Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients

May 15, 2014 updated by: Boehringer Ingelheim

A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Rate of Decline of Lung Function With Tiotropium 18 mcg Inhalation Capsule Once Daily in Patients With Chronic Obstructive Pulmonary Disease (COPD).

The primary objective of this trial is to determine whether daily treatment with tiotropium (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of decline in lung function over time in patients with COPD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5993

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

  • Argentina
      • Buenos Aires, Argentina
        • 205.235.101
      • Capital Federal, Argentina
        • 205.235.101 Boehringer Ingelheim Investigational Site
      • Capital Federal, Argentina
        • 205.235.103 Hospital Alemán
      • Capital Federal, Argentina
        • 205.235.104 Hospital de Clinicas José de San Martín
      • Capital Federal, Argentina
        • 205.235.105 Hospital General de Agudos José María Ramos Mejía
      • Capital Federal, Argentina
        • 205.235.107 Policlínica Bancaria
      • Capital Federal, Argentina
        • 205.235.108 Hospital General de Agudos Dr. Enrique Tornú
      • Capital Federal, Argentina
        • 205.235.109 Hospital Muñiz
      • Parque Velez Sarlfield, Argentina
        • 205.235.110 Hospital Privado - Centro Médico de Córdoba S.A.
      • Rosario, Argentina
        • 205.235.102 Instituto Cardiovascular de Rosario
      • Vicente López, Argentina
        • 205.235.106 Hospital Cetrángolo
  • Australia
    • New South Wales
      • Bankstown, New South Wales, Australia
        • 205.235.0205 Boehringer Ingelheim Investigational Site
      • Concord, New South Wales, Australia
        • 205.235.0202 Boehringer Ingelheim Investigational Site
      • Westmead, New South Wales, Australia
        • 205.235.0209 Boehringer Ingelheim Investigational Site
    • Queensland
      • Cairns, Queensland, Australia
        • 205.235.0204 Boehringer Ingelheim Investigational Site
      • Redcliffe, Queensland, Australia
        • 205.235.0203 Boehringer Ingelheim Investigational Site
    • South Australia
      • Port Lincoln, South Australia, Australia
        • 205.235.0207 Boehringer Ingelheim Investigational Site
    • Victoria
      • Box Hill, Victoria, Australia
        • 205.235.0206 Boehringer Ingelheim Investigational Site
      • Geelong, Victoria, Australia
        • 205.235.0201 Boehringer Ingelheim Investigational Site
  • Austria
      • Graz, Austria
        • 205.235.0303 Boehringer Ingelheim Investigational Site
      • Innsbruck, Austria
        • 205.235.0305 Boehringer Ingelheim Investigational Site
      • Leoben, Austria
        • 205.235.0304 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 205.235.0301 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 205.235.0302 Boehringer Ingelheim Investigational Site
  • Belgium
      • Anderlecht, Belgium
        • 205.235.0439 Boehringer Ingelheim Investigational Site
      • Baudour, Belgium
        • 205.235.0429 Boehringer Ingelheim Investigational Site
      • Brugge, Belgium
        • 205.235.0421 Boehringer Ingelheim Investigational Site
      • Brussel, Belgium
        • 205.235.0424 Boehringer Ingelheim Investigational Site
      • Bruxelles, Belgium
        • 205.235.0432 Boehringer Ingelheim Investigational Site
      • Bruxelles, Belgium
        • 205.235.0434 Boehringer Ingelheim Investigational Site
      • Dendermonde, Belgium
        • 205.235.0422 Boehringer Ingelheim Investigational Site
      • Edegem, Belgium
        • 205.235.0405 Boehringer Ingelheim Investigational Site
      • Gent, Belgium
        • 205.235.0414 Boehringer Ingelheim Investigational Site
      • Gent, Belgium
        • 205.235.0418 U.Z. Gent
      • Herentals, Belgium
        • 205.235.0417 Boehringer Ingelheim Investigational Site
      • Ieper, Belgium
        • 205.235.0402 Boehringer Ingelheim Investigational Site
      • Kortrijk, Belgium
        • 205.235.0409 Boehringer Ingelheim Investigational Site
      • Leuven, Belgium
        • 205.235.0407 Boehringer Ingelheim Investigational Site
      • Luxembourg, Belgium
        • 205.235.0440 Boehringer Ingelheim Investigational Site
      • Menen, Belgium
        • 205.235.0403 Boehringer Ingelheim Investigational Site
      • Merksem, Belgium
        • 205.235.0406 Boehringer Ingelheim Investigational Site
      • Middelheim, Belgium
        • 205.235.0404 Boehringer Ingelheim Investigational Site
      • Mons, Belgium
        • 205.235.0438 Boehringer Ingelheim Investigational Site
      • Namur, Belgium
        • 205.235.0437 Boehringer Ingelheim Investigational Site
      • Neerpelt, Belgium
        • 205.235.0420 Boehringer Ingelheim Investigational Site
      • Nobressart (ATTERT), Belgium
        • 205.235.0435 Boehringer Ingelheim Investigational Site
      • Oostende, Belgium
        • 205.235.0423 Boehringer Ingelheim Investigational Site
      • Tournai, Belgium
        • 205.235.0433 Boehringer Ingelheim Investigational Site
      • Turnhout, Belgium
        • 205.235.0412 Boehringer Ingelheim Investigational Site
      • Turnhout, Belgium
        • 205.235.0413 Boehringer Ingelheim Investigational Site
      • Yvoir, Belgium
        • 205.235.0428 Boehringer Ingelheim Investigational Site
  • Brazil
      • Florianópolis - SC, Brazil
        • 205.235.510 Servico de Pneumologia
      • Juiz de Fora - MG, Brazil
        • 205.235.508
      • Porto Alegre - RS, Brazil
        • 205.235.501
      • Porto Alegre - RS, Brazil
        • 205.235.503
      • Porto Alegre - RS, Brazil
        • 205.235.506
      • Porto Alegre - RS, Brazil
        • 205.235.507 Depto.de Medicina Interna-Servico de pneumologia
      • Rio de Janeiro - RJ, Brazil
        • 205.235.502
      • Rio de Janeiro - RJ, Brazil
        • 205.235.505 Dep.Medicina Especializada (DEMESP)
      • Salvador - BA, Brazil
        • 205.235.511 Departamento de Pneumologia
      • Santo André - SP, Brazil
        • 205.235.504 ANEXO 2-Laboratório de Funcao Pulmonar
      • São Paulo - SP, Brazil
        • 205.235.512
      • São Paulo - SP, Brazil
        • 205.235.513
      • São Paulo - SP, Brazil
        • 205.235.514 Unidade de Coracao e Pulmao do Dto. de Medicina
      • São Paulo - SP, Brazil
        • 205.235.515 Lar Escola São Francisco / Setor de Pneumologia
  • Czech Republic
      • Benesov, Czech Republic
        • 205.235.0712 Boehringer Ingelheim Investigational Site
      • Beroun, Czech Republic
        • 205.235.0711 Boehringer Ingelheim Investigational Site
      • Brno, Czech Republic
        • 205.235.0718 Clinic of Functional Diagnostics and Rehabilitation
      • Brno, Czech Republic
        • 205.235.0725 University Hospital Brno
      • Cesky Tesin, Czech Republic
        • 205.235.0720 Office of Pulmonology and Respiratory Diseases
      • Hradec Kralove, Czech Republic
        • 205.235.0717 Pulmonary Clinic
      • Jablonec nad Nisou, Czech Republic
        • 205.235.0705 Boehringer Ingelheim Investigational Site
      • Jaromer, Czech Republic
        • 205.235.0726 Private Office of Pulmonary Diseases
      • Kromeriz, Czech Republic
        • 205.235.0722 Hospital Kromeriz
      • Kyjov, Czech Republic
        • 205.235.0724 District Hospital Kyjov
      • Lovosice, Czech Republic
        • 205.235.0704 Boehringer Ingelheim Investigational Site
      • Marianske Lazne, Czech Republic
        • 205.235.0702 Boehringer Ingelheim Investigational Site
      • Plzen, Czech Republic
        • 205.235.0701 Boehringer Ingelheim Investigational Site
      • Plzen, Czech Republic
        • 205.235.0703 Boehringer Ingelheim Investigational Site
      • Prague 5, Czech Republic
        • 205.235.0710 Boehringer Ingelheim Investigational Site
      • Praha 4, Czech Republic
        • 205.235.0706 Boehringer Ingelheim Investigational Site
      • Praha 4, Czech Republic
        • 205.235.0709 Boehringer Ingelheim Investigational Site
      • Praha 5, Czech Republic
        • 205.235.0715 Boehringer Ingelheim Investigational Site
      • Praha 5 - Nove Butovice, Czech Republic
        • 205.235.0708 Boehringer Ingelheim Investigational Site
      • Praha 8, Czech Republic
        • 205.235.0707 Boehringer Ingelheim Investigational Site
      • Prerov, Czech Republic
        • 205.235.0723 Office of Pulmonary and Respiratory Diseases
      • Pribor, Czech Republic
        • 205.235.0721 Office of Pulmonary Diseases
      • Strakonice, Czech Republic
        • 205.235.0713 Boehringer Ingelheim Investigational Site
      • Tabor, Czech Republic
        • 205.235.0714 Boehringer Ingelheim Investigational Site
      • Usti nad Orlici, Czech Republic
        • 205.235.0719 Office of Pulmonology and Respiratory Diseases
      • Znojmo, Czech Republic
        • 205.235.0716 Boehringer Ingelheim Investigational Site
  • Denmark
      • Aalborg, Denmark
        • 205.235.0804 Boehringer Ingelheim Investigational Site
      • Aalborg SV, Denmark
        • 205.235.0826 Boehringer Ingelheim Investigational Site
      • Aarhus, Denmark
        • 205.235.0803 Boehringer Ingelheim Investigational Site
      • Copenhagen, Denmark
        • 205.235.0831 Boehringer Ingelheim Investigational Site
      • Copenhagen K, Denmark
        • 205.235.0828 Boehringer Ingelheim Investigational Site
      • Copenhagen NV, Denmark
        • 205.235.0802 Boehringer Ingelheim Investigational Site
      • Frederikshavn, Denmark
        • 205.235.0821 Boehringer Ingelheim Investigational Site
      • Frederikssund, Denmark
        • 205.235.0832 Boehringer Ingelheim Investigational Site
      • Fåborg, Denmark
        • 205.235.0807 Boehringer Ingelheim Investigational Site
      • Hellerup, Denmark
        • 205.235.0805 Boehringer Ingelheim Investigational Site
      • Hellerup, Denmark
        • 205.235.0835 Boehringer Ingelheim Investigational Site
      • Helsingor, Denmark
        • 205.235.0816 Boehringer Ingelheim Investigational Site
      • Hillerød, Denmark
        • 205.235.0811 Boehringer Ingelheim Investigational Site
      • Hobro, Denmark
        • 205.235.0834 Boehringer Ingelheim Investigational Site
      • Holbæk, Denmark
        • 205.235.0806 Boehringer Ingelheim Investigational Site
      • Holstebro, Denmark
        • 205.235.0814 Boehringer Ingelheim Investigational Site
      • Hvidovre, Denmark
        • 205.235.0801 Boehringer Ingelheim Investigational Site
      • Kalundborg, Denmark
        • 205.235.0833 Boehringer Ingelheim Investigational Site
      • Kolding, Denmark
        • 205.235.0830 Boehringer Ingelheim Investigational Site
      • Nykobing F., Denmark
        • 205.235.0819 Boehringer Ingelheim Investigational Site
      • Næstved, Denmark
        • 205.235.0810 Boehringer Ingelheim Investigational Site
      • Odense C, Denmark
        • 205.235.0809 Boehringer Ingelheim Investigational Site
      • Randers, Denmark
        • 205.235.0815 Boehringer Ingelheim Investigational Site
      • Silkeborg, Denmark
        • 205.235.0824 Boehringer Ingelheim Investigational Site
      • Skive, Denmark
        • 205.235.0813 Boehringer Ingelheim Investigational Site
      • Skive, Denmark
        • 205.235.0822 Boehringer Ingelheim Investigational Site
      • Slagelse, Denmark
        • 205.235.0820 Boehringer Ingelheim Investigational Site
      • Svendborg, Denmark
        • 205.235.0808 Boehringer Ingelheim Investigational Site
      • Værløse, Denmark
        • 205.235.0827 Boehringer Ingelheim Investigational Site
  • Finland
      • Helsinki, Finland
        • 205.235.0903 Boehringer Ingelheim Investigational Site
      • Jyväskylä, Finland
        • 205.235.0901 Boehringer Ingelheim Investigational Site
      • Kotka, Finland
        • 205.235.0905 Boehringer Ingelheim Investigational Site
      • Lahti, Finland
        • 205.235.0904 Boehringer Ingelheim Investigational Site
      • Pori, Finland
        • 205.235.0902 Boehringer Ingelheim Investigational Site
  • France
      • Albi, France
        • 205.235.1007 Cabinet Médical
      • Albi cedex 9, France
        • 205.235.1004 Clinique Toulouse Lautrec
      • Barbezieux St Hilaire, France
        • 205.235.1015 Centre Hospitalier
      • Bourges, France
        • 205.235.1012 Cabinet Médical
      • Chamalières, France
        • 205.235.1024 Cabinet Médical
      • Chauny cedex, France
        • 205.235.1006 Centre Hospitalier de Chauny
      • Cholet, France
        • 205.235.1005 Polyclinique
      • La Teste, France
        • 205.235.1013 Cabinet Médical
      • Marseille, France
        • 205.235.1020 Cabinet Médical
      • Montauban, France
        • 205.235.1023 Cabinet Médical
      • Nantes, France
        • 205.235.1025 Centre Médical Erdre Saint Augustin
      • Nice, France
        • 205.235.1002 Cabinet médical
      • Paris, France
        • 205.235.1001 Hôpital Bichat
      • Provins, France
        • 205.235.1016 Cabinet Médical
      • Strasbourg, France
        • 205.235.1019 Cabinet Médical
      • Tarbes cedex 9, France
        • 205.235.1009 Centre Hospitalier de Bigorre
      • Toulouse, France
        • 205.235.1021 Clinique Pasteur
  • Germany
      • Berlin, Germany
        • 205.235.1113 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 205.235.1114 Boehringer Ingelheim Investigational Site
      • Brake, Germany
        • 205.235.1103 Boehringer Ingelheim Investigational Site
      • Braunschweig, Germany
        • 205.235.1105 Boehringer Ingelheim Investigational Site
      • Bruchsal, Germany
        • 205.235.1104 Boehringer Ingelheim Investigational Site
      • Hannover, Germany
        • 205.235.1115 Boehringer Ingelheim Investigational Site
      • Kaufbeuren, Germany
        • 205.235.1109 Boehringer Ingelheim Investigational Site
      • Lörrach, Germany
        • 205.235.1108 Boehringer Ingelheim Investigational Site
      • Lübeck, Germany
        • 205.235.1102 Boehringer Ingelheim Investigational Site
      • München, Germany
        • 205.235.1106 Boehringer Ingelheim Investigational Site
      • München, Germany
        • 205.235.1110 Boehringer Ingelheim Investigational Site
      • Ulm, Germany
        • 205.235.1101 Boehringer Ingelheim Investigational Site
      • Weyhe, Germany
        • 205.235.1107 Boehringer Ingelheim Investigational Site
      • Wiesloch, Germany
        • 205.235.1112 Boehringer Ingelheim Investigational Site
  • Greece
      • Athens, Greece
        • 205.235.1202 8th Pulmonology Clinic "Sotiria" Athens Chest Hospital
      • Athens, Greece
        • 205.235.1203 Boehringer Ingelheim Investigational Site
      • Heraklion, Greece
        • 205.235.1201 Boehringer Ingelheim Investigational Site
      • Kavala, Greece
        • 205.235.1211 Boehringer Ingelheim Investigational Site
      • Larissa, Greece
        • 205.235.1204 Boehringer Ingelheim Investigational Site
