An Investigation of the Mechanism of Action of Seretide in Chronic Obstructive Pulmonary Disease (IMAS)
Recruitment status was Not yet recruiting
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.
Chronic Obstructive Pulmonary Disease
Drug: Seretide 500 Accuhaler
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||An Investigation Into the Mechanisms of Action of a Combined Long Acting Beta Agonist/Inhaled Corticosteroid (Seretide 500 Accuhaler) on the Bacterial Colonisation, Immunology and Inflammation of Patients With Chronic Obstructive Pulmonary Disease|
- The primary outcome measures are change in cell type and activation status [ Time Frame: 56 days ] [ Designated as safety issue: No ]
- Change in sputum and serum cytokines Change in bacterial colonization [ Time Frame: 56 days ] [ Designated as safety issue: No ]
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||February 2012|
|Estimated Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Experimental: Seretide 500 Accuhaler
Seretide 500 Accuhaler one inhalation BD
Drug: Seretide 500 Accuhaler
Seretide 500 accuhaler one inhalation BD
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974805
|Contact: Simon C Bourne, MB BS, DM, MRCP(UK)||+firstname.lastname@example.org|
|Southampton General Hospital||Not yet recruiting|
|Southampton, Hampshire, United Kingdom, SO16 6YD|
|Contact: Simon C Bourne, MB BS +442380798781 email@example.com|