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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00559312

Enrollment

Registered

2007-11-16

Start date

2007-12-31

Completion date

2010-04-30

Last updated

2012-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

mild COPD, dyspnea, exercise, combination therapy

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.

Interventions

DRUGfluticasone/salmeterol combination

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

DRUGplacebo

Placebo Diskus inhaler, twice daily, 6-week duration

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

41 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026