      • Patra, Greece
        • 205.235.1209 Boehringer Ingelheim Investigational Site
      • Patra, Greece
        • 205.235.1210 Boehringer Ingelheim Investigational Site
      • Thessaloniki, Greece
        • 205.235.1205 Boehringer Ingelheim Investigational Site
      • Thessaloniki, Greece
        • 205.235.1206 Boehringer Ingelheim Investigational Site
      • Thessaloniki, Greece
        • 205.235.1207 Boehringer Ingelheim Investigational Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • 205.235.1401 Boehringer Ingelheim Investigational Site
      • Hong Kong, Hong Kong
        • 205.235.1403 Boehringer Ingelheim Investigational Site
      • Kowloon, Hong Kong
        • 205.235.1402 Boehringer Ingelheim Investigational Site
      • Kowloon, Hong Kong
        • 205.235.1404 Boehringer Ingelheim Investigational Site
  • Hungary
      • Budapest, Hungary
        • 205.235.1303 Boehringer Ingelheim Investigational Site
      • Budapest, Hungary
        • 205.235.1308 Boehringer Ingelheim Investigational Site
      • Budapest, Hungary
        • 205.235.1309 Boehringer Ingelheim Investigational Site
      • Budapest, Hungary
        • 205.235.1310 Boehringer Ingelheim Investigational Site
      • Budapest, Hungary
        • 205.235.1311 Boehringer Ingelheim Investigational Site
      • Debrecen, Hungary
        • 205.235.1318 Boehringer Ingelheim Investigational Site
      • Deszk, Hungary
        • 205.235.1314 Boehringer Ingelheim Investigational Site
      • Erd, Hungary
        • 205.235.1306 Boehringer Ingelheim Investigational Site
      • Farkasgyepü, Hungary
        • 205.235.1315 Boehringer Ingelheim Investigational Site
      • Gyula, Hungary
        • 205.235.1320 Boehringer Ingelheim Investigational Site
      • Kiskunhalas, Hungary
        • 205.235.1307 Boehringer Ingelheim Investigational Site
      • Miskolc, Hungary
        • 205.235.1304 Boehringer Ingelheim Investigational Site
      • Mosonmagyarovar, Hungary
        • 205.235.1317 Boehringer Ingelheim Investigational Site
      • Pecs, Hungary
        • 205.235.1301 Boehringer Ingelheim Investigational Site
      • Solymar, Hungary
        • 205.235.1313 Boehringer Ingelheim Investigational Site
      • Sopron, Hungary
        • 205.235.1305 Boehringer Ingelheim Investigational Site
      • Szombathely, Hungary
        • 205.235.1319 Boehringer Ingelheim Investigational Site
      • Tatabanya, Hungary
        • 205.235.1302 Boehringer Ingelheim Investigational Site
      • Törökbalint, Hungary
        • 205.235.1316 Boehringer Ingelheim Investigational Site
      • Veszprem, Hungary
        • 205.235.1312 Boehringer Ingelheim Investigational Site
  • Ireland
      • Dublin 15, Ireland
        • 205.235.1505 Boehringer Ingelheim Investigational Site
      • Dublin 4, Ireland
        • 205.235.1503 Boehringer Ingelheim Investigational Site
      • Dublin 9, Ireland
        • 205.235.1501 Boehringer Ingelheim Investigational Site
  • Italy
      • Alessandria, Italy
        • 205.235.1631 A. O. SS. Antonio e Biagio e Arrigo
      • Avellino, Italy
        • 205.235.1613 A. O. S. Giuseppe Moscati
      • Bologna, Italy
        • 205.235.1618 Ospedale Bellaria
      • Busto Arsizio (VA), Italy
        • 205.235.1649 Ospedale di Circolo di Busto Arsizio
      • CASSANO D'ADDA (Milano), Italy
        • 205.235.1645 Ospedale Civile "Zappatoni"
      • Cagliari, Italy
        • 205.235.1635 P. O. Roberto Binaghi
      • Carrara (Massa), Italy
        • 205.235.1623 A. O. di Carrara
      • Chieti, Italy
        • 205.235.1617 Ospedale S. Camillo De Lellis
      • Erice (Trapani), Italy
        • 205.235.1612 A. O. S. Antonio Abate
      • Ferrara, Italy
        • 205.235.1622 A. O. S. Anna
      • Firenze, Italy
        • 205.235.1646 A. O. di Careggi
      • Firenze, Italy
        • 205.235.1647 A. O. Careggi
      • Genova, Italy
        • 205.235.1615 Ospedale S. Martino
      • Gubbio (Perugia), Italy
        • 205.235.1603 P. O. di Gubbio
      • Iglesias (Cagliari), Italy
        • 205.235.1619 A. O. Fratelli Crobu
      • L'Aquila, Italy
        • 205.235.1648 Ospedale "S. Maria di Collemaggio"
      • Macerata, Italy
        • 205.235.1624 Ospedale di Macerata
      • Milano, Italy
        • 205.235.1634 P. O. Luigi Sacco
      • Modica (Ragusa), Italy
        • 205.235.1639 Ospedale Maggiore
      • Orbassano (Torino), Italy
        • 205.235.1629 A. O. S. Luigi Gonzaga
      • Perugia, Italy
        • 205.235.1604 P. O. R. Silvestrini
      • Pisa, Italy
        • 205.235.1601 Presidio Ospedaliero di Cisanello
      • Pordenone, Italy
        • 205.235.1643 A. O. Santa Maria degli Angeli
      • Prato, Italy
        • 205.235.1614 Ospedale Misericordia e Dolce
      • Sassari, Italy
        • 205.235.1607 Università degli Studi di Sassari
      • Sassari, Italy
        • 205.235.1608 ASL 1 di Sassari
      • Terni, Italy
        • 205.235.1606 ASL 4 di Terni
      • Torino, Italy
        • 205.235.1632 ASL 4 - Distretto 2
      • Torrette di Ancona (Ancona), Italy
        • 205.235.1633 A. O. Umberto I
      • Treviso, Italy
        • 205.235.1640 P. O. Cà Foncello
      • Voghera (Pavia), Italy
        • 205.235.1602 Ospedale di Voghera
  • Japan
      • Bunkyo-ku, Tokyo, Japan
        • 205.235.1706 Juntendo University Hospital
      • Kamogawa, Chiba, Japan
        • 205.235.1705 Kameda Medical Center
      • Komaki, Aichi, Japan
        • 205.235.1713 Komaki City Hospital
      • Kurume, Fukuoka, Japan
        • 205.235.1712 Kurume University Hospital
      • Matsumoto, Nagano, Japan
        • 205.235.1708 Shinshu University
      • Morioka, Iwate, Japan
        • 205.235.1702 Iwate Medical University Hospital
      • Osaka, Osaka, Japan
        • 205.235.1710 Osaka City University Hospital
      • Osakasayama, Osaka, Japan
        • 205.235.1711 Kinki University Hospital
      • Sapporo, Hokkaido, Japan
        • 205.235.1701 Hokkaido University
      • Sendai, Miyagi, Japan
        • 205.235.1703 Tohoku University Hospital
      • Seto, Aichi, Japan
        • 205.235.1709 Tosei General Hospital
      • Yokote, Akita, Japan
        • 205.235.1704 Hiraka General Hospital
  • Lithuania
      • Kaunas, Lithuania
        • 205.235.1801 Boehringer Ingelheim Investigational Site
      • Kaunas, Lithuania
        • 205.235.1802 Boehringer Ingelheim Investigational Site
      • Vilnius, Lithuania
        • 205.235.1803 Boehringer Ingelheim Investigational Site
  • Malaysia
      • Kuala Lumpur, Malaysia
        • 205.235.1901 Boehringer Ingelheim Investigational Site
      • Kuala Lumpur, Malaysia
        • 205.235.1902 Boehringer Ingelheim Investigational Site
      • Kuala Lumpur, Malaysia
        • 205.235.1903 Boehringer Ingelheim Investigational Site
  • Mexico
      • Ciudad de Mexico, Mexico
        • 205.235.2005
      • Ciudad de Mexico, Mexico
        • 205.235.2006 Tlalpan 4000, Pabellón 5, EPOC
      • Col. Mitras Centro, Monterrey, N.L., Mexico
        • 205.235.2004 Edif. Dr. Rodrigo F. Barragan, P.B.
      • Guadalajara, Jal., Mexico
        • 205.235.2002
      • Puebla, Mexico
        • 205.235.2009
      • Toluca, Mexico
        • 205.235.2010 Depto. De Ivestigación
      • Zapopan, jalisco, Mexico
        • 205.235.2003
  • Netherlands
      • Almelo, Netherlands
        • 205.235.2110 Poli Longziekten
      • Amersfoort, Netherlands
        • 205.235.2105 Lokatie De Lichtenberg
      • Delft, Netherlands
        • 205.235.2107 Poli Longziekten
