An Investigation of the Mechanism of Action of Seretide in Chronic Obstructive Pulmonary Disease (IMAS)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Southampton
ClinicalTrials.gov Identifier:
NCT00974805
First received: September 8, 2009
Last updated: December 5, 2014
Last verified: December 2014

September 8, 2009
December 5, 2014
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
Not Provided
Not Provided
 
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.

Interventional
Phase 4
Allocation: Non-Randomized
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
Experimental: Seretide 500 Accuhaler
Seretide 500 Accuhaler one inhalation BD
Intervention: Drug: Seretide 500 Accuhaler
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00974805
SCB-001
Yes
Not Provided
Not Provided
University of Southampton
University of Southampton
GlaxoSmithKline
Not Provided
University of Southampton
December 2014

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