Clinical trial NCT00975195: Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease
Official title: A Randomised, Double-blind, Active-controlled Study to Evaluate the Impact of Stepwise Withdrawal of Inhaled Corticosteroid Treatment in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD) on Optimized Bronchodilator Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-09-11
Enrollment: 2488
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomised study to be conducted in patients with severe to very severe Chronic Obstructive Pulmonary Disease (COPD) to establish whether there is a need for these patients to be continuously treated with an inhaled corticosteroid on top of two potent long-acting bronchodilators. The study also aims to identify the type of patients who are likely to benefit from inhaled corticosteroid maintenance therapy.


Eligibility criteria: Inclusion criteria:

1. Male or female aged 40 years or more
2. Severe to very severe chronic obstructive pulmonary disease (COPD)
3. Current or ex-smoker with smoking history of at least 10 pack years
4. At least one documented exacerbation of COPD in previous year

Exclusion criteria:

1. Significant diseases other than COPD; significant alcohol or drug abuse
2. Current clinical diagnosis of asthma requiring steroid treatment
3. History of thoracotomy with pulmonary resection
4. Regular use of daytime oxygen
5. Recent history (within 3 months) of myocardial infarction
6. Recent (within 6 weeks) respiratory infection or COPD exacerbation
7. Recent (within 6 weeks) treatment with systemic corticosteroids at doses in excess of 5milligram / day
8. Recent (within 3 months) unstable or life-threatening cardiac arrhythmia requiring intervention
9. Recent (within 1 year) hospitalisation for cardiac failure
10. Malignancy requiring chemotherapy or radiotherapy
11. Clinical diagnosis of bronchiectasis
12. Pregnant or nursing women
13. Known hypersensitivity to study drugs
14. Current or recent (within 30 days) participation in another clinical study
15. Current participation in or recent completion (within 4 weeks) of a pulmonary rehabilitation program

Primary outcomes:
measure: Time to First Moderate or Severe On-treatment COPD Exacerbation
timeFrame: During randomised treatment, up to 488 days
Secondary outcomes:
measure: Number of Moderate or Severe On-treatment COPD Exacerbations
timeFrame: During randomised treatment, up to 488 days
measure: Proportion of Patients With ≥1 Moderate or Severe On-treatment COPD Exacerbation
timeFrame: During randomised treatment, up to 488 days
measure: Time to First Severe On-treatment COPD Exacerbation
timeFrame: During randomised treatment, up to 488 days
measure: Number of Severe On-treatment COPD Exacerbations
timeFrame: During randomised treatment, up to 488 days
measure: Proportion of Patients With at Least One Severe On-treatment COPD Exacerbation.
timeFrame: During randomised treatment, up to 488 days
measure: Time to First On-treatment COPD Exacerbation
timeFrame: During randomised treatment, up to 488 days
measure: Number of On-treatment COPD Exacerbations
timeFrame: During randomised treatment, up to 488 days
measure: Proportion of Patients With at Least One On-treatment COPD Exacerbation
timeFrame: During randomised treatment, up to 488 days
measure: Severity of On-treatment COPD Exacerbations
timeFrame: During randomised treatment, up to 488 days
measure: Change in On-treatment Lung Function as Measured by Trough FEV1
timeFrame: Baseline and week 6, 12, 18 and 52 visits
measure: Changes in On-treatment Dyspnoea as Measured by the Modified Medical Research Council (MMRC) Dyspnoea Scale
timeFrame: Baseline and week 18 and 52 visits
measure: Change in On-treatment Physical Health Status as Determined by Body Mass Index (BMI)
timeFrame: Baseline and week 18 and 52 visits
measure: Change in On-treatment Exercise Capacity Measured by Six-minute Walk Test (6-MWT)
timeFrame: Baseline and week 18 and 52 visits
measure: Change in On-treatment BODE Index
timeFrame: Baseline and week 18 and 52 visits
measure: Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Impact Domain
timeFrame: Baseline and week 12, 18 and 52 visits
measure: Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Symptoms Domain
timeFrame: Baseline and week 12, 18 and 52 visits
measure: Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Impact Domain
timeFrame: Baseline and week 12, 18 and 52 visits
measure: Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Symptoms Domain
timeFrame: Baseline and week 12, 18 and 52 visits
measure: Change in On-treatment FEV1 as Measured by Home Based Spirometry
timeFrame: Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
measure: Change in On-treatment FVC as Measured by Home Based Spirometry
timeFrame: Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
measure: Change in On-treatment PEFR as Measured by Home Based Spirometry
timeFrame: Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
measure: Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Activity Domain
timeFrame: Baseline and week 27 and 52 visits
measure: Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Impact Domain
timeFrame: Baseline and week 27 and 52 visits
measure: Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Symptoms Domain
timeFrame: Baseline and week 27 and 52 visits
measure: Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Total Score
timeFrame: Baseline and week 27 and 52 visits
measure: Change in On-treatment Physician Global Evaluation
timeFrame: Baseline and week 27 and 52 visits
Other outcomes:
Locations:
city: Concord
country: Australia
facility: 352.2046.61006 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Glebe
country: Australia
facility: 352.2046.61001 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Westmead
country: Australia
facility: 352.2046.61002 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Daw Park
country: Australia
facility: 352.2046.61004 Boehringer Ingelheim Investigational Site
state: South Australia
city: Toorak Gardens
country: Australia
facility: 352.2046.61003 Boehringer Ingelheim Investigational Site
state: South Australia
city: Woodville
country: Australia
facility: 352.2046.61005 Boehringer Ingelheim Investigational Site
state: South Australia
city: Bruxelles
country: Belgium
facility: 352.2046.32002 Boehringer Ingelheim Investigational Site
city: Bruxelles
country: Belgium
facility: 352.2046.32016 Boehringer Ingelheim Investigational Site
city: Eupen
country: Belgium
facility: 352.2046.32015 Boehringer Ingelheim Investigational Site
city: Gilly
country: Belgium
facility: 352.2046.32017 Boehringer Ingelheim Investigational Site
city: Herentals
country: Belgium
facility: 352.2046.32014 Boehringer Ingelheim Investigational Site
city: Jambes
country: Belgium
facility: 352.2046.32006 Boehringer Ingelheim Investigational Site
city: Lebbeke
country: Belgium
facility: 352.2046.32008 Boehringer Ingelheim Investigational Site
city: Leuven
country: Belgium
facility: 352.2046.32001 Boehringer Ingelheim Investigational Site
city: Middelheim
country: Belgium
facility: 352.2046.32004 Boehringer Ingelheim Investigational Site
city: Montigny-le-Tilleul
country: Belgium
facility: 352.2046.32010 Boehringer Ingelheim Investigational Site
city: Turnhout
country: Belgium
facility: 352.2046.32013 Boehringer Ingelheim Investigational Site
city: Goiania
country: Brazil
facility: 352.2046.55005 Boehringer Ingelheim Investigational Site
city: Goiânia
country: Brazil
facility: 352.2046.55002 Boehringer Ingelheim Investigational Site
city: Porto Alegre
country: Brazil
facility: 352.2046.55001 Boehringer Ingelheim Investigational Site
city: Porto Alegre
country: Brazil
facility: 352.2046.55006 Boehringer Ingelheim Investigational Site
city: Sao Paulo
country: Brazil
facility: 352.2046.55003 Boehringer Ingelheim Investigational Site
city: Bourgas
country: Bulgaria
facility: 352.2046.35905 Boehringer Ingelheim Investigational Site