      • Dordrecht, Netherlands
        • 205.235.2106 Lokatie Dordwijk
      • Eindhoven, Netherlands
        • 205.235.2104 Poli longziekten
      • Groningen, Netherlands
        • 205.235.2102 Martini Ziekenhuis Groningen
      • Harderwijk, Netherlands
        • 205.235.2112 Poli Longziekten
      • Heerenveen, Netherlands
        • 205.235.2115 Poli Longziekten
      • Heerlen, Netherlands
        • 205.235.2101 Atrium medisch centrum
      • Hengelo, Netherlands
        • 205.235.2114 Poli Longziekten
      • Leeuwarden, Netherlands
        • 205.235.2108 Poli Longziekten
      • Rotterdam, Netherlands
        • 205.235.2109 Poli Longziekten
      • Sneek, Netherlands
        • 205.235.2111 Antonius Ziekenhuis
  • New Zealand
      • Auckland, New Zealand
        • 205.235.0211 Boehringer Ingelheim Investigational Site
      • Christchurch, New Zealand, New Zealand
        • 205.235.0212 Boehringer Ingelheim Investigational Site
  • Norway
      • Arendal, Norway
        • 205.235.2202 Boehringer Ingelheim Investigational Site
      • Fredrikstad, Norway
        • 205.235.2201 Boehringer Ingelheim Investigational Site
      • Sandvika, Norway
        • 205.235.2205 Boehringer Ingelheim Investigational Site
      • Straume, Norway
        • 205.235.2204 Boehringer Ingelheim Investigational Site
  • Philippines
      • Manila, Philippines
        • 205.235.2301 Philippine General Hospital
      • Manila, Philippines
        • 205.235.2305 University of Santo Tomas Hospital
      • Quezon City, Philippines
        • 205.235.2302 Philippine Heart Center
      • Quezon City, Philippines
        • 205.235.2303 Veterans Memorial Medical Center
      • Quezon City, Philippines
        • 205.235.2304 Lung Center of the Philippines
  • Poland
      • Gdansk, Poland
        • 205.235.2410 Boehringer Ingelheim Investigational Site
      • Katowice, Poland
        • 205.235.2407 Boehringer Ingelheim Investigational Site
      • Krakow, Poland
        • 205.235.2408 Boehringer Ingelheim Investigational Site
      • Lodz, Poland
        • 205.235.2405 Boehringer Ingelheim Investigational Site
      • Lodz, Poland
        • 205.235.2409 Boehringer Ingelheim Investigational Site
      • Warsaw, Poland
        • 205.235.2401 Boehringer Ingelheim Investigational Site
      • Warsaw, Poland
        • 205.235.2402 Boehringer Ingelheim Investigational Site
      • Warsaw, Poland
        • 205.235.2403 Boehringer Ingelheim Investigational Site
      • Wroclaw, Poland
        • 205.235.2404 Boehringer Ingelheim Investigational Site
      • Zabrze, Poland
        • 205.235.2406 Boehringer Ingelheim Investigational Site
  • Portugal
      • Coimbra, Portugal
        • 205.235.2504 Centro Hospitalar de Coimbra
      • Lisboa, Portugal
        • 205.235.2503 Hospital Pulido Valente
      • Lisboa, Portugal
        • 205.235.2505 Hospital de Santa Marta
      • Porto, Portugal
        • 205.235.2501 Hospital de São João
      • Vila Nova de Gaia, Portugal
        • 205.235.2502 Centro Hospitalar de Vila Nova de Gaia
  • Russian Federation
      • Moscow, Russian Federation
        • 205.235.2601 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 205.235.2602 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 205.235.2603 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 205.235.2605 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 205.235.2604 Boehringer Ingelheim Investigational Site
  • Singapore
      • Singapore, Singapore
        • 205.235.1904 Boehringer Ingelheim Investigational Site
      • Singapore, Singapore
        • 205.235.1905 Boehringer Ingelheim Investigational Site
      • Singapore, Singapore
        • 205.235.1906 Boehringer Ingelheim Investigational Site
  • Slovakia
      • Bratislava, Slovakia
        • 205.235.2701 Boehringer Ingelheim Investigational Site
      • Bratislava, Slovakia
        • 205.235.2702 Boehringer Ingelheim Investigational Site
      • Martin, Slovakia
        • 205.235.2703 Boehringer Ingelheim Investigational Site
      • Poprad, Slovakia
        • 205.235.2704 Boehringer Ingelheim Investigational Site
      • Topolcany, Slovakia
        • 205.235.2705 Boehringer Ingelheim Investigational Site
  • Slovenia
      • Golnik, Slovenia
        • 205.235.2801 Boehringer Ingelheim Investigational Site
      • Golnik, Slovenia
        • 205.235.2802 Boehringer Ingelheim Investigational Site
      • Kamnik, Slovenia
        • 205.235.2805 Boehringer Ingelheim Investigational Site
      • Ljubljana, Slovenia
        • 205.235.2803 Boehringer Ingelheim Investigational Site
      • Topolsica, Slovenia
        • 205.235.2804 Boehringer Ingelheim Investigational Site
  • South Africa
      • Bloemfontein, South Africa
        • 205.235.2908
      • Cape Town, South Africa
        • 205.235.2910
      • Cape Town, South Africa
        • 205.235.2912
      • Durban, South Africa
        • 205.235.2904
      • Durban, South Africa
        • 205.235.2911
      • George, South Africa
        • 205.235.2902
      • Paarl, South Africa
        • 205.235.2905
      • Pretoria, South Africa
        • 205.235.2901 Boehringer Ingelheim Investigational Site
      • Somerset West, South Africa
        • 205.235.2906
      • Vanderbijlpark, South Africa
        • 205.235.2903
      • Welkom, South Africa
        • 205.235.2909
  • Spain
      • A Coruña, Spain
        • 205.235.3014 Complejo Hospitalario Juan Canalejo
      • Alicante, Spain
        • 205.235.3026 Hospital General Universitario de Alicante
      • Badajoz, Spain
        • 205.235.3011 Complejo Hospitalario Infanta Cristina
      • Badalona (Barcelona), Spain
        • 205.235.3006 Hospital Germans Trias i Pujol
      • Barakaldo (Bilbao), Spain
        • 205.235.3022 Hospital de Cruces
      • Barcelona, Spain
        • 205.235.3003 Hospital Clínic i Provincial de Barcelona
      • Barcelona, Spain
        • 205.235.3008 Hospital Vall d'Hebrón
      • Girona, Spain
        • 205.235.3023 Hospital Dr. Josep Trueta
      • Guadalajara, Spain
        • 205.235.3004 Hospital General Universitario de Guadalajara
      • Huesca, Spain
        • 205.235.3005 Hospital General San Jorge de Huesca
      • Jerez de la Frontera, Spain
        • 205.235.3021 Hospital de Jerez de la Frontera
      • Leganés, Madrid, Spain
        • 205.235.3010 Hospital Severo Ochoa
      • Madrid, Spain
        • 205.235.3009 Hospital Clínico San Carlos
      • Madrid, Spain
        • 205.235.3013 Clínica Puerta de Hierro
      • Madrid, Spain
        • 205.235.3017 Hospital Ramón y Cajal
      • Madrid, Spain
        • 205.235.3020 Hospital Universitario La Paz
      • Madrid, Spain
        • 205.235.3028 Hospital Universitario de la Princesa
      • Madrid, Spain
        • 205.235.3031 Hospital Gregorio Marañón
      • Madrid, Spain
        • 205.235.3036 Hospital 12 de Octubre
      • Málaga, Spain
        • 205.235.3033 Hospital General Carlos Haya
      • Palma de Mallorca, Spain
        • 205.235.3027 Complejo Asistencial Son Dureta
      • Pontevedra, Spain
        • 205.235.3024 Hospital de Montecelo
      • Reus (Tarragona), Spain
        • 205.235.3016 Hospital Universitari de Sant Joan
      • Sabadell (Barcelona), Spain
        • 205.235.3015 Corporació Sanitaria Parc Taulí de Sabadell
      • Santa Cruz de Tenerife, Spain
        • 205.235.3037 Hsopital Universitario Ntra. Sra. de la Candelaria
      • Santander, Spain
        • 205.235.3039 Hospital Universitario Marqués de Valdecilla
