Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2026-01-30 @ 11:24 PM
Study NCT ID:
NCT06509659
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Methacholine Challenge Test (MCT) in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016535', 'term': 'Bronchial Hyperreactivity'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-12-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-17', 'studyFirstSubmitDate': '2024-04-07', 'studyFirstSubmitQcDate': '2024-07-17', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oscillometry; R5', 'timeFrame': 'baseline (carried out with FEV1 measurement)', 'description': 'Resistance at 5 Hz; kPa/L/s with FEV1 measurement'}, {'measure': 'Oscillometry; R5', 'timeFrame': '1-10 days from baseline and carried out without FEV1 measurement', 'description': 'Resistance at 5 Hz; kPa/L/s change from baseline'}, {'measure': 'Oscillometry; R20', 'timeFrame': 'baseline (carried out without FEV1 measurement)', 'description': 'Resistance at 20 Hz; kPa/l/s with FEV1 measurement'}, {'measure': 'Oscillometry; R20', 'timeFrame': '1-10 days from baseline and carried out without FEV1 measurement', 'description': 'Resistance at 20 Hz; kPa/L/s change from baseline'}, {'measure': 'Oscillometry; X5', 'timeFrame': 'baseline (carried out without FEV1 measurement)', 'description': 'Reactance at 5 Hz; kPa/l/s with FEV1 measurement'}, {'measure': 'Oscillometry; X5', 'timeFrame': '1-10 days from baseline and carried out without FEV1 measurement', 'description': 'Reactance at 5 Hz; kPa/L/s change from baseline'}, {'measure': 'Oscillometry; AX', 'timeFrame': 'baseline (carried out without FEV1 measurement)', 'description': 'Area of reactance; kPa/L with FEV1 measurement'}, {'measure': 'Oscillometry; AX', 'timeFrame': '1-10 days from baseline and carried out without FEV1 measurement', 'description': 'Area of reactance; kPa/L change from baseline'}, {'measure': 'Oscillometry; Fres', 'timeFrame': 'baseline (carried out without FEV1 measurement)', 'description': 'Resonant frequency; Hz with FEV1 measurement'}, {'measure': 'Oscillometry; Fres', 'timeFrame': '1-10 days from baseline and carried out without FEV1 measurement', 'description': 'Resonant frequency; Hz change from baseline'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IOS', 'oscillometry', 'spirometry', 'bronchial hyperreactivity'], 'conditions': ['Hyperreactive Airway Disease']}, 'referencesModule': {'references': [{'pmid': '28461290', 'type': 'RESULT', 'citation': 'Coates AL, Wanger J, Cockcroft DW, Culver BH; Bronchoprovocation Testing Task Force: Kai-Hakon Carlsen; Diamant Z, Gauvreau G, Hall GL, Hallstrand TS, Horvath I, de Jongh FHC, Joos G, Kaminsky DA, Laube BL, Leuppi JD, Sterk PJ. ERS technical standard on bronchial challenge testing: general considerations and performance of methacholine challenge tests. Eur Respir J. 2017 May 1;49(5):1601526. doi: 10.1183/13993003.01526-2016. Print 2017 May.'}, {'pmid': '35677830', 'type': 'RESULT', 'citation': 'Cottini M, Lombardi C, Passalacqua G, Bagnasco D, Berti A, Comberiati P, Imeri G, Landi M, Heffler E. Small Airways: The "Silent Zone" of 2021 GINA Report? Front Med (Lausanne). 2022 May 23;9:884679. doi: 10.3389/fmed.2022.884679. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'Knowledge of Methacholine Challenge Test (MCT) and impedance Oscillometry (IOS) is limited. Only three studies have included adult patients, and none of these with healthy controls. The three studies have combined IOS and spirometry in the same test, although it is not recommended to perform IOS after a test that requires deep breathing, e.g. FEV1 measurement. Deep breathing is considered to affect the impedance via reduced tone in the smooth muscle.', 'detailedDescription': 'Asthma is a common chronic disease that is characterized by a history of variable respiratory symptoms and variable expiratory airflow limitation, and usually associated with airway hyperresponsiveness.