively stable airway obstruction with post FEV1< 80% predicted normal and post FEV1/FVC <70%.
- Male or female patients, 40 years of age or older.
- Smoking history of more than 10 pack years.
Exclusion criteria:
- Significant disease other than COPD
- Clinically relevant abnormal lab values.
- History of asthma.
- Diagnosis of thyrotoxicosis
- Diagnosis of paroxysmal tachycardia
- History of myocardial infarction within 1 year of screening visit
- Unstable or life-threatening cardiac arrhythmia.
- Hospitalization for heart failure within the past year.
- Known active tuberculosis.
- Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
- History of life-threatening pulmonary obstruction.
- History of cystic fibrosis.
- Clinically evident bronchiectasis.
- History of significant alcohol or drug abuse.
- Thoracotomy with pulmonary resection
- Oral ß-adrenergics.
- Oral corticosteroid medication at unstable doses
- Regular use of daytime oxygen therapy for more than one hour per day
- Pulmonary rehabilitation program in the six weeks prior to the screening visit
- Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
- Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA
- Pregnant or nursing women.
- Women of childbearing potential not using a highly effective method of birth control
- Patients who are unable to comply with pulmonary medication restrictions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: tiotropium+olodaterol low dose FDC
Once daily 2 puffs solution for inhalation Respimat
|
Respimat inhaler
fixed dose combination
|
|
Experimental: tiotropium+olodaterol high dose FDC
Once daily 2 puffs solution for inhalation Respimat
|
Respimat inhaler
fixed dose combination
|
|
Active Comparator: olodaterol
Once daily 2 puffs solution for inhalation Respimat
|
Respimat inhaler
one dose only
|
|
Active Comparator: tiotropium low dose
Once daily 2 puffs solution for inhalation Respimat
|
Respimat inhaler
low dose
high dose
|
|
Active Comparator: tiotropium high dose
Once daily 2 puffs solution for inhalation Respimat
|
Respimat inhaler
low dose
high dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3h) Response on Day 169.
Time Frame: 1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169.
|
FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1). The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom. Number of participants analyzed are the number of patients contributing to the MMRM model in each treatment group. |
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169.
|
|
Trough FEV1 Response on Day 170.
Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170
|
Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours) and was calculated as the mean of the 2 FEV1 measurements performed at 23 h and at 23 h 50 min after inhalation of study medication at the clinic visit on the previous day. Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1). The adjusted means (SE) were obtained from fitting an MMRM including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group. |
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170
|
|
Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)
Time Frame: Day 169
|
The SGRQ is designed to measure health impairment in patients with COPD.
It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores.
A total score is also produced.
Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition.
The total score uses the same calculation except that the weights are summed over the entire questionnaire.
The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.
|
Day 169
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)
Time Frame: Day 169
|
Mahler Transitional Dyspnoea Index (TDI) focal score on Day 169 From the Two Twin Trials, present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) is the key secondary endpoint. The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group. |
Day 169
|
|
FEV1 AUC(0-3h) Response on Day 1
Time Frame: 1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment.
|
FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1. The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group. |
1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment.
|
|
FEV1 AUC(0-3h) Response on Day 85
Time Frame: 1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85.
|
FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1. The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group. |
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85.
|
|
FEV1 AUC(0-3h) Response on Day 365
Time Frame: 1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365.
|
FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1. The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group. |
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365.
|
|
Trough FEV1 Response on Day 15.
Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15
|
Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements. Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group. |
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15
|
|
Trough FEV1 Response on Day 43
Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43.
|
Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements. Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group. |
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43.
|
|
Trough FEV1 Response on Day 85
Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on day 85.
|
Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements. Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group. |
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on day 85.
|
|
Trough FEV1 Response on Day 169
Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on Day 169
|
Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements. Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group. |
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on Day 169
|
|
Trough FEV1 Response on Day 365
Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on day 365
|
Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements. Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group. |
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on day 365
|
|
FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 1
Time Frame: 1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment.
|
FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1). The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group. |
1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment.
|
|
FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 85
Time Frame: 1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85.
|
FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC.Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1). The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group. |
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85.
|
|
FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 169
Time Frame: 1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169.
|
FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1). The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group. |
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169.
|
|
FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 365
Time Frame: 1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365.
|
FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1). The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group. |
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365.
|
|
Trough FVC Response on Day 15.
Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15
|
Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements. Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1). Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group. The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom. |
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15
|
|
Trough FVC Response on Day 43.
Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43
|
Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements. Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1). Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group. The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom. |
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43
|
|
Trough FVC Response on Day 85.
Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on day 85
|
Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements. Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1). Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group. The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom. |
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on day 85
|
|
Trough FVC Response on Day 170.
Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170
|
Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours) and was calculated as the mean of the 2 FVC measurements performed at 23h and at 23h 50 min after inhalation of study medication at the clinic visit on the previous day. Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1). The adjusted means (SE) were obtained from fitting an MMRM including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group. |
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170
|
|
Trough FVC Response on Day 365.
Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on Day 365.
|
Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements. Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1). Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group. The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom. |
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on Day 365.
|
|
FEV1 AUC(0-12h) Response in the Sub-set of Patients With 12-hour Pulmonary Function Test (PFT) on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)
Time Frame: 1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169.
|
FEV1 AUC(0-12h) was calculated as the area under the FEV1- time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres. FEV1 AUC(0-12h) response was defined as FEV1 AUC(0-12h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1). The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate. Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group. |
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169.
|
|
FEV1 AUC(0-24h) Response in the Sub-set of Patients With 12-h PFTs on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)
Time Frame: 1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169.
|
FEV1 AUC(0-24h) was calculated as the area under the FEV1- time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres. FEV1 AUC(0-24h) response was defined as FEV1 AUC(0-24h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1). The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate. Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group. |
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169.
|
|
FVC AUC(0-12h) Response in the Sub-set of Patients With 12-h PFTs on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)
Time Frame: 1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169.
|
FVC AUC(0-12h) was calculated as the area under the FVC- time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres. FVC AUC(0-12h) response was defined as FVC AUC(0-12h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1). The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate. Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group. |
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169.
|
|
FVC AUC(0-24h) Response in Sub-set of Patients With 24-h PFTs on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)
Time Frame: 1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169.
|
FVC AUC(0-24h) was calculated as the area under the FVC- time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres. FVC AUC(0-24h) response was defined as FVC AUC(0-24h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1). The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate. Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group. |
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169.
|
|
Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 85 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)
Time Frame: Day 85
|
The SGRQ is designed to measure health impairment in patients with COPD.
It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores.
A total score is also produced.
Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition.
The total score uses the same calculation except that the weights are summed over the entire questionnaire.
The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.
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Day 85
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Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 365 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)
Time Frame: Day 365
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The SGRQ is designed to measure health impairment in patients with COPD.
It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores.
A total score is also produced.
Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition.
The total score uses the same calculation except that the weights are summed over the entire questionnaire.
The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.
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Day 365
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Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 43 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)
Time Frame: Day 43
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Mahler Transitional Dyspnoea Index (TDI) focal score on Day 43 From the Two Twin Trials, present 1237.5 (NCT01431274) and 1237.6 (NCT01431287). The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group. |
Day 43
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Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 85 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)
Time Frame: Day 85
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Mahler Transitional Dyspnoea Index (TDI) focal score on Day 85 From the Two Twin Trials, present 1237.5 (NCT01431274) and 1237.6 (NCT01431287). The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group. |
Day 85
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Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 365 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)
Time Frame: Day 365
|
Mahler Transitional Dyspnoea Index (TDI) focal score on Day 365 From the Two Twin Trials, present 1237.5 (NCT01431274) and 1237.6 (NCT01431287). The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group. |
Day 365
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.
- Buhl R, de la Hoz A, Xue W, Singh D, Ferguson GT. Efficacy of Tiotropium/Olodaterol Compared with Tiotropium as a First-Line Maintenance Treatment in Patients with COPD Who Are Naive to LAMA, LABA and ICS: Pooled Analysis of Four Clinical Trials. Adv Ther. 2020 Oct;37(10):4175-4189. doi: 10.1007/s12325-020-01411-0. Epub 2020 Jul 15.
- Buhl R, Singh D, de la Hoz A, Xue W, Ferguson GT. Benefits of Tiotropium/Olodaterol Compared with Tiotropium in Patients with COPD Receiving only LAMA at Baseline: Pooled Analysis of the TONADO(R) and OTEMTO(R) Studies. Adv Ther. 2020 Aug;37(8):3485-3499. doi: 10.1007/s12325-020-01373-3. Epub 2020 May 27.
