Tiotropium / Respimat One Year Study in COPD.

May 7, 2014 updated by: Boehringer Ingelheim

Efficacy {FEV1, COPD Exacerbations & HRQoL} & Safety of 5mcg Tiotropium Respimat in COPD

The objective of the study is to evaluate the long-term (one year) efficacy and safety of tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study will examine the effect of treatment on COPD exacerbations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3991

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Glebe, New South Wales, Australia
        • 205.372.61002 Woolcock Institute of Medical Research
    • Queensland
      • Cairns, Queensland, Australia
        • 205.372.61009 Thoracic & General Physician
      • Redcliffe, Queensland, Australia
        • 205.372.61005 Redcliffe Hospital
    • South Australia
      • Port Lincoln, South Australia, Australia
        • 205.372.61006 The Investigator Clinic
      • Toorak Gardens, South Australia, Australia
        • 205.372.61007 The Burnside War Memorial Hospital
      • Woodville, South Australia, Australia
        • 205.372.61004 Boehringer Ingelheim Investigational Site
    • Victoria
      • Box Hill, Victoria, Australia
        • 205.372.61010 Ecru
      • Geelong, Victoria, Australia
        • 205.372.61008 Geelong Clinical Research Centre
      • Malvern, Victoria, Australia
        • 205.372.61001 Emeritus Research
    • Western Australia
      • Nedlands, Western Australia, Australia
        • 205.372.61003 Sir Charles Gairdner Hospital
  • Brazil
      • Florianópolis, Brazil
        • 205.372.55012 Universidade Federal de Santa Catarina
      • Goiânia, Brazil
        • 205.372.55009 Hospital das Clínicas de Goiânia
      • Recife, Brazil
        • 205.372.55005 Hospital Geral Otávio de Freitas
      • São Paulo - SP, Brazil
        • 205.372.55001 INCOR e Hospital das Clínicas da Universidade de São Paulo
      • São Paulo - SP, Brazil
        • 205.372.55010 Unidade de Coracao e Pulmao do Dto. de Medicina
      • Vitória, Brazil
        • 205.372.55011 CEDOES - Diagnóstico e Pesquisa
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • 205.372.11007 Heritage Medical Research Building
      • Calgary, Alberta, Canada
        • 205.372.11013 Calgary West Medical Centre
      • Edmonton, Alberta, Canada
        • 205.372.11011 Hermitage Medicentre
      • Edmonton, Alberta, Canada
        • 205.372.11017 Boehringer Ingelheim Investigational Site
      • Wetaskiwin, Alberta, Canada
        • 205.372.11020 Wetaskiwin Lung Laboratory
    • British Columbia
      • Chilliwack, British Columbia, Canada
        • 205.372.11010 Dr. Kay Ho
      • Vancouver, British Columbia, Canada
        • 205.372.11018 Pacific Lung Health Centre
    • New Brunswick
      • Saint John, New Brunswick, Canada
        • 205.372.11005 Professional Corp. Respirology
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • 205.372.11009 White Hills Medical Clinic
    • Ontario
      • Grimsby, Ontario, Canada
        • 205.372.11012 West Lincoln Memorial Hospital
      • London, Ontario, Canada
        • 205.372.11014 Dr. Robert Luton
      • Niagara Falls, Ontario, Canada
        • 205.372.11001 Niagara Clinical Research
      • Ottawa, Ontario, Canada
        • 205.372.11019 Allergy and Asthma Research Centre
      • Sarnia, Ontario, Canada
        • 205.372.11003 London Road Diagnostic Clinic and Medical Centre
      • Sarnia, Ontario, Canada
        • 205.372.11016 London Road Diagnostic Clinic and Medical Centre
      • Scarborough, Ontario, Canada
        • 205.372.11002 Centenary Respiratory Research Associates
    • Quebec
      • La Malbaie, Quebec, Canada
        • 205.372.11006 Clinique de médecine familiale de La Malbaie
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • 205.372.11004 Mount Royal Family Physicians
      • Saskatoon, Saskatchewan, Canada
        • 205.372.11015 Dr. Arun Nayar
  • China
      • Beijing, China
        • 205.372.86002 Boehringer Ingelheim Investigational Site
      • Beijing, China
        • 205.372.86003 Boehringer Ingelheim Investigational Site
      • Beijing, China
        • 205.372.86004 Boehringer Ingelheim Investigational Site
      • Chengdu, Sichuan Province, China
        • 205.372.86009 Boehringer Ingelheim Investigational Site
      • Chongqing, China
        • 205.372.86008 Boehringer Ingelheim Investigational Site
      • Guangzhou, China
        • 205.372.86001 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 205.372.86010 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 205.372.86011 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 205.372.86012 Boehringer Ingelheim Investigational Site
      • Shenyang, China
        • 205.372.86005 Boehringer Ingelheim Investigational Site
      • Shenyang, China
        • 205.372.86006 Boehringer Ingelheim Investigational Site
      • Wuhan, China
        • 205.372.86007 Boehringer Ingelheim Investigational Site
  • Denmark
      • Aarhus C, Denmark
        • 205.372.45004 Boehringer Ingelheim Investigational Site
      • Horsens, Denmark
        • 205.372.45005 Boehringer Ingelheim Investigational Site
      • Hvidovre, Denmark
        • 205.372.45002 Boehringer Ingelheim Investigational Site
      • København NV, Denmark
        • 205.372.45001 Boehringer Ingelheim Investigational Site
      • Odense C, Denmark
        • 205.372.45003 Boehringer Ingelheim Investigational Site
      • Silkeborg, Denmark
        • 205.372.45006 Boehringer Ingelheim Investigational Site
  • Finland
      • Helsinki, Finland
        • 205.372.35804 Boehringer Ingelheim Investigational Site
      • Jyväskylä, Finland
        • 205.372.35802 Boehringer Ingelheim Investigational Site
      • Lahti, Finland
        • 205.372.35803 Boehringer Ingelheim Investigational Site
      • Tampere, Finland
        • 205.372.35801 Boehringer Ingelheim Investigational Site
  • France
      • Castelnau le Lez, France
        • 205.372.3318A Clinique du Parc
      • Castelnau le Lez, France
        • 205.372.3318B Clinique du Parc
      • Chamalières, France
        • 205.372.3304A Cabinet Médical
      • Clermont Ferrand cedex 1, France
        • 205.372.3301A Hôpital Gabriel Montpied
      • Denain, France
        • 205.372.3310A Centre Hospitalier
      • Grasse, France
        • 205.372.3314A Cabinet Médical
      • Marseille, France
        • 205.372.3306A Hôpital Ambroise Paré
      • Metz cedex 1, France
        • 205.372.3303A Hôpital Notre Dame de Bon Secours
      • Metz cedex 1, France
        • 205.372.3303B Hôpital Notre Dame de Bon Secours
      • Montigny les Metz, France
        • 205.372.3312A Cabinet Médical
      • Montigny les Metz, France
        • 205.372.3312B Cabinet Médical
      • Nantes, France
        • 205.372.3302A Centre Médical Erdre Saint Augustin
      • Nice, France
        • 205.372.3305A Cabinet Médical
      • Nice, France
        • 205.372.3305B Cabinet Médical
      • Nimes cedex 9, France
        • 205.372.3315B Hôpital Caremeau
      • Nîmes, France
        • 205.372.3315A Hôpital Caremeau
      • Nîmes, France
        • 205.372.3317A Cabinet de Pneumologie
      • Ollioules, France
        • 205.372.3320A Polyclinique Les Fleurs
      • Ollioules, France
        • 205.372.3320B Polyclinique Les Fleurs
      • Reims, France
        • 205.372.3316A Clinique les Bleuets
      • Reims, France
        • 205.372.3316B Clinique les Bleuets
      • Saint Laurent du Var, France
        • 205.372.3319A Institut Arnault Tzanck
      • Six Four les Plages, France
        • 205.372.3325A Cabinet Médical
      • St Gaudens, France
        • 205.372.3321A Centre Hospitalier
      • St Gaudens, France
        • 205.372.3321C Centre Hospitalier
      • Toulon, France
        • 205.372.3324A Cabinet Médical
      • Toulouse, France
        • 205.372.3309A Cabinet médical
      • Toulouse, France
        • 205.372.3309B Cabinet médical
  • Germany
      • Berlin, Germany
        • 205.372.49002 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 205.372.49004 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 205.372.49013 Boehringer Ingelheim Investigational Site
      • Bonn, Germany
        • 205.372.49007 Boehringer Ingelheim Investigational Site
      • Bruchsal, Germany
        • 205.372.49008 Boehringer Ingelheim Investigational Site
      • Frankfurt/Main, Germany
        • 205.372.49011 Boehringer Ingelheim Investigational Site
      • Gelnhausen, Germany
        • 205.372.49012 Boehringer Ingelheim Investigational Site
      • Gütersloh, Germany
        • 205.372.49006 Boehringer Ingelheim Investigational Site
      • Hannover, Germany
        • 205.372.49014 Boehringer Ingelheim Investigational Site
      • Kassel, Germany
        • 205.372.49005 Boehringer Ingelheim Investigational Site
      • Minden, Germany
        • 205.372.49009 Boehringer Ingelheim Investigational Site
      • München, Germany
        • 205.372.49010 Boehringer Ingelheim Investigational Site
      • Weinheim, Germany
        • 205.372.49016 Boehringer Ingelheim Investigational Site
      • Weyhe, Germany
        • 205.372.49015 Boehringer Ingelheim Investigational Site
      • Wiesloch, Germany
        • 205.372.49001 Boehringer Ingelheim Investigational Site
      • Witten, Germany
        • 205.372.49003 Boehringer Ingelheim Investigational Site
  • Greece
      • Athens, Greece
        • 205.372.30001 Boehringer Ingelheim Investigational Site
      • Athens, Greece
        • 205.372.30002 Boehringer Ingelheim Investigational Site
      • Athens, Greece
        • 205.372.30003 Boehringer Ingelheim Investigational Site
      • Athens, Greece
        • 205.372.30013 Boehringer Ingelheim Investigational Site
      • Athens, Greece
        • 205.372.30015 Boehringer Ingelheim Investigational Site
      • Heraklion-Crete, Greece
        • 205.372.30009 Boehringer Ingelheim Investigational Site
      • Kalamaria, Greece
        • 205.372.30007 Boehringer Ingelheim Investigational Site
      • Kavala, Greece
        • 205.372.30005 Boehringer Ingelheim Investigational Site
      • Komotini, Greece
        • 205.372.30004 Boehringer Ingelheim Investigational Site
      • Korinthos, Greece
        • 205.372.30011 Boehringer Ingelheim Investigational Site
      • Nafplio, Greece
        • 205.372.30019 Boehringer Ingelheim Investigational Site
      • Serres, Greece
        • 205.372.30008 Boehringer Ingelheim Investigational Site
      • Thessaloniki, Greece
        • 205.372.30006 Boehringer Ingelheim Investigational Site
      • Thessaloniki, Greece
        • 205.372.30017 Boehringer Ingelheim Investigational Site
      • Thiva, Greece
        • 205.372.30014 Boehringer Ingelheim Investigational Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • 205.372.85203 Boehringer Ingelheim Investigational Site
      • Kowloon, Hong Kong
        • 205.372.85201 Boehringer Ingelheim Investigational Site
  • Hungary
      • Budapest, Hungary
        • 205.372.36001 Boehringer Ingelheim Investigational Site
      • Debrecen, Hungary
        • 205.372.36002 Boehringer Ingelheim Investigational Site
      • Deszk, Hungary
        • 205.372.36004 Boehringer Ingelheim Investigational Site
      • Erd, Hungary
        • 205.372.36005 Boehringer Ingelheim Investigational Site
      • Mosonmagyarovar, Hungary
        • 205.372.36006 Boehringer Ingelheim Investigational Site
      • Sopron, Hungary
        • 205.372.36007 Boehringer Ingelheim Investigational Site
  • India
      • Andhra Pradesh, India
        • 205.372.91005 Boehringer Ingelheim Investigational Site
      • Andhra Pradesh, India
        • 205.372.91016 Boehringer Ingelheim Investigational Site
      • Bangalore, India
        • 205.372.91003 Boehringer Ingelheim Investigational Site
      • Bangalore, India
        • 205.372.91006 Boehringer Ingelheim Investigational Site
      • Calicut,Kerala, India
        • 205.372.91017 Boehringer Ingelheim Investigational Site
      • Chennai, India
        • 205.372.91007 Boehringer Ingelheim Investigational Site
      • Chennai, India
        • 205.372.91010 Boehringer Ingelheim Investigational Site
      • Coimbatore, India
        • 205.372.91002 Boehringer Ingelheim Investigational Site
      • Gujarat, India
        • 205.372.91009 Boehringer Ingelheim Investigational Site
      • Maharashtra, India
        • 205.372.91012 Boehringer Ingelheim Investigational Site
      • Mumbai, India
        • 205.372.91004 Boehringer Ingelheim Investigational Site
      • Mumbai, India
        • 205.372.91008 Boehringer Ingelheim Investigational Site
      • New Delhi, India
        • 205.372.91015 Boehringer Ingelheim Investigational Site
      • Punjab, India
        • 205.372.91014 Boehringer Ingelheim Investigational Site
      • Tamil Nadu, India
        • 205.372.91013 Boehringer Ingelheim Investigational Site
      • Uttar Pradesh, India
        • 205.372.91001 Boehringer Ingelheim Investigational Site
      • indore,MP, India
        • 205.372.91011 Boehringer Ingelheim Investigational Site
  • Ireland
      • Mullingar, Ireland
        • 205.372.35303 Boehringer Ingelheim Investigational Site
  • Italy
      • Bussolengo (vr), Italy
        • 205.372.39007 Boehringer Ingelheim Investigational Site
      • Ferrara, Italy
        • 205.372.39012 Boehringer Ingelheim Investigational Site
      • Genova, Italy
        • 205.372.39003 Boehringer Ingelheim Investigational Site
      • Genova, Italy
        • 205.372.39004 Boehringer Ingelheim Investigational Site
      • Milano, Italy
        • 205.372.39005 Boehringer Ingelheim Investigational Site
      • Modena, Italy
        • 205.372.39008 Boehringer Ingelheim Investigational Site
      • Orbassano (to), Italy
        • 205.372.39009 Boehringer Ingelheim Investigational Site
      • Pisa, Italy
        • 205.372.39001 Boehringer Ingelheim Investigational Site
      • Pordenone, Italy
        • 205.372.39010 Boehringer Ingelheim Investigational Site
      • Prato (fi), Italy
        • 205.372.39002 Boehringer Ingelheim Investigational Site
      • Roma, Italy
        • 205.372.39011 Boehringer Ingelheim Investigational Site
      • Trieste, Italy
        • 205.372.39006 Boehringer Ingelheim Investigational Site
  • Korea, Republic of
      • Anyang, Korea, Republic of
        • 205.372.82010 Boehringer Ingelheim Investigational Site
      • Daegu, Korea, Republic of
        • 205.372.82005 Boehringer Ingelheim Investigational Site
      • Daejoen, Korea, Republic of
        • 205.372.82009 Boehringer Ingelheim Investigational Site
      • Incheon, Korea, Republic of
        • 205.372.82003 Boehringer Ingelheim Investigational Site
      • Jeonbuk, Korea, Republic of
        • 205.372.82008 Boehringer Ingelheim Investigational Site
      • Kwangju, Korea, Republic of
        • 205.372.82007 Boehringer Ingelheim Investigational Site
      • Pusan, Korea, Republic of
        • 205.372.82002 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 205.372.82001 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 205.372.82004 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 205.372.82006 Boehringer Ingelheim Investigational Site
  • Lithuania
      • Kaunas, Lithuania
        • 205.372.37001 Boehringer Ingelheim Investigational Site
      • Kaunas, Lithuania
        • 205.372.37003 Boehringer Ingelheim Investigational Site
      • Vilnius, Lithuania
        • 205.372.37002 Boehringer Ingelheim Investigational Site
  • Malaysia
      • Johor Baharu, Malaysia
        • 205.372.60007 Boehringer Ingelheim Investigational Site
      • Kelantan Darul Naim, Malaysia
        • 205.372.60004 Boehringer Ingelheim Investigational Site
      • Kuala Lumpur, Malaysia
        • 205.372.60005 Boehringer Ingelheim Investigational Site
      • Kuala Lumpur, Malaysia
        • 205.372.60006 Boehringer Ingelheim Investigational Site
      • Kuching, Sarawak, Malaysia
        • 205.372.60002 Boehringer Ingelheim Investigational Site
      • Penang, Malaysia
        • 205.372.60003 Boehringer Ingelheim Investigational Site
      • Selangor, Malaysia
        • 205.372.60001 Boehringer Ingelheim Investigational Site
  • Mexico
      • Chihuahua, Mexico
        • 205.372.52018 Hospital Universitario de Chihuahua
      • Col. Seccion XVI, Mexico
        • 205.372.52017 Instituto Nacional de Enfermedades Respiratorias (INER)
      • Cuernavaca, Mor. México, Mexico
        • 205.372.52013 Sanatorio Henri Dunant
      • Guadalajara, Mexico
        • 205.372.52005 Hospital Civil Nuevo de Guadalajara
      • Guadalajara Jal., Mexico
        • 205.372.52009 Hospital Civil Antiguo
      • Hermosillo, Sonora, Mexico
        • 205.372.52001 Hospital General del Estado de Sonora
      • Huixquilucan Edo.Mex., Mexico
        • 205.372.52014 Hospital Angeles de las Lomas
      • Merida Yuc., Mexico
        • 205.372.52004 Clínica de Mérida
      • Mexicali Baja California Norte, Mexico
        • 205.372.52016 Hospital General de Mexicali
      • Monterrey, Nuevo León, Mexico
        • 205.372.52002 Unidad de Investigación clínica en Medicina
      • Monterrey, Nuevo León, Mexico
        • 205.372.52006 Hospital Universitario
      • Mérida Yucatán, Mexico
        • 205.372.52010 Hospital General Agustin O´Haran
      • San Luis Potosi, Mexico
        • 205.372.52012 Hospital de Nuestra Señora de la Salud
      • Zapopan, Jal., Mexico
        • 205.372.52003 Hospital "Angel Leaño"
  • Netherlands
      • Amsterdam, Netherlands
        • 205.372.31009 Boehringer Ingelheim Investigational Site
      • Drachten, Netherlands
        • 205.372.31006 Boehringer Ingelheim Investigational Site
      • Groningen, Netherlands
        • 205.372.31001 Boehringer Ingelheim Investigational Site
      • Hoofddorp, Netherlands
        • 205.372.31011 Boehringer Ingelheim Investigational Site
      • Leeuwarden, Netherlands
        • 205.372.31007 Boehringer Ingelheim Investigational Site
      • Roosendaal, Netherlands
        • 205.372.31004 Boehringer Ingelheim Investigational Site
      • Sneek, Netherlands
        • 205.372.31003 Boehringer Ingelheim Investigational Site
      • Utrecht, Netherlands
        • 205.372.31012 Boehringer Ingelheim Investigational Site
      • Voorburg, Netherlands
        • 205.372.31002 Boehringer Ingelheim Investigational Site
      • Weerselo, Netherlands
        • 205.372.31008 Boehringer Ingelheim Investigational Site
      • Winschoten, Netherlands
        • 205.372.31005 Boehringer Ingelheim Investigational Site
  • Norway
      • Sandvika, Norway
        • 205.372.47001 Boehringer Ingelheim Investigational Site
      • Trondheim, Norway
        • 205.372.47003 Boehringer Ingelheim Investigational Site
      • Ålesund, Norway
        • 205.372.47002 Boehringer Ingelheim Investigational Site
  • Portugal
      • Amadora, Portugal
        • 205.372.35102 Hospital Fernando Fonseca
      • Lisboa, Portugal
        • 205.372.35101 Hospital Pulido Valente
      • Lisboa, Portugal
        • 205.372.35104 Hospital de Santa Marta
      • Porto, Portugal
        • 205.372.35103 Hospital de São João
      • Viana do Castelo, Portugal
        • 205.372.35105 Centro Hospitalar do Alto Minho, Estrada de Santa Luzia
  • Singapore
      • Singapore, Singapore
        • 205.372.65001 Boehringer Ingelheim Investigational Site
      • Singapore, Singapore
        • 205.372.65003 Boehringer Ingelheim Investigational Site
      • Singapore, Singapore
        • 205.372.65005 Boehringer Ingelheim Investigational Site
  • Slovakia
      • Bratislava, Slovakia
        • 205.372.42102 Boehringer Ingelheim Investigational Site
      • Nove Zamky, Slovakia
        • 205.372.42103 Boehringer Ingelheim Investigational Site
  • South Africa
      • Bellville, South Africa
        • 205.372.27002 Boehringer Ingelheim Investigational Site
      • Cape Town, South Africa
        • 205.372.27001 Boehringer Ingelheim Investigational Site
      • Cape Town, South Africa
        • 205.372.27004 Boehringer Ingelheim Investigational Site
      • Cape Town, South Africa
        • 205.372.27008 Boehringer Ingelheim Investigational Site
      • Centurion, South Africa
        • 205.372.27006 Boehringer Ingelheim Investigational Site
      • Durban, South Africa
        • 205.372.27003 Boehringer Ingelheim Investigational Site
      • Pretoria, South Africa
        • 205.372.27005 Boehringer Ingelheim Investigational Site
      • Somerset West, South Africa
        • 205.372.27007 Boehringer Ingelheim Investigational Site
  • Spain
      • Cáceres, Spain
        • 205.372.34005 Hospital San Pedro de Alcántara
      • Madrid, Spain
        • 205.372.34004 Hospital Gregorio Marañón
      • Madrid, Spain
        • 205.372.34006 Hospital 12 de octubre
      • Terrassa (Barcelona), Spain
        • 205.372.34001 Hospital Mutua Terrassa
      • Valencia, Spain
        • 205.372.34002 Hospital Universitario Dr. Peset
  • Sweden
      • Boden, Sweden
        • 205.372.46001 Björknäs Vårdcentral
      • Höllviken, Sweden
        • 205.372.46004 Näsets läkargrupp
      • Linköping, Sweden
        • 205.372.46005 Lungmedicinska kliniken
      • Stockholm, Sweden
        • 205.372.46006 Lungmedicinska Kliniken
      • Sundsvall, Sweden
        • 205.372.46002 Alnö Vårdcentral
  • Switzerland
      • Lugano, Switzerland
        • 205.372.41002 Boehringer Ingelheim Investigational Site
      • Montana, Switzerland
        • 205.372.41003 Boehringer Ingelheim Investigational Site
