| November 14, 2007 |
| October 16, 2009 |
| December 2007 |
| February 2010 (final data collection date for primary outcome measure) |
| Dyspnea intensity (Borg rating at a standardized time during exercise) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] |
| Dyspnea intensity (Borg rating at a standardized time during exercise) [ Time Frame: 6 weeks ] |
| Complete list of historical versions of study NCT00559312 on ClinicalTrials.gov Archive Site |
- 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 ]
|
- 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 ]
|
| |
| 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 |
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. |
| |
| |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
| COPD |
- Drug: fluticasone/salmeterol combination
- Drug: placebo
|
- Experimental: fluticasone 250μg/salmeterol 50μg combination
- Placebo Comparator: matched placebo inhaler
|
| |
| |
| Recruiting |
| 40 |
| February 2010 |
| February 2010 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 41 Years and older |
| No |
| Contact: Katherine A Webb, M.Sc. |
(613) 549-6666 ext 4950 |
kw2@queensu.ca |
|
|
| Canada |
| |
| NCT00559312 |
| Dr. Denis O'Donnell, Queen's University |
| SCO110755 |
| Queen's University |
| GlaxoSmithKline |
| Principal Investigator: |
Denis E O'Donnell, MD, FRCPC |
Queen's University and Kingston General Hospital |
|
|
| Queen's University |
| October 2009 |
