Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2026-01-05 @ 5:10 AM
Study NCT ID:
NCT02989935
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-18
First Post:
2016-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RELVAR Effects on Parasternal Muscle Activity, Diaphragm, and Ventilation in Severe COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014691', 'term': 'Ventilation'}], 'ancestors': [{'id': 'D004780', 'term': 'Environment, Controlled'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Study of RELVAR drug effect on respiratory physiology variables including breathing pattern, and EMG.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2016-12-01', 'studyFirstSubmitQcDate': '2016-12-07', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Minute ventilation change', 'timeFrame': '2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.', 'description': 'Minute ventilation will be averaged and compared, before and then 2 hours after the bronchodilator inhalation.'}, {'measure': 'Parasternal EMG change', 'timeFrame': '2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.', 'description': 'Change in moving averaged, EMG continuously recorded from the parasternal intercostal muscle.'}, {'measure': 'Pressure change with phrenic stimulation', 'timeFrame': '2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.', 'description': 'Change in recorded mouth pressure during magnetic stimulation of the phrenic nerves.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['respiratory muscle', 'bronchodilator'], 'conditions': ['Copd']}, 'referencesModule': {'references': [{'pmid': '19820074', 'type': 'BACKGROUND', 'citation': 'Easton PA, Hawes HG, Doig CJ, Johnson MW, Yokoba M, Wilde ER. Parasternal muscle activity decreases in severe COPD with salmeterol-fluticasone propionate. Chest. 2010 Mar;137(3):558-65. doi: 10.1378/chest.09-0197. Epub 2009 Oct 9.'}]}, 'descriptionModule': {'briefSummary': 'This study examines the effect of the ultra long acting beta agonist/corticosteroid bronchodilator combination fluticasone furoate/vilanterol trifenatate, on respiratory muscles and ventilation in adults with severe bronchitis or emphysema (COPD).', 'detailedDescription': 'In adults with severe, minimally reversible bronchitis or emphysema (COPD), there is progressive hyperinflation of the lungs with associated flattening and inefficiency of the major respiratory muscle, the diaphragm. These changes limit physical activity and exercise, and provoke shortness of breath - dyspnea.\n\nThese debilitating symptoms are often significantly lessened with ultra long acting combination bronchodilators, even in adults where the bronchodilator does not produce any measurable improvement in either airflow or lung hyperinflation.\n\nThis symptomatic improvement in adults with severe, minimally reversible COPD may occur because of a direct benefit of the bronchodilator on respiratory muscles and ventilation.\n\nThis study examines the effect of the ultra long acting bronchodilator fluticasone furoate/vilanterol trifenatate upon the upper anterior chest wall respiratory muscles (parasternals), the diaphragm, and breathing pattern.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ambulatory, stable severe COPD (GOLD Class III-IV)\n* on long acting bronchodilator therapy\n* compliant with use of prescribed medications\n* fit for minor surgical procedure including intravenous sedation\n\nExclusion Criteria:\n\n* hypersensitivity to milk proteins\n* hypersensitive to fluticasone furoate/vilanterol formulation\n* angina or substantial cardiovascular risk\n* exacerbation of COPD within the preceding 2 months\n* significant non-respiratory system disease'}, 'identificationModule': {'nctId': 'NCT02989935', 'briefTitle': 'RELVAR Effects on Parasternal Muscle Activity, Diaphragm, and Ventilation in Severe COPD', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'RELVAR Effects on Parasternal Muscle Activity, Diaphragm, and Ventilation in Severe COPD', 'orgStudyIdInfo': {'id': 'REB16-0147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluticasone vilanterol bronchodilator', 'description': 'Inhalation of fluticasone furoate/vilanterol trifenatate, 100 mcg/25 mcg combination, bronchodilator,using standard dry powder inhaler.\n\nInterventions include ventilation, parasternal EMG, and phrenic magnetic stimulation.', 'interventionNames': ['Procedure: Ventilation', 'Procedure: Parasternal EMG', 'Procedure: Phrenic magnetic stimulation']}], 'interventions': [{'name': 'Ventilation', 'type': 'PROCEDURE', 'description': 'Measurements of ventilation with subjects seated, and breathing across a pneumotachygraph and pressure transducer to measure inspiratory airflow, during both resting and CO2 stimulated breathing.', 'armGroupLabels': ['Fluticasone vilanterol bronchodilator']}, {'name': 'Parasternal EMG', 'type': 'PROCEDURE', 'description': 'Recordings of electrical activity (EMG) from the parasternal intercostal muscle in the second intercostal space on the upper anterior chest wall adjacent to the sternum.', 'armGroupLabels': ['Fluticasone vilanterol bronchodilator']}, {'name': 'Phrenic magnetic stimulation', 'type': 'PROCEDURE', 'description': 'Bilateral maximal magnetic stimulation (Magstim) of the phrenic nerves.', 'armGroupLabels': ['Fluticasone vilanterol bronchodilator']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N4N1', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'overallOfficials': [{'name': 'Paul A Easton, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'During 2020 as final results are available.', 'ipdSharing': 'YES', 'description': 'Participant physiologic results and measurements publicly presented.', 'accessCriteria': 'By researcher contact or inquiry'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc.Prof. University of Calgary', 'investigatorFullName': 'Paul Easton', 'investigatorAffiliation': 'University of Calgary'}}}}