Tiotropium / Respimat One Year Study in COPD.

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00387088
• Other study ID #: 205.372
• Secondary ID: 2006-001009-27
• Status: Completed
• Phase: Phase 3
• First received: October 11, 2006
• Last updated: May 7, 2014
• Start date: September 2006

Study information

• Verified date: September 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Responsilble Ethics CommitteeBrazil: Ministry of HealthCanada: Health Canada - Therapeutic Products DirectorateChina: Food and Drug AdministrationDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyFrance: AFSSAPSGermany: BfArM Bundesinstitut fuer Arzneimittel und MedizinprodukteGreat Britain: MHRAGreece: National Organization for Medicines (EOF) National Ethics CommitteeHong Kong: Department of HealthHungary: National Institute of Pharmacy, H-1051 BudapestIndia: Ministry of Health and Family WelfareIreland: Irish Medicines BoardItaly: Comitato Etico dell'Azienda Osp. Universitaria Pisana - PISAKorea, Republic of: Korea Food and Drug Administration (KFDA)Lithuania: State Medicines Control Agency, LT-01132 VilniusMalaysia: Ministry of HealthMexico: Ministry of HealthNetherlands: Central Committee on Research Involving Human Subjects (CCMO)Norway: Norwegian Medicines Agency (Statens Legemiddelverk)Portugal: National Pharmacy and Medicines InstituteSingapore: Health Sciences Authority,Ministry of HealthSlovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26South Africa: Medicines Control CouncilSpain: Ministry of HealthSweden: The National Board of Health and WelfareSwitzerland: Swissmedic, Hallerstrasse 7, 3000 BernTaiwan: Department of Health, Executive Yuan, TaiwanTurkey: Ministry of Health Central Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3991
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Respimat

Drug:
• Tiotropium

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  China,  Denmark,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Ireland,  Italy,  Korea, Republic of,  Lithuania,  Malaysia,  Mexico,  Netherlands,  Norway,  Portugal,  Singapore,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at 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	No
Primary	Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation	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)	No
Secondary	Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at 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	No
Secondary	Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at 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	No
Secondary	Number of COPD Exacerbations Per Patient - Exposure Adjusted	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)	No
Secondary	Number of COPD Exacerbations Per Patient - naïve Estimate	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)	No
Secondary	Number of Patients With at Least One COPD Exacerbation	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)	No
Secondary	Time to First Hospitalisation for COPD Exacerbation	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)	No
Secondary	Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted	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)	No
Secondary	Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate	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)	No
Secondary	Number of Patients With at Least One Hospitalisation for a COPD Exacerbation	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)	No
Secondary	Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at 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	No
Secondary	Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at 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	No
Secondary	Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at 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	No
Secondary	Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at 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	No
Secondary	Change From Baseline in Trough Forced Vital Capacity (FVC) at 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	No
Secondary	Change From Baseline in Trough Forced Vital Capacity (FVC) at 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	No
Secondary	Change From Baseline in Trough Forced Vital Capacity (FVC) at 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	No
Secondary	Marked Changes From Baseline in Vital Signs at 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	No
Secondary	Clinically Relevant Findings in Physical Examination and ECG	Clinically relevant findings in Physical Examination and ECG at end of treatment	End of treatment	No

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