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

COPD Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559312
• Other study ID #: SCO110755
• Status: Completed
• Phase: N/A
• First received: November 14, 2007
• Last updated: December 14, 2012
• Start date: December 2007
• Est. completion date: April 2010

Study information

• Verified date: December 2012
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 41 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• COPD

Intervention

Drug:
• fluticasone/salmeterol combination
Diskus inhaler, fluticasone 250µg/salmeterol 50µg, twice daily, 6-week duration
• placebo
Placebo Diskus inhaler, twice daily, 6-week duration

Locations

Country	Name	City	State
Canada	Respiratory Investigation Unit at Kingston General Hospital	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	GlaxoSmithKline

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dyspnea intensity (Borg rating at a standardized time during exercise)		6 weeks	No
Secondary	Exercise endurance time		6 weeks	No
Secondary	Measurements of small airway function		6 weeks	No
Secondary	Exercise measurements of ventilation, breathing pattern, operating lung volumes and respiratory mechanics		6 weeks	No