Clinical trial NCT00387088: Tiotropium / Respimat One Year Study in COPD.
Official title: Efficacy {FEV1, COPD Exacerbations & HRQoL} & Safety of 5mcg Tiotropium Respimat in COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-10-12
Enrollment: 3991
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337
timeFrame: Baseline and Day 337
measure: Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
timeFrame: During actual study treatment period (planned Day 1 to Day 337)
Secondary outcomes:
measure: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29
timeFrame: Baseline and Day 29
measure: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169
timeFrame: Baseline and Day 169
measure: Number of COPD Exacerbations Per Patient - Exposure Adjusted
timeFrame: During actual study treatment period (planned Day 1 to Day 337)
measure: Number of COPD Exacerbations Per Patient - naïve Estimate
timeFrame: During actual study treatment period (planned Day 1 to Day 337)
measure: Number of Patients With at Least One COPD Exacerbation
timeFrame: During actual study treatment period (planned Day 1 to Day 337)
measure: Time to First Hospitalisation for COPD Exacerbation
timeFrame: During actual study treatment period (planned Day 1 to Day 337)
measure: Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted
timeFrame: During actual study treatment period (planned Day 1 to Day 337)
measure: Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate
timeFrame: During actual study treatment period (planned Day 1 to Day 337)
measure: Number of Patients With at Least One Hospitalisation for a COPD Exacerbation
timeFrame: During actual study treatment period (planned Day 1 to Day 337)
measure: Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 337
timeFrame: Baseline and Day 337
measure: Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 169
timeFrame: Baseline and Day 169
measure: Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 337
timeFrame: Baseline and Day 337
measure: Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 169
timeFrame: Baseline and Day 169
measure: Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 29
timeFrame: Baseline and Day 29
measure: Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 169
timeFrame: Baseline and Day 169
measure: Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 337
timeFrame: Baseline and Day 337
measure: Marked Changes From Baseline in Vital Signs at End of Treatment
timeFrame: Baseline and end of treatment
measure: Clinically Relevant Findings in Physical Examination and ECG
timeFrame: End of treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 205.372.01012 Boehringer Ingelheim Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: 205.372.01020 Boehringer Ingelheim Investigational Site
state: Alabama
city: Mobile
country: United States
facility: 205.372.01062 Boehringer Ingelheim Investigational Site
state: Alabama
city: Berkeley
country: United States
facility: 205.372.01048 Boehringer Ingelheim Investigational Site
state: California
city: Huntington Park
country: United States
facility: 205.372.01037 Boehringer Ingelheim Investigational Site
state: California
city: Long Beach
country: United States
facility: 205.372.01058 Boehringer Ingelheim Investigational Site
state: California
city: Long Beach
country: United States
facility: 205.372.01059 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 205.372.01007 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 205.372.01034 Boehringer Ingelheim Investigational Site
state: California
city: Rancho Mirage
country: United States
facility: 205.372.01028 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 205.372.01011 Boehringer Ingelheim Investigational Site
state: California
city: Boulder
country: United States
facility: 205.372.01066 Boehringer Ingelheim Investigational Site
state: Colorado
city: Norwalk
country: United States
facility: 205.372.01008 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Brandon
country: United States
facility: 205.372.01004 Boehringer Ingelheim Investigational Site
state: Florida
city: Clearwater
country: United States
facility: 205.372.01060 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami Beach
country: United States
