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

Condition(s) targeted: COPD

Intervention: fluticasone/salmeterol combination (Drug); placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Queen's University

Official(s) and/or principal investigator(s):
Denis E O'Donnell, MD, FRCPC, Principal Investigator, Affiliation: Queen's University and Kingston General Hospital

Overall contact:
Katherine A Webb, M.Sc., Phone: (613) 549-6666, Ext: 4950, Email: kw2@queensu.ca

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: 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

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

Primary outcome: Dyspnea intensity (Borg rating at a standardized time during exercise)

Secondary outcome:

Exercise endurance time

Measurements of small airway function

Exercise measurements of ventilation, breathing pattern, operating lung volumes and respiratory mechanics

Minimum age: 41 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Katherine A Webb, M.Sc., Phone: (613) 549-6666, Ext: 4950, Email: kw2@queensu.ca

Respiratory Investigation Unit at Kingston General Hospital, Kingston, Ontario K7L 2V7, Canada; Recruiting
Denis E O'Donnell, MD, FRCPC, Principal Investigator

Starting date: December 2007
Ending date: December 2009
Last updated: October 9, 2008