      • Sevilla, Spain
        • 205.235.3019 Hospital Vírgen de la Macarena
      • Sevilla, Spain
        • 205.235.3035 Hospital Universitario Vírgen del Rocío
      • Terrassa (Barcelona), Spain
        • 205.235.3001 Hospital Mutua Terrassa
      • Valencia, Spain
        • 205.235.3002 Hospital Clínico Universitario de Valencia
      • Valencia, Spain
        • 205.235.3025 Hospital Universitario Dr. Peset
      • Valencia, Spain
        • 205.235.3032 Hospital Arnau de Vilanova
      • Valencia, Spain
        • 205.235.3034 Hospital La Fe
      • Vigo, Spain
        • 205.235.3018 Complejo Hospitalario Xeral - Cíes
      • Zaragoza, Spain
        • 205.235.3030 Hospital Miguel Servet
      • Zaragoza, Spain
        • 205.235.3038 Hospital Clínico Lozano Blesa
  • Switzerland
      • Basel, Switzerland
        • 205.235.3202 Boehringer Ingelheim Investigational Site
      • Basel, Switzerland
        • 205.235.3203 Universitätsspital Basel
      • Faltigberg, Switzerland
        • 205.235.3204 Boehringer Ingelheim Investigational Site
      • Lugano, Switzerland
        • 205.235.3205 Boehringer Ingelheim Investigational Site
      • Montana, Switzerland
        • 205.235.3206 Boehringer Ingelheim Investigational Site
      • Winterthur, Switzerland
        • 205.235.3208 Boehringer Ingelheim Investigational Site
      • Zürich, Switzerland
        • 205.235.3201 Boehringer Ingelheim Investigational Site
  • Taiwan
      • Taipei, Taiwan
        • 205.235.3301 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 205.235.3302 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 205.235.3303 Boehringer Ingelheim Investigational Site
  • Thailand
      • Bangkok, Thailand
        • 205.235.3402 Boehringer Ingelheim Investigational Site
      • Bangkok, Thailand
        • 205.235.3403 Boehringer Ingelheim Investigational Site
      • Bangkok, Thailand
        • 205.235.3404 Boehringer Ingelheim Investigational Site
      • Chiang Mai, Thailand
        • 205.235.3401 Boehringer Ingelheim Investigational Site
      • Khon Kaen, Thailand
        • 205.235.3405 Boehringer Ingelheim Investigational Site
  • Turkey
      • Adana, Turkey
        • 205.235.3510 Cukurova Tip Fakultesi Balcali Hastanesi
      • Ankara, Turkey
        • 205.235.3506 Hacettepe Tip Fakultesi
      • Ankara, Turkey
        • 205.235.3507 Ankara SSK Diskapi Egitim Hastanesi
      • Ankara, Turkey
        • 205.235.3508 Atatürk Gögüs Hastaliklari ve Gögüs Cerrahi
      • Erzurum, Turkey
        • 205.235.3509 Atatürk Üniversitesi Tip Fakultesi Aziziye
      • Eskisehir, Turkey
        • 205.235.3511 Osmangazi Universitesi Tip Fakültesi
      • Istanbul, Turkey
        • 205.235.3501 Istanbul Universitesi Cerrahpasa Tip Fakultesi
      • Istanbul, Turkey
        • 205.235.3502 Yedikule Gögüs Hastaliklari Hastanesi
      • Istanbul, Turkey
        • 205.235.3503 Tophanelioglu Cad. No: 13/15
      • Istanbul, Turkey
        • 205.235.3504 Cevizli E5 Karayolu
      • Istanbul, Turkey
        • 205.235.3505 Istanbul Universitesi Tip Fakültesi
      • Izmir, Turkey
        • 205.235.3512 DokuzEylül Universitesi Tip Fakultesi Gögüs Hastaliklari ABD
  • United Kingdom
      • Aberdeen, United Kingdom
        • 205.235.3615 Boehringer Ingelheim Investigational Site
      • Chertsey, United Kingdom
        • 205.235.3611 Boehringer Ingelheim Investigational Site
      • Chesterfield, United Kingdom
        • 205.235.3613 Boehringer Ingelheim Investigational Site
      • Cottingham, Hull, United Kingdom
        • 205.235.3608 Boehringer Ingelheim Investigational Site
      • Exeter, United Kingdom
        • 205.235.3605 Boehringer Ingelheim Investigational Site
      • Glasgow, United Kingdom
        • 205.235.3602 Boehringer Ingelheim Investigational Site
      • Leeds, United Kingdom
        • 205.235.3610 Boehringer Ingelheim Investigational Site
      • Leicester, United Kingdom
        • 205.235.3607 Boehringer Ingelheim Investigational Site
      • Middleton, United Kingdom
        • 205.235.3604 Boehringer Ingelheim Investigational Site
      • Nottingham, United Kingdom
        • 205.235.3612 Boehringer Ingelheim Investigational Site
      • Paisley, United Kingdom
        • 205.235.3616 Boehringer Ingelheim Investigational Site
      • Penarth, United Kingdom
        • 205.235.3614 Boehringer Ingelheim Investigational Site
      • Plymouth, United Kingdom
        • 205.235.3603 Boehringer Ingelheim Investigational Site
      • Sheffield, United Kingdom
        • 205.235.3609 Boehringer Ingelheim Investigational Site
      • Solihull, Birmingham, United Kingdom
        • 205.235.3601 Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Anniston, Alabama, United States
        • 205.235.3779 Boehringer Ingelheim Investigational Site
      • Birmingham, Alabama, United States
        • 205.235.3785 Boehringer Ingelheim Investigational Site
      • Jasper, Alabama, United States
        • 205.235.3804 Boehringer Ingelheim Investigational Site
      • Mobile, Alabama, United States
        • 205.235.3795 Boehringer Ingelheim Investigational Site
    • Arizona
      • Phoenix, Arizona, United States
        • 205.235.3759 Boehringer Ingelheim Investigational Site
    • California
      • Carmichael, California, United States
        • 205.235.3770 Boehringer Ingelheim Investigational Site
      • Escondito, California, United States
        • 205.235.3778 Boehringer Ingelheim Investigational Site
      • Lakewood, California, United States
        • 205.235.3810 Boehringer Ingelheim Investigational Site
      • Long Beach, California, United States
        • 205.235.3758 Boehringer Ingelheim Investigational Site
      • Long Beach, California, United States
        • 205.235.3812 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, United States
        • 205.235.3773 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, United States
        • 205.235.3800 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, United States
        • 205.235.3802 Boehringer Ingelheim Investigational Site
      • Orange, California, United States
        • 205.235.3786 Pulmonary and Critical Care Medicine
      • Palo Alto, California, United States
        • 205.235.3811 Boehringer Ingelheim Investigational Site
      • Rancho Mirage, California, United States
        • 205.235.3741 Boehringer Ingelheim Investigational Site
      • San Diego, California, United States
        • 205.235.3717 Boehringer Ingelheim Investigational Site
      • San Diego, California, United States
        • 205.235.3781 Boehringer Ingelheim Investigational Site
      • San Diego, California, United States
        • 205.235.3784 Boehringer Ingelheim Investigational Site
      • Sepulveda, California, United States
        • 205.235.3760 Boehringer Ingelheim Investigational Site
      • Stockton, California, United States
        • 205.235.3711 Boehringer Ingelheim Investigational Site
    • Colorado
      • Denver, Colorado, United States
        • 205.235.3764 Boehringer Ingelheim Investigational Site
      • Wheat Ridge, Colorado, United States
        • 205.235.3783 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Hartford, Connecticut, United States
        • 205.235.3727 Boehringer Ingelheim Investigational Site
      • Hartford, Connecticut, United States
        • 205.235.3808 Boehringer Ingelheim Investigational Site
      • Norwalk, Connecticut, United States
