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The Effect of Fluticasone/Salmeterol Combination on Exertional Breathlessness in Patients With Mild COPD
This study is currently recruiting participants.
Study NCT00559312   Information provided by Queen's University
First Received: November 14, 2007   Last Updated: October 16, 2009   History of Changes

November 14, 2007
October 16, 2009
December 2007
February 2010   (final data collection date for primary outcome measure)
Dyspnea intensity (Borg rating at a standardized time during exercise) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Dyspnea intensity (Borg rating at a standardized time during exercise) [ Time Frame: 6 weeks ]
Complete list of historical versions of study NCT00559312 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Exercise endurance time [ Time Frame: 6 weeks ]
  • Measurements of small airway function [ Time Frame: 6 weeks ]
  • Exercise measurements of ventilation, breathing patter, operating lung volumes and respiratory mechanics [ Time Frame: 6 weeks ]
 
The Effect of Fluticasone/Salmeterol Combination on Exertional Breathlessness in Patients With Mild COPD
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

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.

 
 
Interventional
Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Efficacy Study
Intervention Model:  Crossover Assignment
Masking:  Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose:  Treatment
COPD
  • Drug: fluticasone/salmeterol combination
    Diskus inhaler, fluticasone 250μg/salmeterol 50μg, twice daily, 6-week duration
    Other Name: Advair 250/50
  • Drug: placebo
    Placebo Diskus inhaler, twice daily, 6-week duration
  • FSC 250/50: Experimental
    fluticasone 250μg/salmeterol 50μg combination
    Intervention: Drug: fluticasone/salmeterol combination
  • Placebo: Placebo Comparator
    matched placebo inhaler
    Intervention: Drug: placebo
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
40
February 2010
February 2010   (final data collection date for primary outcome measure)

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.
Both
41 Years and older
No
Contact: Katherine A Webb, M.Sc. (613) 549-6666 ext 4950 kw2@queensu.ca
Canada
 
NCT00559312
Dr. Denis O'Donnell, Queen's University
SCO110755
Queen's University
GlaxoSmithKline
Principal Investigator: Denis E O'Donnell, MD, FRCPC Queen's University and Kingston General Hospital
Queen's University
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP