An Investigation of the Mechanism of Action of Seretide in Chronic Obstructive Pulmonary Disease
Information source: University of Southampton
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease
Intervention: Seretide 500 Accuhaler (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: University of Southampton Overall contact:
Simon C Bourne, MB BS, DM, MRCP(UK), Phone: +442380798781, Email: simon@soton.ac.uk
Summary
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.
Clinical Details
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 design: Basic Science, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study
Primary outcome: The primary outcome measures are change in cell type and activation status
Secondary outcome: Change in sputum and serum cytokines
Change in bacterial colonization
Detailed description:
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.
Eligibility
Minimum age: 35 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Simon C Bourne, MB BS, DM, MRCP(UK), Phone: +442380798781, Email: simon@soton.ac.uk
Southampton General Hospital, Southampton, Hampshire SO16 6YD, United Kingdom
Additional Information
Starting date: February 2010
Ending date: February 2012
Last updated: September 9, 2009
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