facility: 205.372.01069 Boehringer Ingelheim Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: 205.372.01023 Boehringer Ingelheim Investigational Site
state: Florida
city: Winter Park
country: United States
facility: 205.372.01053 Boehringer Ingelheim Investigational Site
state: Florida
city: Calhoun
country: United States
facility: 205.372.01045 Boehringer Ingelheim Investigational Site
state: Georgia
city: Normal
country: United States
facility: 205.372.01043 Boehringer Ingelheim Investigational Site
state: Illinois
city: Dubuque
country: United States
facility: 205.372.01061 Boehringer Ingelheim Investigational Site
state: Iowa
city: Wichita
country: United States
facility: 205.372.01035 Boehringer Ingelheim Investigational Site
state: Kansas
city: Shreveport
country: United States
facility: 205.372.01049 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Biddeford
country: United States
facility: 205.372.01015 Boehringer Ingelheim Investigational Site
state: Maine
city: Columbia
country: United States
facility: 205.372.01067 Boehringer Ingelheim Investigational Site
state: Maryland
city: Rockville
country: United States
facility: 205.372.01006 Boehringer Ingelheim Investigational Site
state: Maryland
city: Detroit
country: United States
facility: 205.372.01013 Boehringer Ingelheim Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: 205.372.01003 Boehringer Ingelheim Investigational Site
state: Minnesota
city: Chesterfield
country: United States
facility: 205.372.01021 Boehringer Ingelheim Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: 205.372.01014 Boehringer Ingelheim Investigational Site
state: Missouri
city: Omaha
country: United States
facility: 205.372.01036 Boehringer Ingelheim Investigational Site
state: Nebraska
city: Albuquerque
country: United States
facility: 205.372.01046 Boehringer Ingelheim Investigational Site
state: New Mexico
city: Mineola
country: United States
facility: 205.372.01024 Boehringer Ingelheim Investigational Site
state: New York
city: Rochester
country: United States
facility: 205.372.01029 Boehringer Ingelheim Investigational Site
state: New York
city: Syracuse
country: United States
facility: 205.372.01030 Boehringer Ingelheim Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: 205.372.01026 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: 205.372.01019 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Elizabeth City
country: United States
facility: 205.372.01027 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: 205.372.01038 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: 205.372.01031 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: 205.372.01017 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: 205.372.01041 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: 205.372.01044 Boehringer Ingelheim Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: 205.372.01001 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: 205.372.01063 Boehringer Ingelheim Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: 205.372.01068 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Swathmore
country: United States
facility: 205.372.01056 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Dallas
country: United States
facility: 205.372.01039 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 205.372.01050 Boehringer Ingelheim Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: 205.372.01005 Boehringer Ingelheim Investigational Site
state: Texas
city: Killeen
country: United States
facility: 205.372.01018 Boehringer Ingelheim Investigational Site
state: Texas
city: New Braunfels
country: United States
facility: 205.372.01040 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 205.372.01052 Boehringer Ingelheim Investigational Site
state: Texas
city: Danville
country: United States
facility: 205.372.01022 Boehringer Ingelheim Investigational Site
state: Virginia
city: Lynchburg
country: United States
facility: 205.372.01065 Boehringer Ingelheim Investigational Site
state: Virginia
city: Richmond
country: United States
facility: 205.372.01055 Boehringer Ingelheim Investigational Site
state: Virginia
city: Tacoma
country: United States
facility: 205.372.01064 Boehringer Ingelheim Investigational Site
state: Washington
city: Glebe
country: Australia
facility: 205.372.61002 Woolcock Institute of Medical Research
