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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

Seretide 500 Accuhaler

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Emphysema, Bronchitis

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Southampton General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Seretide 500 Accuhaler

Arm Description

Seretide 500 Accuhaler one inhalation BD

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in sputum and serum cytokines Change in bacterial colonization

Full Information

NCT ID

NCT00974805

First Posted

September 8, 2009

Last Updated

December 5, 2014

Sponsor

University of Southampton

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00974805

Brief Title

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

Acronym

IMAS

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 Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Southampton

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

COPD, Emphysema, Bronchitis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Seretide 500 Accuhaler

Arm Type

Experimental

Arm Description

Seretide 500 Accuhaler one inhalation BD

Intervention Type

Drug

Intervention Name(s)

Seretide 500 Accuhaler

Intervention Description

Seretide 500 accuhaler one inhalation BD

Primary Outcome Measure Information:

Title

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

Time Frame

56 days

Secondary Outcome Measure Information:

Title

Change in sputum and serum cytokines Change in bacterial colonization

Time Frame

56 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Southampton General Hospital

City

Southampton

State/Province

Hampshire

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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