MedDataX Logo

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

NCT ID: NCT00559312

Last Updated: 2012-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

mild COPD dyspnea exercise combination therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FSC 250/50

fluticasone 250μg/salmeterol 50μg combination

Group Type EXPERIMENTAL

fluticasone/salmeterol combination

Intervention Type DRUG

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

Placebo

matched placebo inhaler

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo Diskus inhaler, twice daily, 6-week duration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fluticasone/salmeterol combination

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

Intervention Type DRUG

placebo

Placebo Diskus inhaler, twice daily, 6-week duration

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Advair 250/50

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

41 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Queen's University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Denis O'Donnell

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Denis E O'Donnell, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Queen's University and Kingston General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Respiratory Investigation Unit at Kingston General Hospital

Kingston, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SCO110755

Identifier Type: -

Identifier Source: org_study_id