state: New South Wales
city: Cairns
country: Australia
facility: 205.372.61009 Thoracic & General Physician
state: Queensland
city: Redcliffe
country: Australia
facility: 205.372.61005 Redcliffe Hospital
state: Queensland
city: Port Lincoln
country: Australia
facility: 205.372.61006 The Investigator Clinic
state: South Australia
city: Toorak Gardens
country: Australia
facility: 205.372.61007 The Burnside War Memorial Hospital
state: South Australia
city: Woodville
country: Australia
facility: 205.372.61004 Boehringer Ingelheim Investigational Site
state: South Australia
city: Box Hill
country: Australia
facility: 205.372.61010 Ecru
state: Victoria
city: Geelong
country: Australia
facility: 205.372.61008 Geelong Clinical Research Centre
state: Victoria
city: Malvern
country: Australia
facility: 205.372.61001 Emeritus Research
state: Victoria
city: Nedlands
country: Australia
facility: 205.372.61003 Sir Charles Gairdner Hospital
state: Western Australia
city: Florianópolis
country: Brazil
facility: 205.372.55012 Universidade Federal de Santa Catarina
city: Goiânia
country: Brazil
facility: 205.372.55009 Hospital das Clínicas de Goiânia
city: Recife
country: Brazil
facility: 205.372.55005 Hospital Geral Otávio de Freitas
city: São Paulo - SP
country: Brazil
facility: 205.372.55001 INCOR e Hospital das Clínicas da Universidade de São Paulo
city: São Paulo - SP
country: Brazil
facility: 205.372.55010 Unidade de Coracao e Pulmao do Dto. de Medicina
city: Vitória
country: Brazil
facility: 205.372.55011 CEDOES - Diagnóstico e Pesquisa
city: Calgary
country: Canada
facility: 205.372.11007 Heritage Medical Research Building
state: Alberta
city: Calgary
country: Canada
facility: 205.372.11013 Calgary West Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: 205.372.11011 Hermitage Medicentre
state: Alberta
city: Edmonton
country: Canada
facility: 205.372.11017 Boehringer Ingelheim Investigational Site
state: Alberta
city: Wetaskiwin
country: Canada
facility: 205.372.11020 Wetaskiwin Lung Laboratory
state: Alberta
city: Chilliwack
country: Canada
facility: 205.372.11010 Dr. Kay Ho
state: British Columbia
city: Vancouver
country: Canada
facility: 205.372.11018 Pacific Lung Health Centre
state: British Columbia
city: Saint John
country: Canada
facility: 205.372.11005 Professional Corp. Respirology
state: New Brunswick
city: St. John's
country: Canada
facility: 205.372.11009 White Hills Medical Clinic
state: Newfoundland and Labrador
city: Grimsby
country: Canada
facility: 205.372.11012 West Lincoln Memorial Hospital
state: Ontario
city: London
country: Canada
facility: 205.372.11014 Dr. Robert Luton
state: Ontario
city: Niagara Falls
country: Canada
facility: 205.372.11001 Niagara Clinical Research
state: Ontario
city: Ottawa
country: Canada
facility: 205.372.11019 Allergy and Asthma Research Centre
state: Ontario
city: Sarnia
country: Canada
facility: 205.372.11003 London Road Diagnostic Clinic and Medical Centre
state: Ontario
city: Sarnia
country: Canada
facility: 205.372.11016 London Road Diagnostic Clinic and Medical Centre
state: Ontario
city: Scarborough
country: Canada
facility: 205.372.11002 Centenary Respiratory Research Associates
state: Ontario
city: La Malbaie
country: Canada
facility: 205.372.11006 Clinique de médecine familiale de La Malbaie
state: Quebec
city: Saskatoon
country: Canada
facility: 205.372.11004 Mount Royal Family Physicians
state: Saskatchewan
city: Saskatoon
country: Canada
facility: 205.372.11015 Dr. Arun Nayar
state: Saskatchewan
city: Beijing
country: China
facility: 205.372.86002 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 205.372.86003 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 205.372.86004 Boehringer Ingelheim Investigational Site
city: Chengdu, Sichuan Province
country: China
facility: 205.372.86009 Boehringer Ingelheim Investigational Site
city: Chongqing
country: China
facility: 205.372.86008 Boehringer Ingelheim Investigational Site
city: Guangzhou
country: China
facility: 205.372.86001 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 205.372.86010 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 205.372.86011 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 205.372.86012 Boehringer Ingelheim Investigational Site
city: Shenyang
country: China
facility: 205.372.86005 Boehringer Ingelheim Investigational Site
city: Shenyang
country: China
facility: 205.372.86006 Boehringer Ingelheim Investigational Site
city: Wuhan
country: China
facility: 205.372.86007 Boehringer Ingelheim Investigational Site
city: Aarhus C
country: Denmark
facility: 205.372.45004 Boehringer Ingelheim Investigational Site
city: Horsens
country: Denmark
facility: 205.372.45005 Boehringer Ingelheim Investigational Site
city: Hvidovre
country: Denmark
facility: 205.372.45002 Boehringer Ingelheim Investigational Site
city: København NV
country: Denmark
facility: 205.372.45001 Boehringer Ingelheim Investigational Site
city: Odense C
country: Denmark
facility: 205.372.45003 Boehringer Ingelheim Investigational Site
city: Silkeborg
country: Denmark
facility: 205.372.45006 Boehringer Ingelheim Investigational Site
city: Helsinki
country: Finland
facility: 205.372.35804 Boehringer Ingelheim Investigational Site
city: Jyväskylä
country: Finland
facility: 205.372.35802 Boehringer Ingelheim Investigational Site
city: Lahti
country: Finland
facility: 205.372.35803 Boehringer Ingelheim Investigational Site
city: Tampere
country: Finland
facility: 205.372.35801 Boehringer Ingelheim Investigational Site
city: Castelnau le Lez
country: France
facility: 205.372.3318A Clinique du Parc
city: Castelnau le Lez
country: France
facility: 205.372.3318B Clinique du Parc
city: Chamalières
country: France
facility: 205.372.3304A Cabinet Médical
city: Clermont Ferrand cedex 1
country: France
facility: 205.372.3301A Hôpital Gabriel Montpied
city: Denain
country: France
facility: 205.372.3310A Centre Hospitalier
city: Grasse
country: France
facility: 205.372.3314A Cabinet Médical
city: Marseille
country: France
facility: 205.372.3306A Hôpital Ambroise Paré
city: Metz cedex 1
country: France
facility: 205.372.3303A Hôpital Notre Dame de Bon Secours
city: Metz cedex 1
country: France
facility: 205.372.3303B Hôpital Notre Dame de Bon Secours
city: Montigny les Metz
country: France
facility: 205.372.3312A Cabinet Médical
city: Montigny les Metz
country: France
facility: 205.372.3312B Cabinet Médical
city: Nantes
country: France
facility: 205.372.3302A Centre Médical Erdre Saint Augustin
city: Nice
country: France
facility: 205.372.3305A Cabinet Médical
city: Nice
country: France
facility: 205.372.3305B Cabinet Médical
city: Nimes cedex 9
country: France
facility: 205.372.3315B Hôpital Caremeau
city: Nîmes
country: France
facility: 205.372.3315A Hôpital Caremeau
city: Nîmes
country: France
facility: 205.372.3317A Cabinet de Pneumologie
city: Ollioules
country: France
facility: 205.372.3320A Polyclinique Les Fleurs
city: Ollioules
country: France
facility: 205.372.3320B Polyclinique Les Fleurs
city: Reims
country: France
facility: 205.372.3316A Clinique les Bleuets
city: Reims
country: France
facility: 205.372.3316B Clinique les Bleuets
city: Saint Laurent du Var
country: France
facility: 205.372.3319A Institut Arnault Tzanck
city: Six Four les Plages
country: France
facility: 205.372.3325A Cabinet Médical
city: St Gaudens
country: France
facility: 205.372.3321A Centre Hospitalier
city: St Gaudens
country: France
facility: 205.372.3321C Centre Hospitalier
city: Toulon
country: France
facility: 205.372.3324A Cabinet Médical
city: Toulouse
country: France
facility: 205.372.3309A Cabinet médical
city: Toulouse
country: France
facility: 205.372.3309B Cabinet médical
city: Berlin
country: Germany
facility: 205.372.49002 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 205.372.49004 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 205.372.49013 Boehringer Ingelheim Investigational Site
city: Bonn
country: Germany
facility: 205.372.49007 Boehringer Ingelheim Investigational Site
city: Bruchsal
country: Germany
facility: 205.372.49008 Boehringer Ingelheim Investigational Site
city: Frankfurt/Main
country: Germany
facility: 205.372.49011 Boehringer Ingelheim Investigational Site
city: Gelnhausen
country: Germany
facility: 205.372.49012 Boehringer Ingelheim Investigational Site
city: Gütersloh
country: Germany
facility: 205.372.49006 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 205.372.49014 Boehringer Ingelheim Investigational Site
city: Kassel
country: Germany
facility: 205.372.49005 Boehringer Ingelheim Investigational Site
city: Minden