\n\nIn general, FEV1 is used to test for airway hyperresponsiveness (AHR), and a 20% decrease after methacholine challenge test (MCT) is considered a positive test.\n\nThere is increasing recognition that the small airways are involved in 40-80% of patients with asthma, and the function of these airways is overlooked (the "silent zone") when measuring FEV1, which mainly reflects the function of the central airways.\n\nSmall airway dysfunction (SAD) can be assessed by IOS where pressure applied to the airways at a range of frequencies, and components of respiratory resistance and reactance are measured. Resistance at 5 Hz (R5) and 20 Hz (R20), respectively, represent total airway resistance and proximal airway resistance. The difference between these two values can be calculated (R5-R20). High R5-R20 and low reactance at 5 Hz (X5) indicate the presence of SAD.\n\nKnowledge of MCT and IOS is limited. Only three studies have included adult patients, and none of these with healthy controls. These studies have combined IOS and spirometry in the same test, although it is not recommended to perform IOS after a test that requires deep breathing, e.g. FEV1 measurement. Deep breathing is considered to affect the impedance via reduced tone in the smooth muscle.\n\nThe investigators have the following objectives for these studies:\n\n1. To determine the IOS response to MCT in healthy adults.\n2. To investigate whether spirometry (FEV1) carried out in relation to MCT influences IOS by comparing the IOS response to MCT performed with and without spirometry in healthy adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy adults', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Forced expiratory volume in the 1. second (FEV1) \\>80%\n* FEV1/FVC-ratio \\>0,7\n* FeNO \\<25 pbb\n* Oxygen saturation (SatO2) \\>95%\n* Negative methacholine Challenge Test = drop in FEV1 less than 20%\n\nExclusion Criteria:\n\n* Any lung disease\n* Lung symptoms\n* Medicine for lung disease\n* Tobacco smoking\n* Ex-smokers with more than 5 package years\n* BMI (body mass index) \\>40 kg/m2'}, 'identificationModule': {'nctId': 'NCT06509659', 'briefTitle': 'Methacholine Challenge Test (MCT) in Healthy Adults', 'organization': {'class': 'NETWORK', 'fullName': 'Allergi- og Lungeklinikken, Elsinore'}, 'officialTitle': 'Methacholine Challenge Test (MCT) in Healthy Adults: Oscillometry Measured Alone Compared to Oscillometry and FEV1 During the Same Test', 'orgStudyIdInfo': {'id': 'Elsinore_Healthy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy controls', 'description': 'No lung disease or symptoms. Negative methacholine Challenge Test.', 'interventionNames': ['Diagnostic Test: Methacholine Challenge Test']}], 'interventions': [{'name': 'Methacholine Challenge Test', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['FEV1 measurement'], 'description': 'MCT with IOS alone versus MCT IOS and FEV1 combined', 'armGroupLabels': ['Healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3140', 'city': 'Elsinore', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Thomas J Ringbæk, MSci', 'role': 'CONTACT', 'email': 'thomasringbaek@gmail.com', 'phone': '21969087'}], 'facility': 'Thomas Ringbæk', 'geoPoint': {'lat': 56.03606, 'lon': 12.6136}}], 'centralContacts': [{'name': 'Thomas Ringbæk, MSci', 'role': 'CONTACT', 'email': 'thomasringbaek@gmail.com', 'phone': '21969087'}, {'name': 'Lars Frolund, MSci', 'role': 'CONTACT', 'email': 'lars.froelund@dadlnet.dk'}], 'overallOfficials': [{'name': 'Thomas J Ringbæk', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Allergy and Lung Clinic Elsinore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergi- og Lungeklinikken, Elsinore', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Thomas Ringbæk', 'investigatorAffiliation': 'Allergi- og Lungeklinikken, Elsinore'}}}}