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

December 14, 2012 updated by: Dr. Denis O'Donnell, Queen's University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Respiratory Investigation Unit at Kingston General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

37 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Advair 250/50
Placebo Comparator: Placebo
matched placebo inhaler
Drug: placebo
Placebo Diskus inhaler, twice daily, 6-week duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dyspnea intensity (Borg rating at a standardized time during exercise)
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Denis E O'Donnell, MD, FRCPC, Queen's University and Kingston General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

November 14, 2007

First Submitted That Met QC Criteria

November 14, 2007

First Posted (Estimate)

November 16, 2007

Study Record Updates

Last Update Posted (Estimate)

December 17, 2012

Last Update Submitted That Met QC Criteria

December 14, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCO110755

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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