country: Germany
facility: 205.372.49009 Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: 205.372.49010 Boehringer Ingelheim Investigational Site
city: Weinheim
country: Germany
facility: 205.372.49016 Boehringer Ingelheim Investigational Site
city: Weyhe
country: Germany
facility: 205.372.49015 Boehringer Ingelheim Investigational Site
city: Wiesloch
country: Germany
facility: 205.372.49001 Boehringer Ingelheim Investigational Site
city: Witten
country: Germany
facility: 205.372.49003 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 205.372.30001 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 205.372.30002 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 205.372.30003 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 205.372.30013 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 205.372.30015 Boehringer Ingelheim Investigational Site
city: Heraklion-Crete
country: Greece
facility: 205.372.30009 Boehringer Ingelheim Investigational Site
city: Kalamaria
country: Greece
facility: 205.372.30007 Boehringer Ingelheim Investigational Site
city: Kavala
country: Greece
facility: 205.372.30005 Boehringer Ingelheim Investigational Site
city: Komotini
country: Greece
facility: 205.372.30004 Boehringer Ingelheim Investigational Site
city: Korinthos
country: Greece
facility: 205.372.30011 Boehringer Ingelheim Investigational Site
city: Nafplio
country: Greece
facility: 205.372.30019 Boehringer Ingelheim Investigational Site
city: Serres
country: Greece
facility: 205.372.30008 Boehringer Ingelheim Investigational Site
city: Thessaloniki
country: Greece
facility: 205.372.30006 Boehringer Ingelheim Investigational Site
city: Thessaloniki
country: Greece
facility: 205.372.30017 Boehringer Ingelheim Investigational Site
city: Thiva
country: Greece
facility: 205.372.30014 Boehringer Ingelheim Investigational Site
city: Hong Kong
country: Hong Kong
facility: 205.372.85203 Boehringer Ingelheim Investigational Site
city: Kowloon
country: Hong Kong
facility: 205.372.85201 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 205.372.36001 Boehringer Ingelheim Investigational Site
city: Debrecen
country: Hungary
facility: 205.372.36002 Boehringer Ingelheim Investigational Site
city: Deszk
country: Hungary
facility: 205.372.36004 Boehringer Ingelheim Investigational Site
city: Erd
country: Hungary
facility: 205.372.36005 Boehringer Ingelheim Investigational Site
city: Mosonmagyarovar
country: Hungary
facility: 205.372.36006 Boehringer Ingelheim Investigational Site
city: Sopron
country: Hungary
facility: 205.372.36007 Boehringer Ingelheim Investigational Site
city: Andhra Pradesh
country: India
facility: 205.372.91005 Boehringer Ingelheim Investigational Site
city: Andhra Pradesh
country: India
facility: 205.372.91016 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 205.372.91003 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 205.372.91006 Boehringer Ingelheim Investigational Site
city: Calicut,Kerala
country: India
facility: 205.372.91017 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 205.372.91007 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 205.372.91010 Boehringer Ingelheim Investigational Site
city: Coimbatore
country: India
facility: 205.372.91002 Boehringer Ingelheim Investigational Site
city: Gujarat
country: India
facility: 205.372.91009 Boehringer Ingelheim Investigational Site
city: indore,MP
country: India
facility: 205.372.91011 Boehringer Ingelheim Investigational Site
city: Maharashtra
country: India
facility: 205.372.91012 Boehringer Ingelheim Investigational Site
city: Mumbai
country: India
facility: 205.372.91004 Boehringer Ingelheim Investigational Site
city: Mumbai
country: India
facility: 205.372.91008 Boehringer Ingelheim Investigational Site
city: New Delhi
country: India
facility: 205.372.91015 Boehringer Ingelheim Investigational Site
city: Punjab
country: India
facility: 205.372.91014 Boehringer Ingelheim Investigational Site
city: Tamil Nadu
country: India
facility: 205.372.91013 Boehringer Ingelheim Investigational Site
city: Uttar Pradesh
country: India
facility: 205.372.91001 Boehringer Ingelheim Investigational Site
city: Mullingar
country: Ireland
facility: 205.372.35303 Boehringer Ingelheim Investigational Site
city: Bussolengo (vr)
country: Italy
facility: 205.372.39007 Boehringer Ingelheim Investigational Site
city: Ferrara
country: Italy
facility: 205.372.39012 Boehringer Ingelheim Investigational Site
city: Genova
country: Italy
facility: 205.372.39003 Boehringer Ingelheim Investigational Site
city: Genova
country: Italy
facility: 205.372.39004 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 205.372.39005 Boehringer Ingelheim Investigational Site
city: Modena
country: Italy
facility: 205.372.39008 Boehringer Ingelheim Investigational Site
city: Orbassano (to)
country: Italy
facility: 205.372.39009 Boehringer Ingelheim Investigational Site
city: Pisa
country: Italy
facility: 205.372.39001 Boehringer Ingelheim Investigational Site
city: Pordenone
country: Italy
facility: 205.372.39010 Boehringer Ingelheim Investigational Site
city: Prato (fi)
country: Italy
facility: 205.372.39002 Boehringer Ingelheim Investigational Site
city: Roma
country: Italy
facility: 205.372.39011 Boehringer Ingelheim Investigational Site
city: Trieste
country: Italy
facility: 205.372.39006 Boehringer Ingelheim Investigational Site
city: Anyang
country: Korea, Republic of
facility: 205.372.82010 Boehringer Ingelheim Investigational Site
city: Daegu
country: Korea, Republic of
facility: 205.372.82005 Boehringer Ingelheim Investigational Site
city: Daejoen
country: Korea, Republic of
facility: 205.372.82009 Boehringer Ingelheim Investigational Site
city: Incheon
country: Korea, Republic of
facility: 205.372.82003 Boehringer Ingelheim Investigational Site
city: Jeonbuk
country: Korea, Republic of
facility: 205.372.82008 Boehringer Ingelheim Investigational Site
city: Kwangju
country: Korea, Republic of
facility: 205.372.82007 Boehringer Ingelheim Investigational Site
city: Pusan
country: Korea, Republic of
facility: 205.372.82002 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 205.372.82001 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 205.372.82004 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 205.372.82006 Boehringer Ingelheim Investigational Site
city: Kaunas
country: Lithuania
facility: 205.372.37001 Boehringer Ingelheim Investigational Site
city: Kaunas
country: Lithuania
facility: 205.372.37003 Boehringer Ingelheim Investigational Site
city: Vilnius
country: Lithuania
facility: 205.372.37002 Boehringer Ingelheim Investigational Site
city: Johor Baharu
country: Malaysia
facility: 205.372.60007 Boehringer Ingelheim Investigational Site
city: Kelantan Darul Naim
country: Malaysia
facility: 205.372.60004 Boehringer Ingelheim Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: 205.372.60005 Boehringer Ingelheim Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: 205.372.60006 Boehringer Ingelheim Investigational Site
city: Kuching, Sarawak
country: Malaysia
facility: 205.372.60002 Boehringer Ingelheim Investigational Site
city: Penang
country: Malaysia
facility: 205.372.60003 Boehringer Ingelheim Investigational Site
city: Selangor
country: Malaysia
facility: 205.372.60001 Boehringer Ingelheim Investigational Site
city: Chihuahua
country: Mexico
facility: 205.372.52018 Hospital Universitario de Chihuahua
city: Col. Seccion XVI
country: Mexico
facility: 205.372.52017 Instituto Nacional de Enfermedades Respiratorias (INER)
city: Cuernavaca, Mor. México
country: Mexico
facility: 205.372.52013 Sanatorio Henri Dunant
city: Guadalajara Jal.
country: Mexico
facility: 205.372.52009 Hospital Civil Antiguo
city: Guadalajara
country: Mexico
facility: 205.372.52005 Hospital Civil Nuevo de Guadalajara
city: Hermosillo, Sonora
country: Mexico
facility: 205.372.52001 Hospital General del Estado de Sonora
city: Huixquilucan Edo.Mex.
country: Mexico
facility: 205.372.52014 Hospital Angeles de las Lomas
city: Merida Yuc.
country: Mexico
facility: 205.372.52004 Clínica de Mérida
city: Mexicali Baja California Norte
country: Mexico
facility: 205.372.52016 Hospital General de Mexicali
city: Monterrey, Nuevo León
country: Mexico
facility: 205.372.52002 Unidad de Investigación clínica en Medicina
city: Monterrey, Nuevo León
country: Mexico
facility: 205.372.52006 Hospital Universitario
city: Mérida Yucatán
country: Mexico
facility: 205.372.52010 Hospital General Agustin O´Haran
city: San Luis Potosi
country: Mexico
facility: 205.372.52012 Hospital de Nuestra Señora de la Salud
city: Zapopan, Jal.