city: Rousse
country: Bulgaria
facility: 352.2046.35902 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 352.2046.35904 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 352.2046.35906 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 352.2046.35907 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 352.2046.35908 Boehringer Ingelheim Investigational Site
city: Stara Zagora
country: Bulgaria
facility: 352.2046.35903 Boehringer Ingelheim Investigational Site
city: Veliko Tarnovo
country: Bulgaria
facility: 352.2046.35909 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 352.2046.86002 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 352.2046.86003 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 352.2046.86006 Boehringer Ingelheim Investigational Site
city: Chongqing
country: China
facility: 352.2046.86008 Boehringer Ingelheim Investigational Site
city: Guangzhou
country: China
facility: 352.2046.86001 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 352.2046.86004 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 352.2046.86005 Boehringer Ingelheim Investigational Site
city: Wuhan
country: China
facility: 352.2046.86007 Boehringer Ingelheim Investigational Site
city: Aarhus C
country: Denmark
facility: 352.2046.45001 Boehringer Ingelheim Investigational Site
city: København NV
country: Denmark
facility: 352.2046.45003 Boehringer Ingelheim Investigational Site
city: Odense C
country: Denmark
facility: 352.2046.45002 Boehringer Ingelheim Investigational Site
city: Brest
country: France
facility: 352.2046.3317A Boehringer Ingelheim Investigational Site
city: Brest
country: France
facility: 352.2046.3317B Boehringer Ingelheim Investigational Site
city: Brest
country: France
facility: 352.2046.3317C Boehringer Ingelheim Investigational Site
city: Castelnau le Lez
country: France
facility: 352.2046.3320A Boehringer Ingelheim Investigational Site
city: Castelnau le Lez
country: France
facility: 352.2046.3320B Boehringer Ingelheim Investigational Site
city: Castelnau le Lez
country: France
facility: 352.2046.3320C Boehringer Ingelheim Investigational Site
city: Clermont Ferrand cedex 1
country: France
facility: 352.2046.3335A Boehringer Ingelheim Investigational Site
city: Forbach
country: France
facility: 352.2046.3314A Boehringer Ingelheim Investigational Site
city: Marseille cedex 20
country: France
facility: 352.2046.3301A Boehringer Ingelheim Investigational Site
city: Marseille
country: France
facility: 352.2046.3333A Boehringer Ingelheim Investigational Site
city: Montpellier
country: France
facility: 352.2046.3326A Boehringer Ingelheim Investigational Site
city: Montpellier
country: France
facility: 352.2046.3326C Boehringer Ingelheim Investigational Site
city: Nantes Cedex 1
country: France
facility: 352.2046.3325A Boehringer Ingelheim Investigational Site
city: Nantes Cedex 1
country: France
facility: 352.2046.3325C Boehringer Ingelheim Investigational Site
city: Nantes Cedex 1
country: France
facility: 352.2046.3325D Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 352.2046.3334A Boehringer Ingelheim Investigational Site
city: Nîmes
country: France
facility: 352.2046.3324A Boehringer Ingelheim Investigational Site
city: Nîmes
country: France
facility: 352.2046.3332A Boehringer Ingelheim Investigational Site
city: Nîmes
country: France
facility: 352.2046.3332B Boehringer Ingelheim Investigational Site
city: Nîmes
country: France
facility: 352.2046.3332C Boehringer Ingelheim Investigational Site
city: Perpignan
country: France
facility: 352.2046.3331A Boehringer Ingelheim Investigational Site
city: Perpignan
country: France
facility: 352.2046.3331B Boehringer Ingelheim Investigational Site
city: Perpignan
country: France
facility: 352.2046.3331C Boehringer Ingelheim Investigational Site
city: Saint Laurent du Var
country: France
facility: 352.2046.3329A Boehringer Ingelheim Investigational Site
city: Saint Laurent du Var
country: France
facility: 352.2046.3329B Boehringer Ingelheim Investigational Site
