Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease
Tracking Information
Start Date ICMJE | February 2009 |
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Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: September 10, 2009) | The primary efficacy endpoint is time to first COPD exacerbation. [ Time Frame: 48 weeks ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00975195 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: September 10, 2009) | Breathlessness, exercise endurance, health related quality of life Number and severity of COPD exacerbations Changes in inflammatory markers [ Time Frame: 48 weeks ] |
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease |
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Official Title ICMJE | Inhaled Corticosteroid Withdrawal Study |
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. |
Detailed Description | |
Study Phase | Phase IV |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Pulmonary Disease, Chronic Obstructive |
Intervention ICMJE |
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Recruitment Information
Estimated Enrollment ICMJE | 2192 | ||||
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Completion Date | |||||
Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 40 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Australia, Belgium, Brazil, Bulgaria, China, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, New Zealand, Philippines, Poland, Russian Federation, South Africa, Spain, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00975195 | ||||
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Responsible Party | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim | ||||
Study ID Numbers ICMJE | 352.2046, EUDRACT2007-002522-29 | ||||
Study Sponsor ICMJE | Boehringer Ingelheim Pharmaceuticals | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Boehringer Ingelheim Pharmaceuticals |
Source: http://clinicaltrials.gov/