country: Mexico
facility: 205.372.52003 Hospital "Angel Leaño"
city: Amsterdam
country: Netherlands
facility: 205.372.31009 Boehringer Ingelheim Investigational Site
city: Drachten
country: Netherlands
facility: 205.372.31006 Boehringer Ingelheim Investigational Site
city: Groningen
country: Netherlands
facility: 205.372.31001 Boehringer Ingelheim Investigational Site
city: Hoofddorp
country: Netherlands
facility: 205.372.31011 Boehringer Ingelheim Investigational Site
city: Leeuwarden
country: Netherlands
facility: 205.372.31007 Boehringer Ingelheim Investigational Site
city: Roosendaal
country: Netherlands
facility: 205.372.31004 Boehringer Ingelheim Investigational Site
city: Sneek
country: Netherlands
facility: 205.372.31003 Boehringer Ingelheim Investigational Site
city: Utrecht
country: Netherlands
facility: 205.372.31012 Boehringer Ingelheim Investigational Site
city: Voorburg
country: Netherlands
facility: 205.372.31002 Boehringer Ingelheim Investigational Site
city: Weerselo
country: Netherlands
facility: 205.372.31008 Boehringer Ingelheim Investigational Site
city: Winschoten
country: Netherlands
facility: 205.372.31005 Boehringer Ingelheim Investigational Site
city: Sandvika
country: Norway
facility: 205.372.47001 Boehringer Ingelheim Investigational Site
city: Trondheim
country: Norway
facility: 205.372.47003 Boehringer Ingelheim Investigational Site
city: Ålesund
country: Norway
facility: 205.372.47002 Boehringer Ingelheim Investigational Site
city: Amadora
country: Portugal
facility: 205.372.35102 Hospital Fernando Fonseca
city: Lisboa
country: Portugal
facility: 205.372.35101 Hospital Pulido Valente
city: Lisboa
country: Portugal
facility: 205.372.35104 Hospital de Santa Marta
city: Porto
country: Portugal
facility: 205.372.35103 Hospital de São João
city: Viana do Castelo
country: Portugal
facility: 205.372.35105 Centro Hospitalar do Alto Minho, Estrada de Santa Luzia
city: Singapore
country: Singapore
facility: 205.372.65001 Boehringer Ingelheim Investigational Site
city: Singapore
country: Singapore
facility: 205.372.65003 Boehringer Ingelheim Investigational Site
city: Singapore
country: Singapore
facility: 205.372.65005 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 205.372.42102 Boehringer Ingelheim Investigational Site
city: Nove Zamky
country: Slovakia
facility: 205.372.42103 Boehringer Ingelheim Investigational Site
city: Bellville
country: South Africa
facility: 205.372.27002 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 205.372.27001 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 205.372.27004 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 205.372.27008 Boehringer Ingelheim Investigational Site
city: Centurion
country: South Africa
facility: 205.372.27006 Boehringer Ingelheim Investigational Site
city: Durban
country: South Africa
facility: 205.372.27003 Boehringer Ingelheim Investigational Site
city: Pretoria
country: South Africa
facility: 205.372.27005 Boehringer Ingelheim Investigational Site
city: Somerset West
country: South Africa
facility: 205.372.27007 Boehringer Ingelheim Investigational Site
city: Cáceres
country: Spain
facility: 205.372.34005 Hospital San Pedro de Alcántara
city: Madrid
country: Spain
facility: 205.372.34004 Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: 205.372.34006 Hospital 12 de octubre
city: Terrassa (Barcelona)
country: Spain
facility: 205.372.34001 Hospital Mutua Terrassa
city: Valencia
country: Spain
facility: 205.372.34002 Hospital Universitario Dr. Peset
city: Boden
country: Sweden
facility: 205.372.46001 Björknäs Vårdcentral
city: Höllviken
country: Sweden
facility: 205.372.46004 Näsets läkargrupp
city: Linköping
country: Sweden
facility: 205.372.46005 Lungmedicinska kliniken
city: Stockholm
country: Sweden
facility: 205.372.46006 Lungmedicinska Kliniken
city: Sundsvall
country: Sweden
facility: 205.372.46002 Alnö Vårdcentral
city: Lugano
country: Switzerland
facility: 205.372.41002 Boehringer Ingelheim Investigational Site
city: Montana
country: Switzerland
facility: 205.372.41003 Boehringer Ingelheim Investigational Site
city: Zürich
country: Switzerland
facility: 205.372.41001 Boehringer Ingelheim Investigational Site
city: Kaohsiung
country: Taiwan
facility: 205.372.88607 Kaohsiung Medical University Hospital
city: Tainan
country: Taiwan
facility: 205.372.88606 National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: 205.372.88601 National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: 205.372.88602 Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: 205.372.88603 Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: 205.372.88604 Tri-Service General Hospital
city: Taipei
country: Taiwan
facility: 205.372.88608 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 205.372.88609 Boehringer Ingelheim Investigational Site
city: Taoyuan
country: Taiwan
facility: 205.372.88605 Chang Gung Memorial Hosp-Linkou
city: Ankara
country: Turkey
facility: 205.372.90006 Gazi Universitesi Tip Fakultesi Gogus Hastaliklari A.B.D.
