Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-03-01 @ 5:38 PM
Study NCT ID:
NCT02100267
Status:
COMPLETED
Last Update Posted:
2014-11-17
First Post:
2014-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Efficacy and Safety of Methacholine Chloride Challenge Test in Diagnosis of Adult Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016210', 'term': 'Methacholine Chloride'}], 'ancestors': [{'id': 'D008688', 'term': 'Methacholine Compounds'}, {'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'DIAGNOSTIC'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-13', 'studyFirstSubmitDate': '2014-03-24', 'studyFirstSubmitQcDate': '2014-03-26', 'lastUpdatePostDateStruct': {'date': '2014-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of methacholine challenge test (Cutoff value of PC20: 8mg/mL)', 'timeFrame': 'Visit 2 (Day 1)', 'description': 'Provocative concentration causing a 20% fall(PC20) will be captured once at visit 2.'}]}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate efficacy and safety of Methacholine Chloride challenge test in diagnosis of adult asthma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '20 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* FEV1/forced vital capacity(FVC) must be 70% or more\n* \\<10% decrease in FEV1 in response to inhalation of normal saline\n\nExclusion Criteria:\n\n* Moderate airflow limitation (FEV1 \\< 60% predicted or \\< 1.5 L)\n* Heart attack or stroke in last 3 months\n* Uncontrolled hypertension, systolic BP\\>200, or diastolic BP\\>100'}, 'identificationModule': {'nctId': 'NCT02100267', 'briefTitle': 'A Study to Evaluate Efficacy and Safety of Methacholine Chloride Challenge Test in Diagnosis of Adult Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanwa Kagaku Kenkyusho Co., Ltd.'}, 'orgStudyIdInfo': {'id': 'MC1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Asthma patients', 'interventionNames': ['Drug: Methacholine Chloride (SK-1211)']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy volunteers', 'interventionNames': ['Drug: Methacholine Chloride (SK-1211)']}], 'interventions': [{'name': 'Methacholine Chloride (SK-1211)', 'type': 'DRUG', 'description': 'Subjects received saline and 0.039-25 mg/mL of Methacholine chloride', 'armGroupLabels': ['Asthma patients', 'Healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '157-8577', 'city': 'Setagaya-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Showa University Clinical Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanwa Kagaku Kenkyusho Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}