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临床试验/NCT00974805
NCT00974805已完成4 期

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

University of Southampton1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2010年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
48
试验地点
1
主要终点
The primary outcome measures are change in cell type and activation status

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
35 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >10 Pack Years COPD as defined as an FEV1<70% and an FEV1/FVC ratio of <70%

排除标准

  • Lung cancer
  • Bronchiectasis

研究组 & 干预措施

Seretide 500 Accuhaler

Experimental

Seretide 500 Accuhaler one inhalation BD

干预措施: Seretide 500 Accuhaler (Drug)

结局指标

主要结局

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

时间窗: 56 days

次要结局

  • Change in sputum and serum cytokines Change in bacterial colonization(56 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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