A randomised parallel group study to investigate the effect of Seretide withdrawal in COPD using non-invasive biomarkers and physiological measurements - The effect of Seretide withdrawal on lung inflammation in COPD

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: EUCTR2004-003833-15-GB
• Lead Sponsor: South Manchester University NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-02-17
• Study Completion: 2007-08-01
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

Males or females aged 40-75
Ex smokers or current smokers witha cigarette smoking history of more than 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year or equivalent)
Subjects with FEV1 50-80% predicted normal for height, age and sex at screening visit
Subjects with FEV1/FVC ratio <70% at screening visit
Patients taking inhaled Seretide at a dose of 200 - 1000 mcg fluticasone and 50-100 mcg salmeterol per day
Subjects on a stable dose of treatment over the 4 weeks prior to starting the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects taking regular oral leukotriene receptor antagonists, oral corticosteroids, inhaled nasal corticosteroids, oral theophylline or inhaled tiotropium (Spiriva) for the 4 weeks prior to the study start.
Subjects having 1 or more exacerbations of COPD in the past 12 months requiring treatment with oral corticosteroids.
Subjects who have had a previous admission for exacerbation of COPD requiring non-invasive or endotracheal intubation or admission to the intensive care unit.History of asthma or significant atopy/rhinitis (requiring medication)
Subjects with uncontrolled angina, myocardial infarction within the last 12 months or congestive cardiac failure.
Subjects with other significant pulmonary, cardiovascular, neurological, hepatic, renal, endocrine, or haematological diseases as judged by the investigator.
Female subjects who are or intend to become pregnant
Subjects who have experienced cold or flu-like symptoms or a respiratory infection or exacerbation of COPD within 4 weeks of the study start.
Subjects who have received an investigational drug within 30 days or within 5 drug half-lives of the investigational drug (whichever is longer).
Subjects with a history (or suspected) history of alcohol misuse or any other recreational substance abuse.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main aim of this study is to investigate the effect of withdrawal of Seretide on airway inflammation and airflow limitation in chronic obstructive pulmonary disease patients using non-invasive methods (exhaled nitric oxide, exhaled breath condensate and induced sputum) and lung function tests.;Secondary Objective: A secondary aim of this study is to identify characteristics of COPD patients who may respond differently to seretide withdrawal, using the methods described.;Primary end point(s): Induced sputum inflammatory cell counts