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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FSC 250/50 | Experimental | fluticasone 250μg/salmeterol 50μg combination |
|
| Placebo | Placebo Comparator | matched placebo inhaler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone/salmeterol combination | Drug | Diskus inhaler, fluticasone 250μg/salmeterol 50μg, twice daily, 6-week duration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dyspnea intensity (Borg rating at a standardized time during exercise) | 6 weeks |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denis E O'Donnell, MD, FRCPC | Queen's University and Kingston General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Respiratory Investigation Unit at Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004417 | Dyspnea |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
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| placebo | Drug | Placebo Diskus inhaler, twice daily, 6-week duration |
|
| 6 weeks |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |
| D000438 |
| Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000068298 | Fluticasone |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |