Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2026-01-01 @ 10:22 PM
Study NCT ID:
NCT05734261
Status:
RECRUITING
Last Update Posted:
2023-09-13
First Post:
2023-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Forced Oscillations Technique During a Metacholine Test in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'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', 'interventionModelDescription': 'Each subject is his or her own control'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-12', 'studyFirstSubmitDate': '2023-02-02', 'studyFirstSubmitQcDate': '2023-02-15', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in lung impedance measurement', 'timeFrame': 'During the procedure', 'description': 'Percentage change in lung impedance measurement obtained by the forced oscillation technique in relation to the dose of methacholine required to obtain bronchial hyperresponsiveness'}], 'secondaryOutcomes': [{'measure': 'Average number of trials required for measurement of FEV1 with the spirometry technique', 'timeFrame': 'During the procedure', 'description': 'Average number of trials required for technically satisfactory iterative measurement of FEV1'}, {'measure': 'Average number of trials required for impedance measurement by forced oscillation', 'timeFrame': 'During the procedure', 'description': 'Average number of trials required for technically satisfactory iterative measurement of impedance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Infant', 'Asthma', 'Diagnosis', 'Methacholin', 'Forced oscillation'], 'conditions': ['Asthma in Children']}, 'descriptionModule': {'briefSummary': 'Asthma is the most common chronic lung disease in children. It affects more than 1 in 10 children in France. The methacholine bronchial challenge test (MBT) is indicated to assess the probability of asthma suggested by clinical symptoms by measuring the forced expiratory volume in one second (FEV1), after inhalation of a cumulative dose of methacholine. In children, the measurement of FEV1 requires a high level of cooperation from the child, which can be the source of false negatives or no result if this is not obtained. The objective of this study is to evaluate if the measurement of the respiratory function by the forced oscillations technique, allows to predict the variation of the FEV1 obtained'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 6 and 16 years\n* FEV1 \\> 60%\n* Child referred to the pulmonary function test laboratory for a non-specific bronchial hyperactivity test with methacholine\n* Child under treatment with inhaled corticosteroids stopped for at least 3 weeks\n* Oral consent from the child and at least one of the legal representatives\n* Child affiliated or benefiting from a social security plan\n\nExclusion Criteria:\n\n* Use of a short-acting beta-adrenergic bronchodilator within the last 6 hours or anticholinergic bronchodilator within the last 12 hours\n* Use of a long-acting beta-adrenergic bronchodilator (licensed for use in children) in the past 36 hours\n* Upper or lower respiratory tract infections within 3 weeks prior to inclusion\n* Epilepsy under treatment\n* Subject's participation in another interventional study that may alter respiratory function\n* Patient unable to give consent, vulnerable"}, 'identificationModule': {'nctId': 'NCT05734261', 'acronym': 'TPM AOS', 'briefTitle': 'Forced Oscillations Technique During a Metacholine Test in Children', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Interest of Forced Oscillations During a Methacholine Test in Children', 'orgStudyIdInfo': {'id': 'RECHMPL22_0504'}, 'secondaryIdInfos': [{'id': '2022-A02437-36', 'type': 'OTHER', 'domain': 'ANSM'}, {'id': 'RECHMPL22_0504', 'type': 'OTHER', 'domain': 'CHU de Montpellier'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single Arm', 'interventionNames': ['Procedure: Airway Oscillation System']}], 'interventions': [{'name': 'Airway Oscillation System', 'type': 'PROCEDURE', 'otherNames': ['Tremoflo'], 'description': 'After each methacholine dose administred, respiratory function will be measured by forced oscillation', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne Requirand', 'role': 'CONTACT', 'email': 'a-requirand@chu-montpellier.fr'}], 'facility': 'CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'Stefan MATECKI, MD', 'role': 'CONTACT', 'email': 'Stephan.matecki@umontpellier.fr', 'phone': '+33 4 67 33 59 12'}, {'name': 'Anne REQUIRAND', 'role': 'CONTACT', 'email': 'a-requirand@chu-montpellier.fr'}], 'overallOfficials': [{'name': 'Stefan MATECKI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montpellier Univerty Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}