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

Tracking Information

First Received Date ^ICMJE

November 14, 2007

Last Updated Date

October 16, 2009

Start Date ^ICMJE

December 2007

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Dyspnea intensity (Borg rating at a standardized time during exercise) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00559312 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Efficacy Study
Intervention Model:  Crossover Assignment
Masking:  Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose:  Treatment

Condition ^ICMJE

COPD

Intervention ^ICMJE

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

Study Arms / Comparison Groups

FSC 250/50: Experimental
fluticasone 250μg/salmeterol 50μg combination

Intervention: Drug: fluticasone/salmeterol combination
Placebo: Placebo Comparator
matched placebo inhaler

Intervention: Drug: placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2010

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

41 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Katherine A Webb, M.Sc.

(613) 549-6666 ext 4950

kw2@queensu.ca

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00559312

Responsible Party

Dr. Denis O'Donnell, Queen's University

Study ID Numbers ^ICMJE

SCO110755

Study Sponsor ^ICMJE

Queen's University

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

Principal Investigator:

Denis E O'Donnell, MD, FRCPC

Queen's University and Kingston General Hospital

Information Provided By

Queen's University

Verification Date

October 2009

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