Official Title: “A 6-Week Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Assess the Effect of Fluticasone 500μg/Salmeterol 50μg Combination (FSC 500/50) on Exertional Dyspnea in Patients With Symptomatic Mild COPD”

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 500μg/salmeterol 50μg (FSC500/50)] 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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: December 2009

Intervention(s) in this Clinical Trial

• Drug: fluticasone/salmeterol combination
  • Diskus inhaler, fluticasone 500μg/salmeterol 50μg, twice daily, 6-week duration
• Drug: placebo
  • Placebo Diskus inhaler, twice daily, 6-week duration

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • fluticasone 500μg/salmeterol 50μg combination
• Placebo Comparator: 2
  • matched placebo inhaler

Primary Measures

• Dyspnea intensity (Borg rating at a standardized time during exercise)
  • Time Frame: 6 weeks
    Safety Issue?: No

Secondary Measures

• Exercise endurance time
  • Time Frame: 6 weeks
    Safety Issue?: No
• Measurements of small airway function
  • Time Frame: 6 weeks
    Safety Issue?: No
• Exercise measurements of ventilation, breathing pattern, operating lung volumes and respiratory mechanics
  • Time Frame: 6 weeks
    Safety Issue?: No

Inclusion Criteria:

• Stable mild COPD,
• FEV1/FVC<0.7 and FEV1>60% predicted,
• Baseline Dyspnea Index focal score <9 and 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 41 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Queen's University

Overall Clinical Trial Officials and Contacts

Denis E O'Donnell, MD, FRCPC Principal Investigator Queen's University and Kingston General Hospital  

Overall Contact: Katherine A Webb, M.Sc. (613) 549-6666 kw2@queensu.ca

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00559312

Study ID Number: SCO110755

ClinicalTrials.gov Identifier: NCT00559312

Health Authority: Canada: Ethics Review Committee