      • Zürich, Switzerland
        • 205.372.41001 Boehringer Ingelheim Investigational Site
  • Taiwan
      • Kaohsiung, Taiwan
        • 205.372.88607 Kaohsiung Medical University Hospital
      • Tainan, Taiwan
        • 205.372.88606 National Cheng Kung University Hospital
      • Taipei, Taiwan
        • 205.372.88601 National Taiwan University Hospital
      • Taipei, Taiwan
        • 205.372.88602 Taipei Veterans General Hospital
      • Taipei, Taiwan
        • 205.372.88603 Mackay Memorial Hospital
      • Taipei, Taiwan
        • 205.372.88604 Tri-Service General Hospital
      • Taipei, Taiwan
        • 205.372.88608 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 205.372.88609 Boehringer Ingelheim Investigational Site
      • Taoyuan, Taiwan
        • 205.372.88605 Chang Gung Memorial Hosp-Linkou
  • Turkey
      • Ankara, Turkey
        • 205.372.90006 Gazi Universitesi Tip Fakultesi Gogus Hastaliklari A.B.D.
      • Ankara, Turkey
        • 205.372.90007 Atatürk Gög. Hastaliklari ve Cerrahisi Egitim Hastanesi
      • Bursa, Turkey
        • 205.372.90003 Uludag Universitesi Tip Fakultesi Gogus Hastaliklari
      • Edirne, Turkey
        • 205.372.90009 Trakya Universitesi Tip Fakultesi Gogus Hastaliklari A.B.D.
      • Istanbul, Turkey
        • 205.372.90004 Dr. Lütfi Kirdar Egitim ve Arastirma Hastanesi
      • Istanbul, Turkey
        • 205.372.90005 Istanbul Universitesi Cerrahpasa Tip Fakultesi
      • Izmir, Turkey
        • 205.372.90001 Izmir Tepecik Gogus Hastaliklari ve Gogus Cerrahisi Hast.
      • Kayseri, Turkey
        • 205.372.90008 Erciyes Universitesi Tip Fakultesi
      • Konya, Turkey
        • 205.372.90010 Selcuk Universitesi Tip Fakultesi
      • Samsun, Turkey
        • 205.372.90002 19 Mayis Universitesi Tip Fakultesi Gogus Hastaliklari A.B.D
  • United Kingdom
      • Aston Clinton, Aylesbury, United Kingdom
        • 205.372.44027 Boehringer Ingelheim Investigational Site
      • Carmarthen, United Kingdom
        • 205.372.44022 Boehringer Ingelheim Investigational Site
      • Chertsey, United Kingdom
        • 205.372.44002 Boehringer Ingelheim Investigational Site
      • Chesterfield, United Kingdom
        • 205.372.44023 Boehringer Ingelheim Investigational Site
      • Darlington, United Kingdom
        • 205.372.44014 Boehringer Ingelheim Investigational Site
      • East Horsley, United Kingdom
        • 205.372.44009 Boehringer Ingelheim Investigational Site
      • Fowey, United Kingdom
        • 205.372.44011 Boehringer Ingelheim Investigational Site
      • Frome, United Kingdom
        • 205.372.44003 Boehringer Ingelheim Investigational Site
      • Greenisland, United Kingdom
        • 205.372.44026 Boehringer Ingelheim Investigational Site
      • Heywood, United Kingdom
        • 205.372.44013 Boehringer Ingelheim Investigational Site
      • Isleworth, United Kingdom
        • 205.372.44016 Boehringer Ingelheim Investigational Site
      • Kirkby in Ashfield, United Kingdom
        • 205.372.44020 Boehringer Ingelheim Investigational Site
      • Mortimer, United Kingdom
        • 205.372.44024 Boehringer Ingelheim Investigational Site
      • Nottingham, United Kingdom
        • 205.372.44001 Boehringer Ingelheim Investigational Site
      • Penzance, United Kingdom
        • 205.372.44018 Boehringer Ingelheim Investigational Site
      • Plymouth, United Kingdom
        • 205.372.44021 Boehringer Ingelheim Investigational Site
      • Sheffield, United Kingdom
        • 205.372.44007 Boehringer Ingelheim Investigational Site
      • Sneinton, Nottingham, United Kingdom
        • 205.372.44010 Boehringer Ingelheim Investigational Site
      • St Just, Penzance, United Kingdom
        • 205.372.44005 Boehringer Ingelheim Investigational Site
      • St. Austell, United Kingdom
        • 205.372.44015 Boehringer Ingelheim Investigational Site
      • Sunderland, United Kingdom
        • 205.372.44006 Boehringer Ingelheim Investigational Site
      • Wellingborough, United Kingdom
        • 205.372.44008 Boehringer Ingelheim Investigational Site
      • Westbury on Trym, United Kingdom
        • 205.372.44012 Boehringer Ingelheim Investigational Site
      • Windsor, United Kingdom
        • 205.372.44028 Boehringer Ingelheim Investigational Site
      • Woking, United Kingdom
        • 205.372.44019 Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • 205.372.01012 Boehringer Ingelheim Investigational Site
      • Birmingham, Alabama, United States
        • 205.372.01020 Boehringer Ingelheim Investigational Site
      • Mobile, Alabama, United States
        • 205.372.01062 Boehringer Ingelheim Investigational Site
    • California
      • Berkeley, California, United States
        • 205.372.01048 Boehringer Ingelheim Investigational Site
      • Huntington Park, California, United States
        • 205.372.01037 Boehringer Ingelheim Investigational Site
      • Long Beach, California, United States
        • 205.372.01058 Boehringer Ingelheim Investigational Site
      • Long Beach, California, United States
        • 205.372.01059 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, United States
        • 205.372.01007 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, United States
        • 205.372.01034 Boehringer Ingelheim Investigational Site