        • 205.235.3793 Boehringer Ingelheim Investigational Site
      • WEst Haven, Connecticut, United States
        • 205.235.3815 Boehringer Ingelheim Investigational Site
    • Florida
      • Bay Pines, Florida, United States
        • 205.235.3706 Boehringer Ingelheim Investigational Site
      • Brandon, Florida, United States
        • 205.235.3762 Boehringer Ingelheim Investigational Site
      • Largo, Florida, United States
        • 205.235.3707 Boehringer Ingelheim Investigational Site
      • Melbourne, Florida, United States
        • 205.235.3703 Boehringer Ingelheim Investigational Site
      • Panama City, Florida, United States
        • 205.235.3775 Boehringer Ingelheim Investigational Site
      • Sarasota, Florida, United States
        • 205.235.3743 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, United States
        • 205.235.3756 Boehringer Ingelheim Investigational Site
      • West Palm Beach, Florida, United States
        • 205.235.3739 Boehringer Ingelheim Investigational Site
    • Georgia
      • Atlanta, Georgia, United States
        • 205.235.3719 Boehringer Ingelheim Investigational Site
      • Atlanta, Georgia, United States
        • 205.235.3790 Boehringer Ingelheim Investigational Site
      • Augusta, Georgia, United States
        • 205.235.3716 Boehringer Ingelheim Investigational Site
      • Stockbridge, Georgia, United States
        • 205.235.3794 Boehringer Ingelheim Investigational Site
    • Idaho
      • Coeur d'Alene, Idaho, United States
        • 205.235.3724 Boehringer Ingelheim Investigational Site
    • Illinois
      • Normal, Illinois, United States
        • 205.235.3713 Boehringer Ingelheim Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States
        • 205.235.3768 Boehringer Ingelheim Investigational Site
    • Iowa
      • Dubuque, Iowa, United States
        • 205.235.3749 Boehringer Ingelheim Investigational Site
    • Kansas
      • Olathe, Kansas, United States
        • 205.235.3757 Boehringer Ingelheim Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States
        • 205.235.3729 Boehringer Ingelheim Investigational Site
    • Louisiana
      • Metairie, Louisiana, United States
        • 205.235.3737 Boehringer Ingelheim Investigational Site
      • Shreveport, Louisiana, United States
        • 205.235.3788 Boehringer Ingelheim Investigational Site
    • Maine
      • Bidderford, Maine, United States
        • 205.235.3750 Boehringer Ingelheim Investigational Site
    • Maryland
      • Baltimore, Maryland, United States
        • 205.235.3806 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • 205.235.3721 Boehringer Ingelheim Investigational Site
      • Springfield, Massachusetts, United States
        • 205.235.3726 354 Birnie Ave
    • Michigan
      • Ann Arbor, Michigan, United States
        • 205.235.3813 Boehringer Ingelheim Investigational Site
      • Detroit, Michigan, United States
        • 205.235.3732 Boehringer Ingelheim Investigational Site
      • Livonia, Michigan, United States
        • 205.235.3809 Boehringer Ingelheim Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States
        • 205.235.3751 Boehringer Ingelheim Investigational Site
      • Minneapolis, Minnesota, United States
        • 205.235.3754 Boehringer Ingelheim Investigational Site
      • Rochester, Minnesota, United States
        • 205.235.3789 Boehringer Ingelheim Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States
        • 205.235.3734 Boehringer Ingelheim Investigational Site
      • Kansas City, Missouri, United States
        • 205.235.3814 Boehringer Ingelheim Investigational Site
      • St. Louis, Missouri, United States
        • 205.235.3747 Boehringer Ingelheim Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States
        • 205.235.3763 Boehringer Ingelheim Investigational Site
    • New Jersey
      • Cherry Hill, New Jersey, United States
        • 205.235.3797 Boehringer Ingelheim Investigational Site
      • Summit, New Jersey, United States
        • 205.235.3799 Boehringer Ingelheim Investigational Site
    • New York
      • Albany, New York, United States
        • 205.235.3796 Boehringer Ingelheim Investigational Site
      • Bayshore, New York, United States
        • 205.235.3807 Boehringer Ingelheim Investigational Site
      • Bronx, New York, United States
        • 205.235.3816 Boehringer Ingelheim Investigational Site
      • Larchmont, New York, United States
        • 205.235.3765 Boehringer Ingelheim Investigational Site
      • Mineola, New York, United States
        • 205.235.3748 Boehringer Ingelheim Investigational Site
      • New York, New York, United States
        • 205.235.3818 Boehringer Ingelheim Investigational Site
      • Rochester, New York, United States
        • 205.235.3722 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Burlington, North Carolina, United States
        • 205.235.3730 Boehringer Ingelheim Investigational Site
      • Chapel Hill, North Carolina, United States
        • 205.235.3731 Boehringer Ingelheim Investigational Site
      • Durham, North Carolina, United States
        • 205.235.3736 Boehringer Ingelheim Investigational Site
      • Elizabath City, North Carolina, United States
        • 205.235.3745 Boehringer Ingelheim Investigational Site
      • Winston-Salem, North Carolina, United States
        • 205.235.3712 Boehringer Ingelheim Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States
        • 205.235.3723 Boehringer Ingelheim Investigational Site
      • Cleveland, Ohio, United States
        • 205.235.3701 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States
        • 205.235.3791 Boehringer Ingelheim Investigational Site
    • Oregon
      • Portland, Oregon, United States
        • 205.235.3820 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States
        • 205.235.3725 Boehringer Ingelheim Investigational Site
      • Philadelphia, Pennsylvania, United States
        • 205.235.3817 Boehringer Ingelheim Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States
        • 205.235.3715 Boehringer Ingelheim Investigational Site
    • Texas
      • El Paso, Texas, United States
        • 205.235.3803 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 205.235.3742 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 205.235.3787 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 205.235.3704 Boehringer Ingelheim Investigational Site
    • Utah
      • Salt Lake City, Utah, United States
        • 205.235.3752 Boehringer Ingelheim Investigational Site
    • Virginia
      • Danville, Virginia, United States
        • 205.235.3744 Boehringer Ingelheim Investigational Site
      • Fredericksburg, Virginia, United States
        • 205.235.3782 Boehringer Ingelheim Investigational Site
      • Lynchburg, Virginia, United States
        • 205.235.3771 Boehringer Ingelheim Investigational Site
      • Richmond, Virginia, United States
        • 205.235.3738 Boehringer Ingelheim Investigational Site
      • Richmond, Virginia, United States
        • 205.235.3792 Boehringer Ingelheim Investigational Site
      • Salem, Virginia, United States
        • 205.235.3761 Boehringer Ingelheim Investigational Site
    • Washington
      • Spokane, Washington, United States
        • 205.235.3718 Boehringer Ingelheim Investigational Site
    • Wisconsin
      • La Crosse, Wisconsin, United States
        • 205.235.3780 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:

