An Investigation of the Mechanism of Action of Seretide in Chronic Obstructive Pulmonary Disease (IMAS)
|ClinicalTrials.gov Identifier: NCT00974805|
Recruitment Status : Completed
First Posted : September 10, 2009
Last Update Posted : December 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Drug: Seretide 500 Accuhaler||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Experimental: Seretide 500 Accuhaler
Seretide 500 Accuhaler one inhalation BD
Drug: Seretide 500 Accuhaler
Seretide 500 accuhaler one inhalation BD
- The primary outcome measures are change in cell type and activation status [ Time Frame: 56 days ]
- Change in sputum and serum cytokines Change in bacterial colonization [ Time Frame: 56 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974805
|Southampton General Hospital|
|Southampton, Hampshire, United Kingdom, SO16 6YD|