city: Saint-Pierre cedex
country: France
facility: 352.2046.3302A Boehringer Ingelheim Investigational Site
city: Saint-Pierre cedex
country: France
facility: 352.2046.3302B Boehringer Ingelheim Investigational Site
city: Saint-Pierre cedex
country: France
facility: 352.2046.3302C Boehringer Ingelheim Investigational Site
city: Saint-Pierre cedex
country: France
facility: 352.2046.3302D Boehringer Ingelheim Investigational Site
city: Toulouse cedex 9
country: France
facility: 352.2046.3336A Boehringer Ingelheim Investigational Site
city: Toulouse cedex 9
country: France
facility: 352.2046.3336B Boehringer Ingelheim Investigational Site
city: Toulouse cedex 9
country: France
facility: 352.2046.3336C Boehringer Ingelheim Investigational Site
city: Toulouse
country: France
facility: 352.2046.3337A Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 352.2046.49012 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 352.2046.49020 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 352.2046.49021 Boehringer Ingelheim Investigational Site
city: Bochum
country: Germany
facility: 352.2046.49008 Boehringer Ingelheim Investigational Site
city: Cottbus
country: Germany
facility: 352.2046.49019 Boehringer Ingelheim Investigational Site
city: Donaustauf
country: Germany
facility: 352.2046.49002 Boehringer Ingelheim Investigational Site
city: Frankfurt/Main
country: Germany
facility: 352.2046.49023 Boehringer Ingelheim Investigational Site
city: Frankfurt
country: Germany
facility: 352.2046.49013 Boehringer Ingelheim Investigational Site
city: Frankfurt
country: Germany
facility: 352.2046.49025 Boehringer Ingelheim Investigational Site
city: Geesthacht
country: Germany
facility: 352.2046.49024 Boehringer Ingelheim Investigational Site
city: Gelnhausen
country: Germany
facility: 352.2046.49022 Boehringer Ingelheim Investigational Site
city: Großhansdorf
country: Germany
facility: 352.2046.49001 Boehringer Ingelheim Investigational Site
city: Heidelberg
country: Germany
facility: 352.2046.49006 Boehringer Ingelheim Investigational Site
city: Immenhausen
country: Germany
facility: 352.2046.49014 Boehringer Ingelheim Investigational Site
city: Kiel
country: Germany
facility: 352.2046.49016 Boehringer Ingelheim Investigational Site
city: Köln
country: Germany
facility: 352.2046.49003 Boehringer Ingelheim Investigational Site
city: Mainz
country: Germany
facility: 352.2046.49004 Boehringer Ingelheim Investigational Site
city: Marburg
country: Germany
facility: 352.2046.49005 Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: 352.2046.49015 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 352.2046.30003 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 352.2046.30004 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 352.2046.30005 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 352.2046.30007 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 352.2046.30008 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 352.2046.30011 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 352.2046.30012 Boehringer Ingelheim Investigational Site
city: Heraklion
country: Greece
facility: 352.2046.30006 Boehringer Ingelheim Investigational Site
city: Larisa
country: Greece
facility: 352.2046.30009 Boehringer Ingelheim Investigational Site
city: Thessaloniki
country: Greece
facility: 352.2046.30001 Boehringer Ingelheim Investigational Site
city: Thessaloniki
country: Greece
facility: 352.2046.30002 Boehringer Ingelheim Investigational Site
city: Cegled
country: Hungary
facility: 352.2046.36003 Boehringer Ingelheim Investigational Site
city: Deszk
country: Hungary
facility: 352.2046.36002 Boehringer Ingelheim Investigational Site
city: Komarom
country: Hungary
facility: 352.2046.36004 Boehringer Ingelheim Investigational Site
city: Pecs
country: Hungary
facility: 352.2046.36006 Boehringer Ingelheim Investigational Site
city: Szarvas
country: Hungary
facility: 352.2046.36001 Boehringer Ingelheim Investigational Site