  • Written informed consent.
  • Male or female patients 40 years of age or older.
  • Smoking history of at least 10 pack years.
  • Diagnosis of COPD with post bronchodilator FEV1 less than or equal to 70% of predicted normal and FEV1<70% of FVC and on stable respiratory medication.

Exclusion Criteria:

  • Significant diseases other than COPD which in the opinion of the investigator may put the patient at risk or influence the patients ability to participate.
  • Myocardial infarction in past 6 months.
  • Unstable or life threatening arrhythmia in past year.
  • Hospitalization for NYHA heart failure class III or IV in past year.
  • Active tuberculosis.
  • Asthma.
  • Pulmonary resection.
  • Malignancy treated with radiation or chemotherapy in past 5 years.
  • Respiratory infection in 4 weeks prior to screening.
  • Known hypersensitivity to anticholinergic drugs or components.
  • Known moderate to severe renal impairment.
  • Known narrow angle glaucoma.
  • Significant symptomatic BPH or bladder neck obstruction.
  • Need for oxygen therapy >12 hr/day.
  • Use of oral corticosteroids at unstable doses or >10 mg/day.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years
Time Frame: From day 30 to 4 years
Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.
From day 30 to 4 years
Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years
Time Frame: From day 30 to 4 years
Rate of decline of forced expiratory volume in one second (FEV1) measured after bronchodilation. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.
From day 30 to 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.
Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1
Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.
Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days
Rate of decline of forced expiratory volume in one second (FEV1) measured after the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1
Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days
Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years
Time Frame: From day 30 to 4 years
Rate of decline of forced vital capacity (FVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC
From day 30 to 4 years
Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years
Time Frame: From day 30 to 4 years
Rate of decline of forced vital capacity (FVC) measured after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC
From day 30 to 4 years
Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years
Time Frame: From day 30 to 4 years
Rate of decline of slow vital capacity (SVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC
From day 30 to 4 years
Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years
Time Frame: From day 30 to 4 years
Rate of decline of slow vital capacity (SVC) measured after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC
From day 30 to 4 years
Rate of Decline of St George's Respiratory Questionnaire (SGRQ) Total Score
Time Frame: From month 6 to 4 years
SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). A negative rate of decline shows decreasing SGRQ total score (or improved health) over time, while a positive value shows increasing score (or worsen health).
From month 6 to 4 years
Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.
Rate of decline of forced vital capacity (FVC) before bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC
Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.
Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days
Rate of decline of forced vital capacity (FVC) after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC
Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days
Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days
Rate of decline slow vital capacity (SVC) before bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC
Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days
Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days
Rate of decline of slow vital capacity (SVC) after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC
Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days
Time to First Exacerbation
Time Frame: From Day 1 to 4 years
Chronic obstructive pulmonary disease (COPD) exacerbation
From Day 1 to 4 years
Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year
Time Frame: Day 1 to 4 years
Day 1 to 4 years
Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Time Frame: Day 1 to 4 years
Day 1 to 4 years
Number of Exacerbation Days Per Patient Year
Time Frame: Day 1 to 4 years
Number of exacerbation days normalized by treatment exposure
Day 1 to 4 years
Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients)
Time Frame: Day 1 to 4 years
Day 1 to 4 years
Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization
Time Frame: From Day 1 to 4 years
From Day 1 to 4 years
Number of Exacerbation Leading to Hospitalization
Time Frame: From Day 1 to 4 years
Estimated number of exacerbations leading to hospitalizations per patient year
From Day 1 to 4 years
Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization
Time Frame: From Day 1 to 4 years
Number of days with chronic obstructive pulmonary disease (COPD) exacerbation leading to hospitalization (normalized by treatment exposure)
From Day 1 to 4 years
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1
Time Frame: Month 1
Estimated FEV1 before bronchodilator at Month 1
Month 1
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1
Time Frame: Month 1
Estimated forced expiratory volume in one second (FEV1) after bronchodilator at month 1
Month 1
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6
Time Frame: Month 6
Estimated forced expiratory volume in one second (FEV1) before bronchodilator at month 6
Month 6
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6
Time Frame: Month 6
Month 6
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12
Time Frame: Month 12
Month 12
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12
Time Frame: Month 12
Month 12
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18
Time Frame: Month 18
Month 18
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18
Time Frame: Month 18
Month 18
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24
Time Frame: Month 24
Month 24
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24
Time Frame: Month 24
Month 24
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30
Time Frame: Month 30
Month 30
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30
Time Frame: Month 30
Month 30
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36
Time Frame: Month 36
Month 36
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36
Time Frame: Month 36
Month 36
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42
Time Frame: Month 42
Month 42
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42
Time Frame: Month 42
Estimated FEV1 after bronchodilator at Month 42
Month 42
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48
Time Frame: Month 48
Month 48
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48
Time Frame: Month 48
Month 48
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1
Time Frame: Month 1
Month 1
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1
Time Frame: Month 1
Month 1
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6
Time Frame: Month 6
Month 6
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6
Time Frame: Month 6
Month 6
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12
Time Frame: Month 12
Month 12
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12
Time Frame: Month 12
Month 12
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18
Time Frame: Month 18
Month 18
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18
Time Frame: Month 18
Month 18
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24
Time Frame: Month 24
Month 24
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24
Time Frame: Month 24
Month 24
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30
Time Frame: Month 30
Month 30
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30
Time Frame: Month 30
Month 30
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36
Time Frame: Month 36
Month 36
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36
Time Frame: Month 36
Month 36
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42
Time Frame: Month 42
Month 42
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42
Time Frame: Month 42
Month 42
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48
Time Frame: Month 48
Month 48
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48
Time Frame: Month 48
Month 48
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1
Time Frame: Month 1
Month 1
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1
Time Frame: Month 1
Month 1
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6
Time Frame: Month 6
Month 6
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6
Time Frame: Month 6
Month 6
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12
Time Frame: Month 12
Month 12
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12
Time Frame: Month 12
Month 12
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18
Time Frame: Month 18
Month 18
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18
Time Frame: Month 18
Month 18
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24
Time Frame: Month 24
Month 24
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24
Time Frame: Month 24
Month 24
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30
Time Frame: Month 30
Month 30
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30
Time Frame: Month 30
Month 30
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36
Time Frame: Month 36
Month 36
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36
Time Frame: Month 36
Month 36
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42
Time Frame: Month 42
Month 42
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 42
Time Frame: Month 42
Month 42
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 48
Time Frame: Month 48
Month 48
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 48
Time Frame: Month 48
Month 48
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 6
Time Frame: Month 6
  • SGRQ total score summarizes the impact of COPD on overall patient's health status.
  • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
  • The scale is continuous.
  • Rate of decline shows the yearly change of SGRQ total score.
Month 6
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 12
Time Frame: Month 12
  • SGRQ total score summarizes the impact of COPD on overall patient's health status.
  • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
  • The scale is continuous.
  • Rate of decline shows the yearly change of SGRQ total score.
Month 12
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 18
Time Frame: Month 18
  • SGRQ total score summarizes the impact of COPD on overall patient's health status.
  • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
  • The scale is continuous.
  • Rate of decline shows the yearly change of SGRQ total score.
Month 18
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 24
Time Frame: Month 24
  • SGRQ total score summarizes the impact of COPD on overall patient's health status.
  • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
  • The scale is continuous.
  • Rate of decline shows the yearly change of SGRQ total score.
Month 24
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 30
Time Frame: Month 30
  • SGRQ total score summarizes the impact of COPD on overall patient's health status.
  • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
  • The scale is continuous.
  • Rate of decline shows the yearly change of SGRQ total score.
Month 30
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 36
Time Frame: Month 36
  • SGRQ total score summarizes the impact of COPD on overall patient's health status.
  • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
  • The scale is continuous.
  • Rate of decline shows the yearly change of SGRQ total score.
Month 36
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 42
Time Frame: Month 42
  • SGRQ total score summarizes the impact of COPD on overall patient's health status.
  • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
  • The scale is continuous.
  • Rate of decline shows the yearly change of SGRQ total score.
Month 42
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 48
Time Frame: Month 48
  • SGRQ total score summarizes the impact of COPD on overall patient's health status.
  • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
  • The scale is continuous.
  • Rate of decline shows the yearly change of SGRQ total score.
Month 48
Number and Percentage of Participants With All Cause Death and Time to Event Analysis (On-treatment)
Time Frame: Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days
On-treatment defined as day 1 to completion of double blinded treatment plus 30 days
Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days
Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1470 Days)
Time Frame: Day 1 to day 1470
All cause mortality vital status information was followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used.
Day 1 to day 1470
Number and Percentage of Participants With Lower Respiratory Death (On-treatment; Adjudicated Primary Cause)
Time Frame: Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days
The primary cause of death was adjudicated by an external committee prior to unblinding; on-treatment defined as day 1 to completion of double blinded treatment plus 30 days
Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days
Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days)
Time Frame: Day 1 to day 1470
The primary cause of death was adjudicated by an external committee prior to unblinding; vital status was information followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used
Day 1 to day 1470

