Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2026-01-02 @ 12:29 AM
Study NCT ID:
NCT01381666
Status:
TERMINATED
Last Update Posted:
2015-10-29
First Post:
2011-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Diagnostic Utility of INS316 in Patients With Interstitial Lung Diseases (01-701)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Israel']}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001239', 'term': 'Inhalation'}, {'id': 'D012462', 'term': 'Saline Solution, Hypertonic'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D015656', 'term': 'Respiratory Mechanics'}, {'id': 'D012119', 'term': 'Respiration'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D006982', 'term': 'Hypertonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'dispFirstSubmitDate': '2011-06-24', 'completionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-07', 'studyFirstSubmitDate': '2011-06-23', 'dispFirstSubmitQcDate': '2011-06-24', 'studyFirstSubmitQcDate': '2011-06-24', 'dispFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diagnosis of sarcoidosis using sputum induction (sputum weight)', 'timeFrame': '60 minutes'}], 'secondaryOutcomes': [{'measure': 'adverse events', 'timeFrame': '60 minutes'}]}, 'conditionsModule': {'conditions': ['Interstitial Lung Disease']}, 'descriptionModule': {'briefSummary': 'The objective of the present work is to explore and compare the diagnostic quality of sputum specimens obtained by BAL, induction with hypertonic saline (3%), and induction with INS316 in patients diagnosed with interstitial lung diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between 18 years or older\n* undergone diagnostic bronchoalveolar lavage within the previous 21 days\n* diagnosed with sarcoidosis or other ILD\n\nExclusion Criteria:\n\n* having resting hypoxemia\n* receiving corticosteroid treatment'}, 'identificationModule': {'nctId': 'NCT01381666', 'briefTitle': 'Evaluation of the Diagnostic Utility of INS316 in Patients With Interstitial Lung Diseases (01-701)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'orgStudyIdInfo': {'id': '01-701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INS316', 'description': 'inhalation via nebulizer given for 2 doses for 60 minutes each', 'interventionNames': ['Drug: INS316 solution for inhalation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'hypertonic saline 3% sodium chloride solution', 'description': 'inhalation via nebulizer given for 2 doses for 60 minutes each', 'interventionNames': ['Drug: hypertonic saline 3% sodium chloride solution']}], 'interventions': [{'name': 'INS316 solution for inhalation', 'type': 'DRUG', 'description': 'inhalation via nebulizer given for 2 doses for 60 minutes each', 'armGroupLabels': ['INS316']}, {'name': 'hypertonic saline 3% sodium chloride solution', 'type': 'DRUG', 'description': 'inhalation via nebulizer given for 2 doses for 60 minutes each', 'armGroupLabels': ['hypertonic saline 3% sodium chloride solution']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}