      • Rancho Mirage, California, United States
        • 205.372.01028 Boehringer Ingelheim Investigational Site
      • San Diego, California, United States
        • 205.372.01011 Boehringer Ingelheim Investigational Site
    • Colorado
      • Boulder, Colorado, United States
        • 205.372.01066 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Norwalk, Connecticut, United States
        • 205.372.01008 Boehringer Ingelheim Investigational Site
    • Florida
      • Brandon, Florida, United States
        • 205.372.01004 Boehringer Ingelheim Investigational Site
      • Clearwater, Florida, United States
        • 205.372.01060 Boehringer Ingelheim Investigational Site
      • Miami Beach, Florida, United States
        • 205.372.01069 Boehringer Ingelheim Investigational Site
      • West Palm Beach, Florida, United States
        • 205.372.01023 Boehringer Ingelheim Investigational Site
      • Winter Park, Florida, United States
        • 205.372.01053 Boehringer Ingelheim Investigational Site
    • Georgia
      • Calhoun, Georgia, United States
        • 205.372.01045 Boehringer Ingelheim Investigational Site
    • Illinois
      • Normal, Illinois, United States
        • 205.372.01043 Boehringer Ingelheim Investigational Site
    • Iowa
      • Dubuque, Iowa, United States
        • 205.372.01061 Boehringer Ingelheim Investigational Site
    • Kansas
      • Wichita, Kansas, United States
        • 205.372.01035 Boehringer Ingelheim Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States
        • 205.372.01049 Boehringer Ingelheim Investigational Site
    • Maine
      • Biddeford, Maine, United States
        • 205.372.01015 Boehringer Ingelheim Investigational Site
    • Maryland
      • Columbia, Maryland, United States
        • 205.372.01067 Boehringer Ingelheim Investigational Site
      • Rockville, Maryland, United States
        • 205.372.01006 Boehringer Ingelheim Investigational Site
    • Michigan
      • Detroit, Michigan, United States
        • 205.372.01013 Boehringer Ingelheim Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States
        • 205.372.01003 Boehringer Ingelheim Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States
        • 205.372.01021 Boehringer Ingelheim Investigational Site
      • St. Louis, Missouri, United States
        • 205.372.01014 Boehringer Ingelheim Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States
        • 205.372.01036 Boehringer Ingelheim Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • 205.372.01046 Boehringer Ingelheim Investigational Site
    • New York
      • Mineola, New York, United States
        • 205.372.01024 Boehringer Ingelheim Investigational Site
      • Rochester, New York, United States
        • 205.372.01029 Boehringer Ingelheim Investigational Site
      • Syracuse, New York, United States
        • 205.372.01030 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • 205.372.01026 Boehringer Ingelheim Investigational Site
      • Charlotte, North Carolina, United States
        • 205.372.01019 Boehringer Ingelheim Investigational Site
      • Elizabeth City, North Carolina, United States
        • 205.372.01027 Boehringer Ingelheim Investigational Site
      • Raleigh, North Carolina, United States
        • 205.372.01038 Boehringer Ingelheim Investigational Site
      • Winston-Salem, North Carolina, United States
        • 205.372.01031 Boehringer Ingelheim Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States
        • 205.372.01017 Boehringer Ingelheim Investigational Site
      • Cincinnati, Ohio, United States
        • 205.372.01041 Boehringer Ingelheim Investigational Site
      • Cincinnati, Ohio, United States
        • 205.372.01044 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • 205.372.01001 Boehringer Ingelheim Investigational Site
    • Oregon
      • Eugene, Oregon, United States
        • 205.372.01063 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • 205.372.01068 Boehringer Ingelheim Investigational Site
      • Swathmore, Pennsylvania, United States
        • 205.372.01056 Boehringer Ingelheim Investigational Site
    • Texas
      • Dallas, Texas, United States
        • 205.372.01039 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, United States
        • 205.372.01050 Boehringer Ingelheim Investigational Site
      • Fort Worth, Texas, United States
        • 205.372.01005 Boehringer Ingelheim Investigational Site
      • Killeen, Texas, United States
        • 205.372.01018 Boehringer Ingelheim Investigational Site
      • New Braunfels, Texas, United States
        • 205.372.01040 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 205.372.01052 Boehringer Ingelheim Investigational Site
    • Virginia
      • Danville, Virginia, United States
        • 205.372.01022 Boehringer Ingelheim Investigational Site
      • Lynchburg, Virginia, United States
        • 205.372.01065 Boehringer Ingelheim Investigational Site
      • Richmond, Virginia, United States
        • 205.372.01055 Boehringer Ingelheim Investigational Site
    • Washington
      • Tacoma, Washington, United States
        • 205.372.01064 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female
  2. At least 40 years old
  3. Smoker or ex-smoker
  4. Smoking history > 10 pack-years
  5. Forced Expiratory Volume in 1 Second (FEV1) < 60% predicted