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence Rate of Serious Adverse Event (System Organ Class = Cardiac Disorders)
Time Frame: Day 1 to completion of double blinded treatment plus 30 days
Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.
Day 1 to completion of double blinded treatment plus 30 days
Incidence Rate of Serious Adverse Event (Preferred Term = Angina)
Time Frame: Day 1 to completion of double blinded treatment plus 30 days
Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.
Day 1 to completion of double blinded treatment plus 30 days
Incidence Rate of Serious Adverse Event (Preferred Term = Atrial Fibrillation)
Time Frame: Day 1 to completion of double blinded treatment plus 30 days
Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.
Day 1 to completion of double blinded treatment plus 30 days
Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure)
Time Frame: Day 1 to completion of double blinded treatment plus 30 days
Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.
Day 1 to completion of double blinded treatment plus 30 days
Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure Congestive)
Time Frame: Day 1 to completion of double blinded treatment plus 30 days
Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.
Day 1 to completion of double blinded treatment plus 30 days
Incidence Rate of Serious Adverse Event (Preferred Term = Coronary Artery Disease)
Time Frame: Day 1 to completion of double blinded treatment plus 30 days
Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.
Day 1 to completion of double blinded treatment plus 30 days
Incidence Rate of Serious Adverse Event (Preferred Term = Myocardial Infarction)
Time Frame: Day 1 to completion of double blinded treatment plus 30 days
Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.
Day 1 to completion of double blinded treatment plus 30 days
Incidence Rate of Serious Adverse Event (System Organ Class = Lower Respiratory System Disorders)
Time Frame: Day 1 to completion of double blinded treatment plus 30 days
Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.
Day 1 to completion of double blinded treatment plus 30 days
Incidence Rate of Serious Adverse Event (Preferred Term = Bronchitis)
Time Frame: Day 1 to completion of double blinded treatment plus 30 days
Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.
Day 1 to completion of double blinded treatment plus 30 days
Incidence Rate of Serious Adverse Event (Preferred Term = Chronic Obstructive Pulmonary Disease (COPD) Exacerbation)
Time Frame: Day 1 to completion of double blinded treatment plus 30 days
Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.
Day 1 to completion of double blinded treatment plus 30 days
Incidence Rate of Serious Adverse Event (Preferred Term = Dyspnoea)
Time Frame: Day 1 to completion of double blinded treatment plus 30 days
Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.
Day 1 to completion of double blinded treatment plus 30 days
Incidence Rate of Serious Adverse Event (Preferred Term = Pneumonia)
Time Frame: Day 1 to completion of double blinded treatment plus 30 days
Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.
Day 1 to completion of double blinded treatment plus 30 days
Incidence Rate of Serious Adverse Event (Preferred Term = Respiratory Failure)
Time Frame: Day 1 to completion of double blinded treatment plus 30 days
Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.
Day 1 to completion of double blinded treatment plus 30 days

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

December 1, 2002

Primary Completion (Actual)

February 1, 2008

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (Estimate)

September 5, 2005

Study Record Updates

Last Update Posted (Estimate)

May 20, 2014

Last Update Submitted That Met QC Criteria

May 15, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205.235

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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