Status:
COMPLETED
Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE4
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 continuousl...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male or female aged 40 years or more
- Severe to very severe chronic obstructive pulmonary disease (COPD)
- Current or ex-smoker with smoking history of at least 10 pack years
- At least one documented exacerbation of COPD in previous year
- Exclusion criteria:
- Significant diseases other than COPD; significant alcohol or drug abuse
- Current clinical diagnosis of asthma requiring steroid treatment
- History of thoracotomy with pulmonary resection
- Regular use of daytime oxygen
- Recent history (within 3 months) of myocardial infarction
- Recent (within 6 weeks) respiratory infection or COPD exacerbation
- Recent (within 6 weeks) treatment with systemic corticosteroids at doses in excess of 5milligram / day
- Recent (within 3 months) unstable or life-threatening cardiac arrhythmia requiring intervention
- Recent (within 1 year) hospitalisation for cardiac failure
- Malignancy requiring chemotherapy or radiotherapy
- Clinical diagnosis of bronchiectasis
- Pregnant or nursing women
- Known hypersensitivity to study drugs
- Current or recent (within 30 days) participation in another clinical study
- Current participation in or recent completion (within 4 weeks) of a pulmonary rehabilitation program
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
2488 Patients enrolled
Trial Details
Trial ID
NCT00975195
Start Date
February 1 2009
End Date
July 1 2013
Last Update
February 10 2015
Active Locations (222)
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1
352.2046.61006 Boehringer Ingelheim Investigational Site
Concord, New South Wales, Australia
2
352.2046.61001 Boehringer Ingelheim Investigational Site
Glebe, New South Wales, Australia
3
352.2046.61002 Boehringer Ingelheim Investigational Site
Westmead, New South Wales, Australia
4
352.2046.61004 Boehringer Ingelheim Investigational Site
Daw Park, South Australia, Australia