An Investigation of the Mechanism of Action of Seretide in Chronic Obstructive Pulmonary Disease
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: Seretide 500 Accuhaler
- Registration Number
- NCT00974805
- Lead Sponsor
- University of Southampton
- Brief Summary
This study is investigating the possible mechanisms of action of an inhaled treatment (Seretide), currently used worldwide in millions of patients with COPD (Chronic Obstructive Pulmonary Disease) and how it improves the symptoms of these patients. Previous research has failed to identify the mechanisms at play other than dilation of the airways. The research community has long thought the mechanism to be immune based or anti inflammatory but despite intensive research this has not yet been identified.
- Detailed Description
We aim to recruit equal numbers of healthy smokers, mild, moderate and severe COPD patients (12 patients to be recruited from each group). These patients will never have been prescribed the components present in Seretide (Salmeterol and Flixotide or similar compounds).
The patients will have spirometry at the beginning of the study to confirm the presence of COPD. Healthy smokers will defined as ex or current smokers who match the study population but have normal lung function.
Patients with a history of asthma, bronchiectasis, carcinoma of the bronchus, or other significant respiratory disease will be excluded.
The patients will have a total of four study visits, 2 off treatment and 2 while on treatment, over a 56 day study period. At each study visit induced sputum will be performed and blood extracted. The cells fom both of these samples will be analysed for cells type and activation. Sputum and serum will be stored for cytokine analysis at a later date.
The Sputum will be induced using standardised protocols using nebulised saline solution.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- >35yrs.
- >10 Pack Years COPD as defined as an FEV1<70% and an FEV1/FVC ratio of <70%
- Asthma
- Lung cancer
- Bronchiectasis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Seretide 500 Accuhaler Seretide 500 Accuhaler Seretide 500 Accuhaler one inhalation BD
- Primary Outcome Measures
Name Time Method The primary outcome measures are change in cell type and activation status 56 days
- Secondary Outcome Measures
Name Time Method Change in sputum and serum cytokines Change in bacterial colonization 56 days
Trial Locations
- Locations (1)
Southampton General Hospital
🇬🇧Southampton, Hampshire, United Kingdom