The Effect of Fluticasone/Salmeterol Combination on Exertional Breathlessness in Patients With Mild COPD

Not Applicable

Completed

• Conditions: COPD
• Interventions: Drug: fluticasone/salmeterol combination; Drug: placebo

• Registration Number: NCT00559312
• Lead Sponsor: Queen's University

Brief Summary

Even patients with milder COPD can have significant physiological abnormalities which become more pronounced during exercise, leading to intolerable breathing discomfort (dyspnea). While there is a compelling physiological rationale for the efficacy of inhaled corticosteroid/long-acting bronchodilator combination therapy \[i.e., fluticasone 250μg/salmeterol 50μg (FSC250/50)\] in moderate to severe COPD, little information is available on the potential impact of this therapy in milder symptomatic disease. This study will be the first to explore mechanisms of dyspnea and activity limitation in milder COPD and will determine if there is a sound physiological rationale for the use of FSC as therapy for this subpopulation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-14
• Study First Submitted QC: 2007-11-14
• Study First Posted: 2007-11-16
• Study Start: 2007-12
• Primary Completion: 2010-03
• Study Completion: 2010-04
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-14
• Last Update Posted: 2012-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Stable mild COPD,
• FEV1/FVC<0.7 and FEV1>60% predicted,
• Activity-related dyspnea (i.e., Baseline Dyspnea Index focal score <9, MRC dyspnea scale >2),
• Cigarette smoking history ≥20 pack-years.

Exclusion Criteria

• Presence of a significant disease other than COPD that could contribute to dyspnea and exercise limitation,
• Important contraindications to clinical exercise testing,
• Use of daytime oxygen,
• History of Asthma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
FSC 250/50	fluticasone/salmeterol combination	fluticasone 250μg/salmeterol 50μg combination
Placebo	placebo	matched placebo inhaler

Primary Outcome Measures

Name	Time	Method
Dyspnea intensity (Borg rating at a standardized time during exercise)	6 weeks

Secondary Outcome Measures

Name	Time	Method
Exercise endurance time	6 weeks
Measurements of small airway function	6 weeks
Exercise measurements of ventilation, breathing pattern, operating lung volumes and respiratory mechanics	6 weeks

Trial Locations

Locations (1)

Respiratory Investigation Unit at Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada