Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
Study NCT ID:
NCT00559312
Status:
COMPLETED
Last Update Posted:
2012-12-17
First Post:
2007-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Fluticasone/Salmeterol Combination on Exertional Breathlessness in Patients With Mild COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068297', 'term': 'Fluticasone-Salmeterol Drug Combination'}], 'ancestors': [{'id': 'D000068299', 'term': 'Salmeterol Xinafoate'}, {'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000068298', 'term': 'Fluticasone'}, {'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-14', 'studyFirstSubmitDate': '2007-11-14', 'studyFirstSubmitQcDate': '2007-11-14', 'lastUpdatePostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dyspnea intensity (Borg rating at a standardized time during exercise)', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Exercise endurance time', 'timeFrame': '6 weeks'}, {'measure': 'Measurements of small airway function', 'timeFrame': '6 weeks'}, {'measure': 'Exercise measurements of ventilation, breathing pattern, operating lung volumes and respiratory mechanics', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['mild COPD', 'dyspnea', 'exercise', 'combination therapy'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '41 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable mild COPD,\n* FEV1/FVC\\<0.7 and FEV1\\>60% predicted,\n* Activity-related dyspnea (i.e., Baseline Dyspnea Index focal score \\<9, MRC dyspnea scale \\>2),\n* Cigarette smoking history ≥20 pack-years.\n\nExclusion Criteria:\n\n* Presence of a significant disease other than COPD that could contribute to dyspnea and exercise limitation,\n* Important contraindications to clinical exercise testing,\n* Use of daytime oxygen,\n* History of Asthma.'}, 'identificationModule': {'nctId': 'NCT00559312', 'briefTitle': 'The Effect of Fluticasone/Salmeterol Combination on Exertional Breathlessness in Patients With Mild COPD', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'SCO110755'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FSC 250/50', 'description': 'fluticasone 250μg/salmeterol 50μg combination', 'interventionNames': ['Drug: fluticasone/salmeterol combination']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'matched placebo inhaler', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'fluticasone/salmeterol combination', 'type': 'DRUG', 'otherNames': ['Advair 250/50'], 'description': 'Diskus inhaler, fluticasone 250μg/salmeterol 50μg, twice daily, 6-week duration', 'armGroupLabels': ['FSC 250/50']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo Diskus inhaler, twice daily, 6-week duration', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K7L 2V7', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Respiratory Investigation Unit at Kingston General Hospital', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}], 'overallOfficials': [{'name': "Denis E O'Donnell, MD, FRCPC", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen's University and Kingston General Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University", 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': "Dr. Denis O'Donnell", 'investigatorAffiliation': "Queen's University"}}}}