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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by University of Southampton.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Southampton
ClinicalTrials.gov Identifier:
NCT00974805
First received: September 8, 2009
Last updated: September 9, 2009
Last verified: September 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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:


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
Experimental: Seretide 500 Accuhaler
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Southampton General Hospital Not yet recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact: Simon C Bourne, MB BS    +442380798781    simon@soton.ac.uk   
Sponsors and Collaborators
University of Southampton
GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Southampton General Hospital, NHS
ClinicalTrials.gov Identifier: NCT00974805     History of Changes
Other Study ID Numbers: SCB-001
Study First Received: September 8, 2009
Last Updated: September 9, 2009
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
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Fluticasone, salmeterol drug combination
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 20, 2014