Exclusion Criteria:

  1. Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
  2. History of asthma or allergic conditions.
  3. Malignancy requiring treatment within past 5 years
  4. Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
  5. Known active tuberculosis
  6. Known hypersensitivity to anticholinergic drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Tiotropium
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Drug: Tiotropium
Other: Placebo
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Device: Respimat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337
Time Frame: Baseline and Day 337
Trough FEV1 is defined as the FEV1 measured at the -10 min time point at the end of the dosing interval (24 h post drug administration).
Baseline and Day 337
Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Time Frame: During actual study treatment period (planned Day 1 to Day 337)
Time to first COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation.
During actual study treatment period (planned Day 1 to Day 337)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29
Time Frame: Baseline and Day 29
Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.
Baseline and Day 29
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169
Time Frame: Baseline and Day 169
Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.
Baseline and Day 169
Number of COPD Exacerbations Per Patient - Exposure Adjusted
Time Frame: During actual study treatment period (planned Day 1 to Day 337)
Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. number of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)
During actual study treatment period (planned Day 1 to Day 337)
Number of COPD Exacerbations Per Patient - naïve Estimate
Time Frame: During actual study treatment period (planned Day 1 to Day 337)
Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)
During actual study treatment period (planned Day 1 to Day 337)
Number of Patients With at Least One COPD Exacerbation
Time Frame: During actual study treatment period (planned Day 1 to Day 337)
Number of patients with at least one COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)
During actual study treatment period (planned Day 1 to Day 337)
Time to First Hospitalisation for COPD Exacerbation
Time Frame: During actual study treatment period (planned Day 1 to Day 337)
Time to first hospitalisation for COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation
During actual study treatment period (planned Day 1 to Day 337)
Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted
Time Frame: During actual study treatment period (planned Day 1 to Day 337)
Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. no. of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)
During actual study treatment period (planned Day 1 to Day 337)
Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate
Time Frame: During actual study treatment period (planned Day 1 to Day 337)
Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)
During actual study treatment period (planned Day 1 to Day 337)
Number of Patients With at Least One Hospitalisation for a COPD Exacerbation
Time Frame: During actual study treatment period (planned Day 1 to Day 337)
Number of patients with at least one hospitalisation for a COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)
During actual study treatment period (planned Day 1 to Day 337)
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 337
Time Frame: Baseline and Day 337
The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Baseline and Day 337
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 169
Time Frame: Baseline and Day 169
The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Baseline and Day 169
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 337
Time Frame: Baseline and Day 337
The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Baseline and Day 337
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 169
Time Frame: Baseline and Day 169
The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Baseline and Day 169
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 29
Time Frame: Baseline and Day 29
Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.
Baseline and Day 29
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 169
Time Frame: Baseline and Day 169
Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.
Baseline and Day 169
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 337
Time Frame: Baseline and Day 337
Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.
Baseline and Day 337
Marked Changes From Baseline in Vital Signs at End of Treatment
Time Frame: Baseline and end of treatment

