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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00559312
First Posted: November 16, 2007
Last Update Posted: December 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Dr. Denis O'Donnell, Queen's University
  Purpose
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
COPD Drug: fluticasone/salmeterol combination Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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 Dr. Denis O'Donnell, Queen's University:

Primary Outcome Measures:
  • Dyspnea intensity (Borg rating at a standardized time during exercise) [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Exercise endurance time [ Time Frame: 6 weeks ]
  • Measurements of small airway function [ Time Frame: 6 weeks ]
  • Exercise measurements of ventilation, breathing pattern, operating lung volumes and respiratory mechanics [ Time Frame: 6 weeks ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   41 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559312


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

Responsible Party: Dr. Denis O'Donnell, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT00559312     History of Changes
Other Study ID Numbers: SCO110755
First Submitted: November 14, 2007
First Posted: November 16, 2007
Last Update Posted: December 17, 2012
Last Verified: December 2012

Keywords provided by Dr. Denis O'Donnell, Queen's University:
mild COPD
dyspnea
exercise
combination therapy

Additional relevant MeSH terms:
Fluticasone
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics