Skip to main content
OpenTrials
Completed

NCT Number: NCT00559312

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COPD Behavior Chronic Disease Disease Attributes Dyspnea Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

41 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Respiratory Investigation Unit at Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fluticasone/salmeterol combination

Drug

Diskus inhaler, fluticasone 250μg/salmeterol 50μg, twice daily, 6-week duration

Other names: Advair 250/50

Placebo

Drug

Placebo Diskus inhaler, twice daily, 6-week duration

Primary outcomes

  1. Dyspnea intensity (Borg rating at a standardized time during exercise)

    Time frame: 6 weeks

Secondary outcomes

  1. Exercise endurance time

    Time frame: 6 weeks

  2. Measurements of small airway function

    Time frame: 6 weeks

  3. Exercise measurements of ventilation, breathing pattern, operating lung volumes and respiratory mechanics

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Nov 16, 2007
Registry last updated
Dec 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.