Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-21 @ 3:11 PM
Study NCT ID:
NCT02715167
Status:
UNKNOWN
Last Update Posted:
2016-03-22
First Post:
2016-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Factors in Response to Inhaled Corticoids in Chronic Cough
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-16', 'studyFirstSubmitDate': '2016-03-04', 'studyFirstSubmitQcDate': '2016-03-16', 'lastUpdatePostDateStruct': {'date': '2016-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leicester cough questionnaire', 'timeFrame': '5 minutes'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The hypothesis is that a high fractional exhaled nitric oxide can predict the response to inhaled corticoids in chronic cough.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic cough\n\nExclusion Criteria:\n\n* active smoker\n* treated by corticoids during the previous month\n* use of angiotensin-converting-enzyme inhibitor'}, 'identificationModule': {'nctId': 'NCT02715167', 'acronym': 'FeNOTX', 'briefTitle': 'Predictive Factors in Response to Inhaled Corticoids in Chronic Cough', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'orgStudyIdInfo': {'id': 'FeNOTX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group Budesonide', 'description': 'Inhaled corticoids', 'interventionNames': ['Drug: Budesonide novolizer']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group Placebo', 'description': 'Placebo by inhalation', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Budesonide novolizer', 'type': 'DRUG', 'armGroupLabels': ['Group Budesonide']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Group Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Rougui Ihsan, MD', 'role': 'CONTACT', 'email': 'ihsan.rougui@hotmail.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}