A randomised parallel group trial to investigate the effect of seretide withdrawal in Chronic Obstructive Pulmonary Disease (COPD) using non-invasive biomarkers and physiological measurements

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Respiratory; Chronic obstructive pulmonary disease (COPD)

• Registration Number: ISRCTN50541811
• Lead Sponsor: Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-30
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

12 in withdrawal group and 12 in continuation group, patients aged 40 - 75 years

Added on 09/11/2007:
1. Males or females aged 40 - 75 years inclusive
2. Ex smokers or current smokers with a cigarette smoking history of pack years (1 pack-year = 20 cigarettes smoked per day for 1 year or the equivalent)
3. Subjects with Forced Expiratory Volume in one second (FEV1) 50 - 80% of predicted normal for height, age and sex at screening visit
4. Subjects with FEV1/Forced Vital Capacity (FVC) ratio less than 70% at screening visit
5. Patients taking inhaled seretide or combined fluticasone/salmeterol at a dose of 200 - 1000 µg fluticasone and 50 - 100 µg serevent per day
6. Subjects on a stable dose of all COPD treatment over the 4 weeks prior to starting the study
7. Subjects capable of providing signed written consent to participate

Exclusion Criteria

1. Subjects taking regular oral leukotriene receptor antagonists, oral cortiscosteroids, inhaled nasal corticosteroids, oral theophylline or inhaled tiotropium for 4 weeks prior to the study start
2. Subjects having one or more exacerbations of COPD in the past 12 months requiring treatment with oral corticosteroids
3. Subjects who have had a previous admission for exacerbation of COPD requiring non-invasive or endo-tracheal intubation or admission to the Intensive Care Unit (ICU)
4. History of asthma or significant atopy/rhinitis (requiring medication)
5. Subjects with uncontrolled angina, myocardial infarction within the last 12 months or congestive cardiac failure
6. Subjects with other significant pulmonary, cardiovascular, neurological, hepatic, renal, endocrine or haematological diseases
7. Female subjects who intend to become pregnant
8. Subjects who have experienced cold or flu-like symptoms or a respiratory infection within 4 weeks of the study start
9. Subjects who have received an investigational drug within 30 days or within 5 drug half-lives of the drug
10. Subjects with a history (or suspected history) of alcohol misuse or any other recreational substance abuse

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Induced sputum inflammatory cell counts

Secondary Outcome Measures

Name	Time	Method
Added on 09/11/2007:<br>1. Exhaled breath condensate pH <br>2. Exhaled breath condensate Leukotriene B4, 8-isoprostane and other metabolites <br>3. Exhaled breath condensate and serum metabolite profiling by mass spectrometry <br>4. Exhaled nitric oxide in parts per billion (at 50 mls/sec, Caw, Calvin and Diffusing Capacity) <br>5. Induced sputum messenger Ribonucleic Acid (RNA) and protein for inflammatory mediators (e.g., Interleukin-8 [IL-8], Interleukin-6 [IL-6]) <br>6. Sputum and blood gene expression (e.g., glucocorticoid receptor) <br>7. FEV1, Maximal Expiratory Flow (MEF), FVC (measured by spirometry) <br>8. Total Lung Capacity (TLC), Residual Volume (RV), Functional Residual Capacity (FRC), Inspiratory Capacity (IC), specific airways conductance (sGaw), airway flow resistance (Raw) (measured by body plethysmography) <br>9. Resonant Frequency (RF), Respiratory resistance at 5 Hz (R5), reactance at 5 Hz (X5) (measured by impulse oscillometry)