An Investigation of the Mechanism of Action of Seretide in Chronic Obstructive Pulmonary Disease - Full Text View

Sponsor:	University of Southampton
Collaborator:	GlaxoSmithKline
Information provided by:	University of Southampton
ClinicalTrials.gov Identifier:	NCT00974805

Purpose

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.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: Seretide 500 Accuhaler	Phase IV

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study
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

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Advair

U.S. FDA Resources

Further study details as provided by University of Southampton:

Primary Outcome Measures:

The primary outcome measures are change in cell type and activation status [ Time Frame: 56 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in sputum and serum cytokines Change in bacterial colonization [ Time Frame: 56 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	February 2010
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Seretide 500 Accuhaler: Experimental Seretide 500 Accuhaler one inhalation BD	Drug: Seretide 500 Accuhaler Seretide 500 accuhaler one inhalation BD

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

Ages Eligible for Study:	35 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974805

Contacts

Contact: Simon C Bourne, MB BS, DM, MRCP(UK)

+442380798781

simon@soton.ac.uk

Locations

United Kingdom, Hampshire
Southampton General Hospital
Southampton, Hampshire, United Kingdom, SO16 6YD

Sponsors and Collaborators

University of Southampton

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	NHS ( Southampton General Hospital )
Study ID Numbers:	SCB-001
Study First Received:	September 8, 2009
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00974805 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Southampton:

COPD
Emphysema
Bronchitis

Additional relevant MeSH terms:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on February 08, 2010