Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 11:30 PM
Study NCT ID:
NCT03423693
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2018-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Small Airway Obstruction in Asthma, COPD, ACOS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D000080445', 'term': 'Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome'}], '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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Sputum cell pellets, sputum supernatants, and sputum cytospins'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-16', 'studyFirstSubmitDate': '2018-01-30', 'studyFirstSubmitQcDate': '2018-02-05', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lipoxin A4, ,', 'timeFrame': '1 day (single time point)', 'description': 'Lipoxin A4 is measured in sputum supernatants by ELISA'}], 'secondaryOutcomes': [{'measure': 'IL-33', 'timeFrame': '1 day (single time point)', 'description': 'IL-33 is measured in sputum supernatants by ELISA'}, {'measure': 'Thymic stromal lymphopoietin (TSLP)', 'timeFrame': '1 day (single time point)', 'description': 'TSLP is measured in sputum supernatants by ELISA'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Small airway obstruction', 'Asthma', 'COPD', 'ACOS'], 'conditions': ['Asthma', 'COPD', 'Asthma-COPD Overlap Syndrome']}, 'descriptionModule': {'briefSummary': 'This study was designed as retrospective chart review to test our hypothesis whether there are the differences in inflammatory and anti-inflammatory mediators between asthmatic and ACOS patients with small airway obstruction, and COPD', 'detailedDescription': 'The data including spirometry, lung volume, impulse oscillometry, sputum data, demographic characters within 6 months are collected for later analysis. Sputum supernatants and cytospins are used to determine inflammatory and anti-inflammatory responses in those patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants recruited from Asthma Clinics and OPD in Siriraj Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physician-diagnosed asthma, ACO, and COPD\n* Their spirometric, IOS, lung volume, demographic data and sputum samples are available\n\nExclusion Criteria:\n\n* Concomitant diseases requiring immunosuppressive therapy\n* Being on treatments with NSAIDs, macrolides, statins'}, 'identificationModule': {'nctId': 'NCT03423693', 'briefTitle': 'Small Airway Obstruction in Asthma, COPD, ACOS', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Comparative Study on Sputum Anti-inflammatory Mediators in Patients With Asthma or Asthma and COPD Overlap (ACOS) Syndrome, and COPD', 'orgStudyIdInfo': {'id': 'Si527/2015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Asthma with SAO+', 'description': 'Asthmatic patients with RV/TLC \\> or = 40', 'interventionNames': ['Other: No any intervention']}, {'label': 'Asthma with SAO-', 'description': 'Asthmatic patients with RV/TLC \\< 40', 'interventionNames': ['Other: No any intervention']}, {'label': 'ACO', 'description': 'Asthmatic patients with smoking \\> or = 10 pack years who have persistent airway obstruction (post-BD FEV1/FVC \\< 0.7) or COPD patients who have bronchodilator (BD) reversibility (absolute increase in FEV1 \\> or = 200 ml and FEV1% \\> or =12% after BD)', 'interventionNames': ['Other: No any intervention']}, {'label': 'COPD', 'description': 'Patients with history of smoking \\> or = 10 pack year with post-BD FEV1/FVC \\< 0.7 and negative BD reversibility (absolute increase in FEV1 \\< 200 ml and FEV1% \\<12% after BD)', 'interventionNames': ['Other: No any intervention']}], 'interventions': [{'name': 'No any intervention', 'type': 'OTHER', 'description': 'No any intervention is applied to any groups in this study', 'armGroupLabels': ['ACO', 'Asthma with SAO+', 'Asthma with SAO-', 'COPD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok Noi', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Siriraj Hospital', 'geoPoint': {'lat': 13.76266, 'lon': 100.47798}}], 'overallOfficials': [{'name': 'Kittipong Maneechotesuwan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Siriraj Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kittipong Maneechotesuwan', 'investigatorAffiliation': 'Mahidol University'}}}}