city: Szazhalombatta
country: Hungary
facility: 352.2046.36005 Boehringer Ingelheim Investigational Site
city: Szigetszentmiklos
country: Hungary
facility: 352.2046.36011 Boehringer Ingelheim Investigational Site
city: Catania
country: Italy
facility: 352.2046.39002 Boehringer Ingelheim Investigational Site
city: Cona
country: Italy
facility: 352.2046.39007 Boehringer Ingelheim Investigational Site
city: Foggia
country: Italy
facility: 352.2046.39005 Boehringer Ingelheim Investigational Site
city: Modena
country: Italy
facility: 352.2046.39003 Boehringer Ingelheim Investigational Site
city: Montescano (pv)
country: Italy
facility: 352.2046.39006 Boehringer Ingelheim Investigational Site
city: Pisa
country: Italy
facility: 352.2046.39001 Boehringer Ingelheim Investigational Site
city: Sesto S. Giovanni (mi)
country: Italy
facility: 352.2046.39004 Boehringer Ingelheim Investigational Site
city: Tradate (va)
country: Italy
facility: 352.2046.39008 Boehringer Ingelheim Investigational Site
city: Heerlen
country: Netherlands
facility: 352.2046.31004 Boehringer Ingelheim Investigational Site
city: Leeuwarden
country: Netherlands
facility: 352.2046.31001 Boehringer Ingelheim Investigational Site
city: Rotterdam
country: Netherlands
facility: 352.2046.31003 Boehringer Ingelheim Investigational Site
city: Veldhoven
country: Netherlands
facility: 352.2046.31002 Boehringer Ingelheim Investigational Site
city: Auckland NZ
country: New Zealand
facility: 352.2046.64007 Boehringer Ingelheim Investigational Site
city: Christchurch
country: New Zealand
facility: 352.2046.64003 Boehringer Ingelheim Investigational Site
city: Dunedin
country: New Zealand
facility: 352.2046.64004 Boehringer Ingelheim Investigational Site
city: Hamilton
country: New Zealand
facility: 352.2046.64006 Boehringer Ingelheim Investigational Site
city: Newtown Wellington NZ
country: New Zealand
facility: 352.2046.64001 Boehringer Ingelheim Investigational Site
city: Otahuhu New Zealand
country: New Zealand
facility: 352.2046.64005 Boehringer Ingelheim Investigational Site
city: Tauranga
country: New Zealand
facility: 352.2046.64002 Boehringer Ingelheim Investigational Site
city: Caloocan
country: Philippines
facility: 352.2046.63001 Boehringer Ingelheim Investigational Site
city: Manila
country: Philippines
facility: 352.2046.63003 Boehringer Ingelheim Investigational Site
city: Manila
country: Philippines
facility: 352.2046.63004 Boehringer Ingelheim Investigational Site
city: Muntinlupa
country: Philippines
facility: 352.2046.63009 Boehringer Ingelheim Investigational Site
city: Quezon City
country: Philippines
facility: 352.2046.63006 Boehringer Ingelheim Investigational Site
city: Quezon City
country: Philippines
facility: 352.2046.63008 Boehringer Ingelheim Investigational Site
city: Quezon
country: Philippines
facility: 352.2046.63005 Boehringer Ingelheim Investigational Site
city: Quezon
country: Philippines
facility: 352.2046.63007 Boehringer Ingelheim Investigational Site
city: Bytom
country: Poland
facility: 352.2046.48006 Boehringer Ingelheim Investigational Site
city: Ostrow Wielkopolska
country: Poland
facility: 352.2046.48003 Boehringer Ingelheim Investigational Site
city: Poznan
country: Poland
facility: 352.2046.48001 Boehringer Ingelheim Investigational Site
city: Poznan
country: Poland
facility: 352.2046.48002 Boehringer Ingelheim Investigational Site
city: Rzeszow
country: Poland
facility: 352.2046.48009 Boehringer Ingelheim Investigational Site
city: Tarnowskie Gory
country: Poland
facility: 352.2046.48011 Boehringer Ingelheim Investigational Site
city: Warsaw
country: Poland
facility: 352.2046.48005 Boehringer Ingelheim Investigational Site
city: Wroclaw
country: Poland
facility: 352.2046.48007 Boehringer Ingelheim Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: 352.2046.07011 Boehringer Ingelheim Investigational Site
city: Ivanovo
country: Russian Federation
facility: 352.2046.07006 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 352.2046.07008 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 352.2046.07009 Boehringer Ingelheim Investigational Site
city: Samara
country: Russian Federation
facility: 352.2046.07002 Boehringer Ingelheim Investigational Site
city: Saratov
country: Russian Federation
facility: 352.2046.07003 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 352.2046.07001 Boehringer Ingelheim Investigational Site
city: Yaroslavl
country: Russian Federation
facility: 352.2046.07004 Boehringer Ingelheim Investigational Site
city: Yaroslavl
country: Russian Federation
facility: 352.2046.07005 Boehringer Ingelheim Investigational Site
city: Amanzimtoti
country: South Africa
facility: 352.2046.27006 Boehringer Ingelheim Investigational Site
city: Bellville
country: South Africa
facility: 352.2046.27002 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 352.2046.27001 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 352.2046.27003 Boehringer Ingelheim Investigational Site
city: Pretoria
country: South Africa
facility: 352.2046.27007 Boehringer Ingelheim Investigational Site
city: Somerset West
country: South Africa
facility: 352.2046.27005 Boehringer Ingelheim Investigational Site
city: Tygerberg
country: South Africa
facility: 352.2046.27004 Boehringer Ingelheim Investigational Site
city: Badajoz
country: Spain
facility: 352.2046.34008 Boehringer Ingelheim Investigational Site
city: Barakaldo (Bilbao)
country: Spain
facility: 352.2046.34002 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 352.2046.34001 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 352.2046.34004 Boehringer Ingelheim Investigational Site
city: Hospitalet de Llobregat
country: Spain
facility: 352.2046.34009 Boehringer Ingelheim Investigational Site
city: Palma de Mallorca
country: Spain
facility: 352.2046.34006 Boehringer Ingelheim Investigational Site
city: Pozuelo de Alarcón
country: Spain
facility: 352.2046.34010 Boehringer Ingelheim Investigational Site
city: Salt (Girona)
country: Spain
facility: 352.2046.34013 Boehringer Ingelheim Investigational Site
city: Sevilla
country: Spain
facility: 352.2046.34011 Boehringer Ingelheim Investigational Site
city: Kaohsiung
country: Taiwan
facility: 352.2046.88606 Boehringer Ingelheim Investigational Site
city: Taichung
country: Taiwan
facility: 352.2046.88604 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 352.2046.88601 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 352.2046.88603 Boehringer Ingelheim Investigational Site
city: Taiwan
country: Taiwan
facility: 352.2046.88607 Boehringer Ingelheim Investigational Site
city: Taiwan
country: Taiwan
facility: 352.2046.88608 Boehringer Ingelheim Investigational Site
city: Ariana
country: Tunisia
facility: 352.2046.2161A Boehringer Ingelheim Investigational Site
city: Ariana
country: Tunisia
facility: 352.2046.2162A Boehringer Ingelheim Investigational Site
city: Sfax
country: Tunisia
facility: 352.2046.2165A Boehringer Ingelheim Investigational Site
city: Sousse
country: Tunisia
facility: 352.2046.2164A Boehringer Ingelheim Investigational Site
city: Tunis
country: Tunisia
facility: 352.2046.2163A Boehringer Ingelheim Investigational Site
city: Ankara
country: Turkey
facility: 352.2046.90009 Boehringer Ingelheim Investigational Site
city: Ankara
country: Turkey
facility: 352.2046.90019 Boehringer Ingelheim Investigational Site
city: Bursa
country: Turkey
facility: 352.2046.90016 Boehringer Ingelheim Investigational Site
city: Denizli
country: Turkey
facility: 352.2046.90010 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 352.2046.90003 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 352.2046.90004 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 352.2046.90006 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 352.2046.90008 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 352.2046.90012 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 352.2046.90017 Boehringer Ingelheim Investigational Site
city: Izmir
country: Turkey
facility: 352.2046.90011 Boehringer Ingelheim Investigational Site
city: Izmir
country: Turkey
facility: 352.2046.90014 Boehringer Ingelheim Investigational Site
city: Izmir
country: Turkey
facility: 352.2046.90018 Boehringer Ingelheim Investigational Site
city: Izmit
country: Turkey
facility: 352.2046.90005 Boehringer Ingelheim Investigational Site
city: Kayseri
country: Turkey
facility: 352.2046.90007 Boehringer Ingelheim Investigational Site
city: Mersin
country: Turkey
facility: 352.2046.90001 Boehringer Ingelheim Investigational Site
city: Samsun
country: Turkey
facility: 352.2046.90002 Boehringer Ingelheim Investigational Site
city: Ivano-Frankivsk
country: Ukraine
facility: 352.2046.38007 Boehringer Ingelheim Investigational Site
city: Kharkiv
country: Ukraine
facility: 352.2046.38002 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 352.2046.38003 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 352.2046.38004 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 352.2046.38006 Boehringer Ingelheim Investigational Site
city: Vinnitsa
country: Ukraine
facility: 352.2046.38005 Boehringer Ingelheim Investigational Site
city: Vinnytsya
country: Ukraine
facility: 352.2046.38001 Boehringer Ingelheim Investigational Site
city: Baillieston, Glasgow
country: United Kingdom
facility: 352.2046.44008 Boehringer Ingelheim Investigational Site
city: Barnsley
country: United Kingdom
facility: 352.2046.44009 Boehringer Ingelheim Investigational Site
city: Belfast
country: United Kingdom
facility: 352.2046.44018 Boehringer Ingelheim Investigational Site
city: Birmingham
country: United Kingdom
facility: 352.2046.44010 Boehringer Ingelheim Investigational Site
city: Cambridge
country: United Kingdom
facility: 352.2046.44003 Boehringer Ingelheim Investigational Site
city: Chertsey
country: United Kingdom
facility: 352.2046.44026 Boehringer Ingelheim Investigational Site
city: Chesterfield
country: United Kingdom
facility: 352.2046.44006 Boehringer Ingelheim Investigational Site
city: Cottingham, Hull
country: United Kingdom
facility: 352.2046.44012 Boehringer Ingelheim Investigational Site
city: Inverness
country: United Kingdom
facility: 352.2046.44028 Boehringer Ingelheim Investigational Site
city: Isleworth
country: United Kingdom
facility: 352.2046.44016 Boehringer Ingelheim Investigational Site
city: Liverpool
country: United Kingdom
facility: 352.2046.44002 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 352.2046.44001 Boehringer Ingelheim Investigational Site
city: Norwich
country: United Kingdom
facility: 352.2046.44017 Boehringer Ingelheim Investigational Site
city: Sheffield
country: United Kingdom
facility: 352.2046.44021 Boehringer Ingelheim Investigational Site
city: Sunderland
country: United Kingdom
facility: 352.2046.44019 Boehringer Ingelheim Investigational Site
city: Windsor
country: United Kingdom
facility: 352.2046.44025 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: Watz H, Tetzlaff K, Magnussen H, Mueller A, Rodriguez-Roisin R, Wouters EFM, Vogelmeier C, Calverley PMA. Spirometric changes during exacerbations of COPD: a post hoc analysis of the WISDOM trial. Respir Res. 2018 Dec 13;19(1):251. doi: 10.1186/s12931-018-0944-3.
citation: Watz H, Tetzlaff K, Wouters EF, Kirsten A, Magnussen H, Rodriguez-Roisin R, Vogelmeier C, Fabbri LM, Chanez P, Dahl R, Disse B, Finnigan H, Calverley PM. Blood eosinophil count and exacerbations in severe chronic obstructive pulmonary disease after withdrawal of inhaled corticosteroids: a post-hoc analysis of the WISDOM trial. Lancet Respir Med. 2016 May;4(5):390-8. doi: 10.1016/S2213-2600(16)00100-4. Epub 2016 Apr 7.
citation: Magnussen H, Disse B, Rodriguez-Roisin R, Kirsten A, Watz H, Tetzlaff K, Towse L, Finnigan H, Dahl R, Decramer M, Chanez P, Wouters EF, Calverley PM; WISDOM Investigators. Withdrawal of inhaled glucocorticoids and exacerbations of COPD. N Engl J Med. 2014 Oct 2;371(14):1285-94. doi: 10.1056/NEJMoa1407154. Epub 2014 Sep 8.