- Rabe KF, Chalmers JD, Miravitlles M, Kocks JWH, Tsiligianni I, de la Hoz A, Xue W, Singh D, Ferguson GT, Wedzicha J. Tiotropium/Olodaterol Delays Clinically Important Deterioration Compared with Tiotropium Monotherapy in Patients with Early COPD: a Post Hoc Analysis of the TONADO(R) Trials. Adv Ther. 2021 Jan;38(1):579-593. doi: 10.1007/s12325-020-01528-2. Epub 2020 Nov 11.
- Andreas S, Bothner U, de la Hoz A, Kloer I, Trampisch M, Alter P. No Influence on Cardiac Arrhythmia or Heart Rate from Long-Term Treatment with Tiotropium/Olodaterol versus Monocomponents by Holter ECG Analysis in Patients with Moderate-to-Very-Severe COPD. Int J Chron Obstruct Pulmon Dis. 2020 Aug 10;15:1945-1953. doi: 10.2147/COPD.S246350. eCollection 2020.
- Andreas S, McGarvey L, Bothner U, Trampisch M, de la Hoz A, Flezar M, Buhl R, Alter P. Absence of Adverse Effects of Tiotropium/Olodaterol Compared with the Monocomponents on Long-Term Heart Rate and Blood Pressure in Patients with Moderate-to-Very-Severe COPD. Int J Chron Obstruct Pulmon Dis. 2020 Aug 10;15:1935-1944. doi: 10.2147/COPD.S246348. eCollection 2020.
- Wedzicha JA, Buhl R, Singh D, Vogelmeier CF, de la Hoz A, Xue W, Anzueto A, Calverley PMA. Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO(R)/DYNAGITO(R) Trials. Adv Ther. 2020 Oct;37(10):4266-4279. doi: 10.1007/s12325-020-01438-3. Epub 2020 Aug 10.
- Ferguson GT, Buhl R, Bothner U, Hoz A, Voss F, Anzueto A, Calverley PMA. Safety of tiotropium/olodaterol in chronic obstructive pulmonary disease: pooled analysis of three large, 52-week, randomized clinical trials. Respir Med. 2018 Oct;143:67-73. doi: 10.1016/j.rmed.2018.08.012. Epub 2018 Aug 28.
- Maltais F, Buhl R, Koch A, Amatto VC, Reid J, Gronke L, Bothner U, Voss F, McGarvey L, Ferguson GT. beta-Blockers in COPD: A Cohort Study From the TONADO Research Program. Chest. 2018 Jun;153(6):1315-1325. doi: 10.1016/j.chest.2018.01.008. Epub 2018 Jan 31.
- Buhl R, Magder S, Bothner U, Tetzlaff K, Voss F, Loaiza L, Vogelmeier CF, McGarvey L. Long-term general and cardiovascular safety of tiotropium/olodaterol in patients with moderate to very severe chronic obstructive pulmonary disease. Respir Med. 2017 Jan;122:58-66. doi: 10.1016/j.rmed.2016.11.011. Epub 2016 Nov 14.
- Ferguson GT, Flezar M, Korn S, Korducki L, Gronke L, Abrahams R, Buhl R. Efficacy of Tiotropium + Olodaterol in Patients with Chronic Obstructive Pulmonary Disease by Initial Disease Severity and Treatment Intensity: A Post Hoc Analysis. Adv Ther. 2015 Jun;32(6):523-36. doi: 10.1007/s12325-015-0218-0. Epub 2015 Jun 26.
- Buhl R, Maltais F, Abrahams R, Bjermer L, Derom E, Ferguson G, Flezar M, Hebert J, McGarvey L, Pizzichini E, Reid J, Veale A, Gronke L, Hamilton A, Korducki L, Tetzlaff K, Waitere-Wijker S, Watz H, Bateman E. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2-4). Eur Respir J. 2015 Apr;45(4):969-79. doi: 10.1183/09031936.00136014. Epub 2015 Jan 8. Erratum In: Eur Respir J. 2015 Jun;45(6):1763.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Tiotropium Bromide
- Olodaterol
Other Study ID Numbers
- 1237.5
- 2009-010668-40 (EudraCT Number: EudraCT)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.