Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-01 @ 8:18 PM
Study NCT ID:
NCT01807832
Status:
UNKNOWN
Last Update Posted:
2013-03-08
First Post:
2013-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Capsaicin Challenge for Diagnosis, Monitoring and Follow-up of Chronic Cough.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096822', 'term': 'Chronic Cough'}], 'ancestors': [{'id': 'D003371', 'term': 'Cough'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-07', 'studyFirstSubmitDate': '2013-03-07', 'studyFirstSubmitQcDate': '2013-03-07', 'lastUpdatePostDateStruct': {'date': '2013-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cough reflex hypersensitivity', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic cough', 'cough reflex hypersensitivity', 'capsaicin'], 'conditions': ['Chronic Cough']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the capsaicin challenge can improve the diagnosis, treatment, monitoring and follow-up in patients with chronic cough.', 'detailedDescription': 'Capsaicin is administrated in incremental concentrations with two inhalations of normal saline solution. Patients are instructed to exhale to functional residual capacity and than to inhale through the mouthpiece for 1 second (single breath inhalation). The number of coughs in the first 10 seconds after each inhalation is counted. C2; the concentration of which the patient responded by 2 coughs, C5;the concentration of which the patient responded by 5 coughs. The challenge ends at C5.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with persisting cough for more than 3 months, without known respiratory or lung diseases\n\nExclusion Criteria:\n\n* Diagnosis of respiratory or lung diseases of any kind'}, 'identificationModule': {'nctId': 'NCT01807832', 'briefTitle': 'The Use of Capsaicin Challenge for Diagnosis, Monitoring and Follow-up of Chronic Cough.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'The Use of Capsaicin Challenge for Diagnosis, Monitoring and Follow-up of Chronic Cough.', 'orgStudyIdInfo': {'id': 'TASMC-13-LF-0695-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'chronic cough', 'description': 'Capsaicine challenge in chronic cough patients', 'interventionNames': ['Other: capsaicin challenge']}], 'interventions': [{'name': 'capsaicin challenge', 'type': 'OTHER', 'armGroupLabels': ['chronic cough']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}