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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00974805
Acronym
IMAS
Enrollment
48
Registered
2009-09-10
Start date
2010-02-28
Completion date
2012-02-29
Last updated
2014-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, Emphysema, Bronchitis

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.

Interventions

DRUGSeretide 500 Accuhaler

Seretide 500 accuhaler one inhalation BD

Sponsors

GlaxoSmithKline
CollaboratorINDUSTRY
University of Southampton
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
The primary outcome measures are change in cell type and activation status56 days

Secondary

MeasureTime frame
Change in sputum and serum cytokines Change in bacterial colonization56 days

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026