Chronic Obstructive Pulmonary Disease Clinical Trial
— IMASOfficial 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
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | February 2012 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 35 Years to 80 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United Kingdom | Southampton General Hospital | Southampton | Hampshire |
Lead Sponsor | Collaborator |
---|---|
University of Southampton | GlaxoSmithKline |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome measures are change in cell type and activation status | 56 days | No | |
Secondary | Change in sputum and serum cytokines Change in bacterial colonization | 56 days | No |
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