An Investigation of the Mechanism of Action of Seretide in Chronic Obstructive Pulmonary Disease (IMAS)
Recruitment status was Not yet recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | September 8, 2009 | ||||
| Last Updated Date | September 9, 2009 | ||||
| Start Date ICMJE | February 2010 | ||||
| Estimated Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The primary outcome measures are change in cell type and activation status [ Time Frame: 56 days ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00974805 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Change in sputum and serum cytokines Change in bacterial colonization [ Time Frame: 56 days ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | An Investigation of the Mechanism of Action of Seretide in Chronic Obstructive Pulmonary Disease | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE | Chronic Obstructive Pulmonary Disease | ||||
| Intervention ICMJE | Drug: Seretide 500 Accuhaler
Seretide 500 accuhaler one inhalation BD |
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| Study Arm (s) | Experimental: Seretide 500 Accuhaler
Seretide 500 Accuhaler one inhalation BD
Intervention: Drug: Seretide 500 Accuhaler |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 48 | ||||
| Estimated Completion Date | February 2012 | ||||
| Estimated Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 35 Years to 80 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00974805 | ||||
| Other Study ID Numbers ICMJE | SCB-001 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Southampton General Hospital, NHS | ||||
| Study Sponsor ICMJE | University of Southampton | ||||
| Collaborators ICMJE | GlaxoSmithKline | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | University of Southampton | ||||
| Verification Date | September 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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