Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
Study NCT ID:
NCT06066606
Status:
RECRUITING
Last Update Posted:
2025-04-10
First Post:
2023-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
U-LABA/ICS Effects on Exercise Performance, Vilanterol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C550468', 'term': 'vilanterol'}, {'id': 'C523187', 'term': 'fluticasone furoate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2023-09-20', 'studyFirstSubmitQcDate': '2023-09-27', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Forced Expiratory Volume in 1 second (FEV1)', 'timeFrame': 'Through study completion, an average of 3 weeks', 'description': 'FEV1 measured by spirometry'}, {'measure': 'Quadriceps strength', 'timeFrame': 'Through study completion, an average of 3 weeks', 'description': 'Maximal torque (Nm) achieved during isometric contraction'}, {'measure': 'Respiratory muscle function', 'timeFrame': 'Through study completion, an average of 3 weeks', 'description': 'Mouth inspiratory and expiratory pressures against a closed system'}], 'primaryOutcomes': [{'measure': 'Power output during sprint testing', 'timeFrame': 'Through study completion, an average of 3 weeks', 'description': 'Power output measured in Watts during a sprint on a bike ergometer'}], 'secondaryOutcomes': [{'measure': 'Power output during time trial', 'timeFrame': 'Through study completion, an average of 3 weeks', 'description': 'Mean power output measured in Watts during a time trial on a bike ergometer'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Exercise Performance']}, 'descriptionModule': {'briefSummary': 'The purpose of the project is to investigate exercise performance in humans following bronchodilation induced by acute inhalation of beta2-agonist vilanterol + fluticasone furoate'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-39\n* Physically active \\> 5 h weekly\n* Maximal oxygen consumption classified as high or very high\n\nExclusion Criteria:\n\n* Diagnosed with severe asthma and been in treatment with long-acting beta2-agonist/corticosteroid\n* ECG abnormality\n* ACQ score \\> 1.5\n* Severe bronchial hyperreactivity as determined by mannitol test\n* FEV1/FVC ratio \\< 0.7 determined with spirometry\n* Chronic illness determined to be a potential risk for participant during study\n* In chronic treatment with medication that may interfere with study results\n* Pregnancy\n* Smoker\n* Blood donation during the past 3 months'}, 'identificationModule': {'nctId': 'NCT06066606', 'briefTitle': 'U-LABA/ICS Effects on Exercise Performance, Vilanterol', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Physiological Response to U-LABA/ICS With Emphasis on Exercise Performance, Vilanterol', 'orgStudyIdInfo': {'id': 'VIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vilanterol + fluticasone furoate', 'description': 'Participants are administered Vilanterol + fluticasone furoate from an inhaler device testing', 'interventionNames': ['Drug: Vilanterol and Fluticasone Furoate (low dose)', 'Drug: Vilanterol and Fluticasone Furoate (high dose)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants are administered placebo from an inhaler device testing', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vilanterol and Fluticasone Furoate (low dose)', 'type': 'DRUG', 'description': 'Participants are administered 25 µg of vilanterol + fluticasone furoate', 'armGroupLabels': ['Vilanterol + fluticasone furoate']}, {'name': 'Vilanterol and Fluticasone Furoate (high dose)', 'type': 'DRUG', 'description': 'Participants are administered 100 µg of vilanterol + fluticasone furoate', 'armGroupLabels': ['Vilanterol + fluticasone furoate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants are administered placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'DK', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Morten Hostrup, PhD', 'role': 'CONTACT'}], 'facility': 'August Krogh Building', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Morten Hostrup, PhD', 'role': 'CONTACT', 'email': 'mhostrup@nexs.ku.dk', 'phone': '+4535321595'}], 'overallOfficials': [{'name': 'Morten Hostrup, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Morten Hostrup, PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Morten Hostrup, PhD', 'investigatorAffiliation': 'University of Copenhagen'}}}}