Randomised placebo controlled trial of low dose prednisolone for 3-years in subjects with chronic obstructive pulmonary disease with a sputum eosinophilia - Randomised trial of long term prednisolone in COPD with eosinophilia
Phase 1
- Conditions
- Chronic obstructive pulmonary disease with sputum eosinophilia>3%
- Registration Number
- EUCTR2005-002138-36-GB
- Lead Sponsor
- niversity Hospital of Leicester NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
Subjects will be >45yrs old and have COPD FEV1<80% predicted, FEV1/FVC<70%, <15% bronchodilator reversibility.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Subjects with significant co-morbidity will be excluded including: bronchiectasis, lung cancer, heart failure, osteoporosis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To reduce decline in lung function & rate of annual exacerbation rate in patients with COPD & sputum eosinophilia on oral prednisolone versus placebo;Secondary Objective: To observe safety issues of long term low dose oral prednisolone, visual analogue scores for respiratory symptoms;Primary end point(s): Primary outcomes<br>1.Lung function Post-bronchodilator FEV1<br>2.Exacerbations-Moderate 7severe<br><br>
- Secondary Outcome Measures
Name Time Method