city: Ankara
country: Turkey
facility: 205.372.90007 Atatürk Gög. Hastaliklari ve Cerrahisi Egitim Hastanesi
city: Bursa
country: Turkey
facility: 205.372.90003 Uludag Universitesi Tip Fakultesi Gogus Hastaliklari
city: Edirne
country: Turkey
facility: 205.372.90009 Trakya Universitesi Tip Fakultesi Gogus Hastaliklari A.B.D.
city: Istanbul
country: Turkey
facility: 205.372.90004 Dr. Lütfi Kirdar Egitim ve Arastirma Hastanesi
city: Istanbul
country: Turkey
facility: 205.372.90005 Istanbul Universitesi Cerrahpasa Tip Fakultesi
city: Izmir
country: Turkey
facility: 205.372.90001 Izmir Tepecik Gogus Hastaliklari ve Gogus Cerrahisi Hast.
city: Kayseri
country: Turkey
facility: 205.372.90008 Erciyes Universitesi Tip Fakultesi
city: Konya
country: Turkey
facility: 205.372.90010 Selcuk Universitesi Tip Fakultesi
city: Samsun
country: Turkey
facility: 205.372.90002 19 Mayis Universitesi Tip Fakultesi Gogus Hastaliklari A.B.D
city: Aston Clinton, Aylesbury
country: United Kingdom
facility: 205.372.44027 Boehringer Ingelheim Investigational Site
city: Carmarthen
country: United Kingdom
facility: 205.372.44022 Boehringer Ingelheim Investigational Site
city: Chertsey
country: United Kingdom
facility: 205.372.44002 Boehringer Ingelheim Investigational Site
city: Chesterfield
country: United Kingdom
facility: 205.372.44023 Boehringer Ingelheim Investigational Site
city: Darlington
country: United Kingdom
facility: 205.372.44014 Boehringer Ingelheim Investigational Site
city: East Horsley
country: United Kingdom
facility: 205.372.44009 Boehringer Ingelheim Investigational Site
city: Fowey
country: United Kingdom
facility: 205.372.44011 Boehringer Ingelheim Investigational Site
city: Frome
country: United Kingdom
facility: 205.372.44003 Boehringer Ingelheim Investigational Site
city: Greenisland
country: United Kingdom
facility: 205.372.44026 Boehringer Ingelheim Investigational Site
city: Heywood
country: United Kingdom
facility: 205.372.44013 Boehringer Ingelheim Investigational Site
city: Isleworth
country: United Kingdom
facility: 205.372.44016 Boehringer Ingelheim Investigational Site
city: Kirkby in Ashfield
country: United Kingdom
facility: 205.372.44020 Boehringer Ingelheim Investigational Site
city: Mortimer
country: United Kingdom
facility: 205.372.44024 Boehringer Ingelheim Investigational Site
city: Nottingham
country: United Kingdom
facility: 205.372.44001 Boehringer Ingelheim Investigational Site
city: Penzance
country: United Kingdom
facility: 205.372.44018 Boehringer Ingelheim Investigational Site
city: Plymouth
country: United Kingdom
facility: 205.372.44021 Boehringer Ingelheim Investigational Site
city: Sheffield
country: United Kingdom
facility: 205.372.44007 Boehringer Ingelheim Investigational Site
city: Sneinton, Nottingham
country: United Kingdom
facility: 205.372.44010 Boehringer Ingelheim Investigational Site
city: St Just, Penzance
country: United Kingdom
facility: 205.372.44005 Boehringer Ingelheim Investigational Site
city: St. Austell
country: United Kingdom
facility: 205.372.44015 Boehringer Ingelheim Investigational Site
city: Sunderland
country: United Kingdom
facility: 205.372.44006 Boehringer Ingelheim Investigational Site
city: Wellingborough
country: United Kingdom
facility: 205.372.44008 Boehringer Ingelheim Investigational Site
city: Westbury on Trym
country: United Kingdom
facility: 205.372.44012 Boehringer Ingelheim Investigational Site
city: Windsor
country: United Kingdom
facility: 205.372.44028 Boehringer Ingelheim Investigational Site
city: Woking
country: United Kingdom
facility: 205.372.44019 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.
citation: Bateman ED, Tashkin D, Siafakas N, Dahl R, Towse L, Massey D, Pavia D, Zhong NS. A one-year trial of tiotropium Respimat plus usual therapy in COPD patients. Respir Med. 2010 Oct;104(10):1460-72. doi: 10.1016/j.rmed.2010.06.004.