Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-02-20 @ 10:58 PM
Study NCT ID:
NCT01851993
Status:
COMPLETED
Last Update Posted:
2015-08-26
First Post:
2013-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inhaled Ondansetron & Dyspnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017294', 'term': 'Ondansetron'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-24', 'studyFirstSubmitDate': '2013-05-07', 'studyFirstSubmitQcDate': '2013-05-10', 'lastUpdatePostDateStruct': {'date': '2015-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensory Intensity (Borg 0-10 scale) ratings of dyspnea at isotime', 'timeFrame': 'Participants will be followed until all study visits are complete, an expected average of 3 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ondansetron', 'Exercise'], 'conditions': ['Dyspnea']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mcgill.ca/cerpl', 'label': 'Clinical Exercise \\& Respiratory Physiology Laboratory (CERPL) of McGill University'}]}, 'descriptionModule': {'briefSummary': '"Dyspnea" refers to the awareness of breathing discomfort that is typically experienced during exercise in health and disease. In various participant populations, dyspnea is a predictor of disability and death; and contributes to exercise intolerance and an adverse health-related quality-of-life. It follows that alleviating dyspnea and improving exercise tolerance are among the principal goals of disease management. Nevertheless, the effective management of dyspnea and activity-limitation remains an elusive goal for many healthcare providers and current strategies aimed at reversing the underlying chronic disease are only partially successful in this regard. Thus, research aimed at identifying dyspnea-specific medications to complement existing therapies for the management of exertional symptoms is timely and clinically relevant. The purpose of this study is to test the hypothesis that single-dose inhalation of nebulized ondansetron (a serotonin 5-HT3 receptor antagonist) will improve the perception of dyspnea during strenuous exercise in health, young men. To this end, the investigators will compare the effects of inhaled 0.9% saline placebo and inhaled ondansetron (8 mg) on detailed assessments of neural respiratory drive (diaphragm EMG), ventilation, breathing pattern, dynamic operating lung volumes, contractile respiratory muscle function, cardio-metabolic function and dyspnea (sensory intensity and affective responses) during symptom-limited, high-intensity, constant-work-rate cycle exercise testing in healthy, men aged 20-40 years.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* Aged 20-40 years\n* FEV1 ≥80% predicted\n* FEV1/FVC \\>70%\n\nExclusion Criteria:\n\n* Current or ex-smoker\n* Body Mass Index \\<18.5 or \\>30 kg/m2\n* History of cardiovascular, vascular, respiratory, renal, liver, musculoskeletal, endocrine, neuromuscular and/or metabolic disease/dysfunction.\n* Taking doctor prescribed medications\n* Allergy to latex\n* Allergy to lidocaine or its "caine" derivatives'}, 'identificationModule': {'nctId': 'NCT01851993', 'briefTitle': 'Inhaled Ondansetron & Dyspnea', 'organization': {'class': 'OTHER', 'fullName': 'McGill University'}, 'officialTitle': 'Effects of Inhaled Ondansetron on Perceived Respiratory Discomfort (Dyspnea) During Exercise in the Presence of External Thoracic Restriction', 'orgStudyIdInfo': {'id': 'A02-M16-13B Ondansetron'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inhaled Ondansetron (8 mg)', 'description': 'Single-dose inhalation of nebulized ondansetron (8 mg)', 'interventionNames': ['Drug: Ondansetron']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Inhaled 0.9% saline placebo', 'description': 'Single-dose inhalation of 0.9% saline placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ondansetron', 'type': 'DRUG', 'armGroupLabels': ['Inhaled Ondansetron (8 mg)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '0.9% saline', 'armGroupLabels': ['Inhaled 0.9% saline placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2W1S4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Clinical Exercise & Respiratory Physiology Laboratory (CERPL) of McGill University', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Dennis Jensen, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dennis Jensen, Ph.D.', 'investigatorAffiliation': 'McGill University'}}}}