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

This study has been completed.
Information provided by (Responsible Party):
Dr. Denis O'Donnell, Queen's University Identifier:
First received: November 14, 2007
Last updated: December 14, 2012
Last verified: December 2012

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.

Condition Intervention
Drug: fluticasone/salmeterol combination
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Dyspnea intensity (Borg rating at a standardized time during exercise) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exercise endurance time [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Measurements of small airway function [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Exercise measurements of ventilation, breathing pattern, operating lung volumes and respiratory mechanics [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: December 2007
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FSC 250/50
fluticasone 250μg/salmeterol 50μg combination
Drug: fluticasone/salmeterol combination
Diskus inhaler, fluticasone 250μg/salmeterol 50μg, twice daily, 6-week duration
Other Name: Advair 250/50
Placebo Comparator: Placebo
matched placebo inhaler
Drug: placebo
Placebo Diskus inhaler, twice daily, 6-week duration


Ages Eligible for Study:   41 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00559312

Canada, Ontario
Respiratory Investigation Unit at Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Queen's University
Principal Investigator: Denis E O'Donnell, MD, FRCPC Queen's University and Kingston General Hospital
  More Information

No publications provided

Responsible Party: Dr. Denis O'Donnell, Principal Investigator, Queen's University Identifier: NCT00559312     History of Changes
Other Study ID Numbers: SCO110755
Study First Received: November 14, 2007
Last Updated: December 14, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Queen's University:
mild COPD
combination therapy

Additional relevant MeSH terms:
Fluticasone, salmeterol drug combination
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents processed this record on November 24, 2014