Marked changes from baseline in vital signs (diastolic and systolic blood pressure (DBP and SBP) and pulse rate (PR)) at end of treatment.

SBP - Increase means SBP >150 mmHg and an increase above baseline of >25 mmHg. SBP - Decrease means SBP <100 mmHg and a decrease below baseline of >10 mmHg.

DBP - Increase means DBP >90 mmHg and an increase above baseline of >10 mmHg. DBP - Decrease means DBP <60 mmHg and a decrease below baseline of >10 mmHg.

PR - Increase means PR >100 bpm and an increase above baseline of >10 bpm. PR - Decrease means PR <60 bpm and a decrease below baseline of >10 bpm.
Baseline and end of treatment
Clinically Relevant Findings in Physical Examination and ECG
Time Frame: End of treatment
Clinically relevant findings in Physical Examination and ECG at end of treatment
End of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

October 11, 2006

First Submitted That Met QC Criteria

October 11, 2006

First Posted (Estimate)

October 12, 2006

Study Record Updates

Last Update Posted (Estimate)

May 16, 2014

Last Update Submitted That Met QC Criteria

May 7, 2014

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205.372
  • 2006-001009-27

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.

Clinical Trials on Pulmonary Disease, Chronic Obstructive

Clinical Trials on Tiotropium

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe