Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2025-12-27 @ 4:15 PM
Study NCT ID:
NCT04616261
Status:
UNKNOWN
Last Update Posted:
2020-11-04
First Post:
2020-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Beta2-adrenergic System and Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068759', 'term': 'Formoterol Fumarate'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-11-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2022-11-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-03', 'studyFirstSubmitDate': '2020-10-29', 'studyFirstSubmitQcDate': '2020-11-03', 'lastUpdatePostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sprint performance', 'timeFrame': '½ hour after administration of formoterol or placebo', 'description': 'Change in power output during maximal cycling in response to formoterol'}], 'secondaryOutcomes': [{'measure': 'Cycling endurance performance', 'timeFrame': '½ hour after administration of formoterol or placebo', 'description': 'Change in 4-min time trial performance in response to formoterol'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This project aims to examine the trainability of the beta2-adrenergic system with respect to the individual performance response'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 45 years of age\n* Trained individuals with a maximal oxygen uptake above 55 ml/min/kg\n* Body mass index lower than 26\n\nExclusion Criteria:\n\n* Allergy towards study drug\n* Unacceptable side effects to the study drug\n* Chronic disease deemed by the MD to interfere with the study\n* Smoking\n* Use of prescription medicine'}, 'identificationModule': {'nctId': 'NCT04616261', 'briefTitle': 'Beta2-adrenergic System and Training', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Trainability of the beta2-adrenergic System With Respect to Performance', 'orgStudyIdInfo': {'id': 'FOREX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SET-HIGH', 'description': 'High volume speed endurance training', 'interventionNames': ['Behavioral: Training', 'Drug: Formoterol', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SET-LOW', 'description': 'Low volume speed endurance training', 'interventionNames': ['Behavioral: Training', 'Drug: Formoterol', 'Drug: Placebo']}], 'interventions': [{'name': 'Training', 'type': 'BEHAVIORAL', 'description': '6 weeks of training', 'armGroupLabels': ['SET-HIGH', 'SET-LOW']}, {'name': 'Formoterol', 'type': 'DRUG', 'description': 'inhalation of 54 microg formoterol', 'armGroupLabels': ['SET-HIGH', 'SET-LOW']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'inhalation of placebo', 'armGroupLabels': ['SET-HIGH', 'SET-LOW']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Morten Hostrup, PhD', 'investigatorAffiliation': 'University of Copenhagen'}}}}