Ignite Creation Date:
2025-12-24 @ 10:18 PM
Ignite Modification Date:
2025-12-25 @ 7:51 PM
Study NCT ID:
NCT03467035
Status:
UNKNOWN
Last Update Posted:
2018-03-15
First Post:
2018-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of NLRP3 Inflammasone and Hypoxia in the Severity of Osteoporosis in Patients With Bronchiectasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The remaining samples after the completion of this study are deposited in the Human Genome Database of Chang Gung Memorial Medical Center \\_ Linkou \\_\\_ Chang Gung Memorial Hospital for the follow-up study (including gene research) approved by the Human Ethics Committee of the Hospital'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-14', 'studyFirstSubmitDate': '2018-03-07', 'studyFirstSubmitQcDate': '2018-03-14', 'lastUpdatePostDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'six minute walk test', 'timeFrame': '6 months', 'description': 'six minute walk test distance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bronchiectasis Adult', 'Osteoporosis, Osteopenia']}, 'referencesModule': {'references': [{'pmid': '3533593', 'type': 'BACKGROUND', 'citation': 'Cole PJ. Inflammation: a two-edged sword--the model of bronchiectasis. Eur J Respir Dis Suppl. 1986;147:6-15.'}, {'pmid': '20655868', 'type': 'BACKGROUND', 'citation': 'Arnett TR. Acidosis, hypoxia and bone. Arch Biochem Biophys. 2010 Nov 1;503(1):103-9. doi: 10.1016/j.abb.2010.07.021. Epub 2010 Jul 23.'}, {'pmid': '20556743', 'type': 'BACKGROUND', 'citation': 'Utting JC, Flanagan AM, Brandao-Burch A, Orriss IR, Arnett TR. Hypoxia stimulates osteoclast formation from human peripheral blood. Cell Biochem Funct. 2010 Jul;28(5):374-80. doi: 10.1002/cbf.1660.'}, {'pmid': '26493990', 'type': 'BACKGROUND', 'citation': 'Kim RY, Pinkerton JW, Gibson PG, Cooper MA, Horvat JC, Hansbro PM. Inflammasomes in COPD and neutrophilic asthma. Thorax. 2015 Dec;70(12):1199-201. doi: 10.1136/thoraxjnl-2014-206736. Epub 2015 Oct 22. No abstract available.'}, {'pmid': '27911973', 'type': 'BACKGROUND', 'citation': 'Diehl N, Johnson MM. Prevalence of Osteopenia and Osteoporosis in Patients with Noncystic Fibrosis Bronchiectasis. South Med J. 2016 Dec;109(12):779-783. doi: 10.14423/SMJ.0000000000000565.'}, {'pmid': '27864036', 'type': 'BACKGROUND', 'citation': 'McDonnell MJ, Aliberti S, Goeminne PC, Restrepo MI, Finch S, Pesci A, Dupont LJ, Fardon TC, Wilson R, Loebinger MR, Skrbic D, Obradovic D, De Soyza A, Ward C, Laffey JG, Rutherford RM, Chalmers JD. Comorbidities and the risk of mortality in patients with bronchiectasis: an international multicentre cohort study. Lancet Respir Med. 2016 Dec;4(12):969-979. doi: 10.1016/S2213-2600(16)30320-4. Epub 2016 Nov 16.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this research grant are to determine the association of hypoxia with the severity of osteoporosis in the patients with bronchiectasis and whether the mechanism of inflammation is triggered by inflammasones, which makes it more prone to osteoporosis in patients with bronchiectasis.', 'detailedDescription': '80 patients with proven bronchiectasis, diagnosed by high-resolution computed tomography (HRCT), will be recruited from our outpatient clinic of Chang Gung Memorial Hospital with written informed consent. Inclusion criteria are: daily sputum \\> 10 ml; absence of asthma or other unstable systemic diseases; and "steady-state" bronchiectasis (\\< 10% alteration of 24 h sputum volume, FEV1, and FVC, and in the absence of deterioration in respiratory symptoms at baseline visits). Exclusion criteria include: unreliable clinic attendance; regular user of inhaled or oral corticosteroids; history of lung resection and known asthma defined according to American Thoracic Society guidelines.\n\nThe lung function and desaturation will be assessed by six-minute walking tests and the severity of disease will be evaluated by HRCT scores. Peripheral blood sample (40ml/person) is performed to analyze the bone turnover markers and the level of Hif in PBMC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '80 adult patients with proven bronchiectasis, diagnosed by high-resolution computed tomography (HRCT), will be recruited from our outpatient clinic of Chang Gung Memorial Hospital with written informed consent. The inclusion and exclusion criteria are described above.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. willing to sign a written consent form\n2. Male and female subjects with bronchiectasis diagnosed by high-resolution computed tomography\n3. willing to accept 6-minute exercise pulmonary function test and blood draw\n4. Men and women over the age of 20\n5. Has undergone chest computed tomography and bone density examination in the recent five years\n\nExclusion Criteria:\n\n1. pregnant women or lactating women\n2. asthma, lung resection history before the screening period\n3. active Tuberculosis infection\n4. Have received oral steroid treatment within 30 days\n5. current acute attack or clinical symptoms instability of bronchiectasis'}, 'identificationModule': {'nctId': 'NCT03467035', 'briefTitle': 'Role of NLRP3 Inflammasone and Hypoxia in the Severity of Osteoporosis in Patients With Bronchiectasis', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Role of NLRP3 Inflammasone and Hypoxia in the Severity of Osteoporosis in Patients With Bronchiectasis', 'orgStudyIdInfo': {'id': '201701317A3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'desaturation', 'description': 'ΔSpO2 \\>10% or lowest SpO2\\<90 during baseline six minute walk test\n\nCheck serum level of inflammasone, such as IL-1beta, TGF-beta TRT-PCR for PBMC', 'interventionNames': ['Other: Inflammasone']}, {'label': 'non-desaturation', 'description': 'ΔSpO2 \\<10% and lowest SpO2\\>90 during baseline six minute walk test\n\nCheck serum level of inflammasone, such as IL-1beta, TGF-beta TRT-PCR for PBMC', 'interventionNames': ['Other: Inflammasone']}], 'interventions': [{'name': 'Inflammasone', 'type': 'OTHER', 'description': 'Serum level of cytokine and RT-PCR for PBMC', 'armGroupLabels': ['desaturation', 'non-desaturation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Hung-Yu Huang, MD', 'role': 'CONTACT', 'email': 'b9202071@cgmh.org.tw', 'phone': '033281200', 'phoneExt': '8470'}], 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Hung-Yu Huang, MD', 'role': 'CONTACT', 'email': 'b9202071@cgmh.org.tw', 'phone': '033281200', 'phoneExt': '8470'}, {'name': 'Chun-Hua Wang, MD', 'role': 'CONTACT', 'email': 'wchunhua@ms7.hinet.net', 'phone': '033281200', 'phoneExt': '8468'}], 'overallOfficials': [{'name': 'Chun-Hua Wang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chang Chung Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chun-Hua Wang, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Chun-Hua Wang, MD', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}