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An Investigation of the Mechanism of Action of Seretide in Chronic Obstructive Pulmonary Disease (IMAS)
This study is not yet open for participant recruitment.
Study NCT00974805   Information provided by University of Southampton
First Received: September 8, 2009   Last Updated: September 9, 2009   History of Changes

September 8, 2009
September 9, 2009
February 2010
February 2012   (final data collection date for primary outcome measure)
The primary outcome measures are change in cell type and activation status [ Time Frame: 56 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00974805 on ClinicalTrials.gov Archive Site
Change in sputum and serum cytokines Change in bacterial colonization [ Time Frame: 56 days ] [ Designated as safety issue: No ]
Same as current
 
An Investigation of the Mechanism of Action of Seretide in Chronic Obstructive Pulmonary Disease
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

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.

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.

Phase IV
Interventional
Allocation:  Non-Randomized
Control:  Uncontrolled
Endpoint Classification:  Pharmacodynamics Study
Intervention Model:  Single Group Assignment
Masking:  Open Label
Primary Purpose:  Basic Science
Chronic Obstructive Pulmonary Disease
Drug: Seretide 500 Accuhaler
Seretide 500 accuhaler one inhalation BD
Seretide 500 Accuhaler: Experimental
Seretide 500 Accuhaler one inhalation BD
Intervention: Drug: Seretide 500 Accuhaler
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Not yet recruiting
48
February 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • >35yrs.
  • >10 Pack Years COPD as defined as an FEV1<70% and an FEV1/FVC ratio of <70%

Exclusion Criteria:

  • Asthma
  • Lung cancer
  • Bronchiectasis
Both
35 Years to 80 Years
Yes
Contact: Simon C Bourne, MB BS, DM, MRCP(UK) +442380798781 simon@soton.ac.uk
United Kingdom
 
NCT00974805
Southampton General Hospital, NHS
SCB-001
University of Southampton
GlaxoSmithKline
 
University of Southampton
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP