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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Dr. Denis O'Donnell, Queen's University
ClinicalTrials.gov Identifier:
NCT00559312
First received: November 14, 2007
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  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
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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   41 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Denis O'Donnell, Principal Investigator, Queen's University
ClinicalTrials.gov 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
dyspnea
exercise
combination therapy

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Salmeterol
Albuterol
Fluticasone
Fluticasone, salmeterol drug combination
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 23, 2013