The effect of inhaled corticosteroids (ICS) on airway inflammation in chronic obstructive pulmonary disease (COPD)
Completed
- Conditions
- chronic obstructive pulmonary disease (COPD)Respiratory - Chronic obstructive pulmonary disease
- Registration Number
- ACTRN12612001111864
- Lead Sponsor
- GlaxoSmithKline's (GSK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
FEV1/FVC < 70% post bronchodilator and no other major co-morbidities
Exclusion Criteria
Major confounding co-morbidities, steroids therapy in last 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Airway inflammatory cells and structural changes in bronchial biopsies from COPD patients before and after 6 months of treatment. <br>Airway inflammation was assessed by immuno-staining bronchial biopsies from COPD patients for different inflammatory markers. In recent work we are addressing structural changes in airways by looking at epithelial activation in COPD.[at 6 months]
- Secondary Outcome Measures
Name Time Method Clinical activity of COPD patients was assessed after 6 months on treatment. <br>Subjects completed a Quality of Life questionnaire (St Georges Respiratory Questionnaire, SGRQ) at baseline and following the treatment period. They also recorded daily symptoms of breathlessness, sputum expectoration, cough and salbutamol use in a diary card, during the run-in and throughout the treatment period. Symptom scores were averaged over 14 days and baseline values were compared with those at the end of treatment. All subjects returned for review every two months, at which time diary cards were checked, spirometry repeated, compliance with study medication checked and the subjects were asked about any exacerbations.[at 6 months]