An Investigation of the Mechanism of Action of Seretide in 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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Bronchial Diseases Bronchitis Chronic Disease Disease Attributes Emphysema Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Southampton General Hospital

Southampton, Hampshire, SO16 6YD, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Seretide 500 Accuhaler

Drug

Seretide 500 accuhaler one inhalation BD

Primary outcomes

The primary outcome measures are change in cell type and activation status

Time frame: 56 days

Secondary outcomes

Change in sputum and serum cytokines Change in bacterial colonization

Time frame: 56 days

Sponsors and collaborators

Lead sponsor

University of Southampton

Other

Collaborators

GlaxoSmithKline

Registry information

Official study 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

Acronym: IMAS

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Sep 10, 2009
Registry last updated: Dec 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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