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

Study Overview
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Brief Summary
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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.

Official Title
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A 6-week Randomized, Double-blind, Placebo-controlled, Crossover Study to Assess the Effect of Fluticasone 250μg/Salmeterol 50μg Combination (FSC 250/50) on Exertional Dyspnea in Patients With Symptomatic Mild COPD

Conditions
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COPD

Intervention / Treatment
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* Drug: fluticasone/salmeterol combination
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 41 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FSC 250/50<br>fluticasone 250μg/salmeterol 50μg combination | Drug: fluticasone/salmeterol combination<br>* Diskus inhaler, fluticasone 250μg/salmeterol 50μg, twice daily, 6-week duration<br>* Other names: Advair 250/50;|
| Placebo Comparator: Placebo<br>matched placebo inhaler | Drug: placebo<br>* Placebo Diskus inhaler, twice daily, 6-week duration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea intensity (Borg rating at a standardized time during exercise) |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild COPD, dyspnea, exercise, combination therapy