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

NCT ID: NCT00974805

Last Updated: 2014-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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COPD Emphysema Bronchitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Seretide 500 Accuhaler

Seretide 500 Accuhaler one inhalation BD

Group Type EXPERIMENTAL

Seretide 500 Accuhaler

Intervention Type DRUG

Seretide 500 accuhaler one inhalation BD

Interventions

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Seretide 500 Accuhaler

Seretide 500 accuhaler one inhalation BD

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

University of Southampton

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Southampton General Hospital

Southampton, Hampshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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SCB-001

Identifier Type: -

Identifier Source: org_study_id