Budesonide / Formoterol in Treatment of Exacerbations of COPD
Phase 2
Completed
- Conditions
- Chronic Obstructive Pulmonary Disease
- Registration Number
- NCT00239278
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to determine whether the budesonide+formoterol combination is effective in the treatment of exacerbations of COPD with a main emphasis on investigating the effects on inflammation and a secondary emphasis on clinical efficacy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- smoking-induced COPD according to ATS criteria
- FEV1 <85% of predicted at enrolment and <70% of predicted but > 0.7 Liter at Exacerbation
- FEV1/IVC ratio <88% of predicted for men and <89% for women
Exclusion Criteria
- history of asthma
- known hypersensitivity to the study drugs
- serious concomitant diseases
- pregnancy or lactating
- abnormal Chest X-ray or blood gasses
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Eosinophils in induced sputum (as % of Total Cell Count), change from the start of the exacerbation to the end of 14 days treatment
- Secondary Outcome Measures
Name Time Method Inflammatory markers in induced sputum, blood/serum and urine Lung function tests at clinic Diary cards for PEF and symptoms Patient Related outcomes Questioning for Adverse Events and in blood: routine tests and cortisol
Trial Locations
- Locations (1)
Research Site
🇳🇱Groningen, Netherlands