Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-01-12 @ 7:19 AM
Study NCT ID:
NCT02881502
Status:
UNKNOWN
Last Update Posted:
2016-08-29
First Post:
2016-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of Relationship Between Granulocyte Activation, HDAC2 and Severe 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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-23', 'studyFirstSubmitDate': '2016-07-15', 'studyFirstSubmitQcDate': '2016-08-23', 'lastUpdatePostDateStruct': {'date': '2016-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence of clinically definite severe asthma confirmed by the plasma concentration of blood related indexes(MPO、MMP-9、NE、ECP、HDAC2)', 'timeFrame': 'one year', 'description': 'Compare the difference was not statistically significant of the different groups by testing the concentration of blood related indicators of subjects'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['granulocyte activation', 'HDAC2', 'severe asthma'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'Program： Clinical Study of Relationship Between Granulocyte Activation, HDAC2 and Severe Asthma Aim：The early prediction of severe asthma, early intervention on the disease, reduce the family and the national finance.\n\ndesign:This study is a single center randomized controlled trial designed by the Department of respiratory medicine, Xijing Hospital, as the main research unit.Compare the case group(severe asthma group and mild-and-moderate asthma group) and control group(healthy control group) by detecting the activity of MPO、NE、MMP-9 and ECP in the peripheral blood and the activity of HDAC2 in PBMCs of patients.\n\ncase:60\n\nCase selection:\n\nInclusion criteria: age 18-75 years old; diagnosis of asthma was clear; informed consent was signed.\n\nExclusion criteria: poor compliance; cognitive ability is low; psychiatric disorders need to be combined with psychotropic medication.', 'detailedDescription': 'Application of SPSS 19 statistical software. Measurement data were expressed as mean ± standard deviation.\n\nFirst the data is normality tested and homogeneity of variance tested, according to the measurement data of normal distribution by SNK single factor analysis of variance; does not conform to the normal distribution of measurement data, using the Kruskal Wallis non parametric test. P \\< 0.05 for the difference was statistically significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'outpatients and the students', 'healthyVolunteers': True, 'eligibilityCriteria': 'inclusion criteria: healthy control group：\n\n* Mainly from students,\n* family members of patients without chronic lung disease,\n* healthy population,\n* age 18-75 years old, the gender is not limited. case group：\n* The patient has been diagnosed with asthma in the outpatient clinic. The diagnostic criteria are in accordance with the Guidelines for Prevention and Treatment of Bronchial Asthma in the respiratory disease branch of the Chinese Medical Association.\n\nIn the past 1 year need guidelines of global asthma record instrument 4-5 drug treatment of asthma \\[high dose inhaled corticosteroid with long-acting beta2 receptor agonist or leukotriene modifiers / theophylline or systemic hormone therapy is more than or equal to 50% of the time, in order to prevent into uncontrolled asthma, or even in the treatment is to control asthma patients for severe asthma.\n\nexclusion criteria：\n\n* Poor treatment compliance, or low cognitive ability to impact the self rating scale ;\n* There are serious heart, liver, renal dysfunction, or other infectious diseases ;\n* The individual who refuse to sign the informed consent.'}, 'identificationModule': {'nctId': 'NCT02881502', 'briefTitle': 'Clinical Study of Relationship Between Granulocyte Activation, HDAC2 and Severe Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'orgStudyIdInfo': {'id': 'Haiqin Guo'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'healthy control group', 'description': 'Mainly from students, family members of patients without chronic lung disease, healthy population, age 18-75 years old, the gender is not limited.'}, {'label': 'mild and moderate asthma group', 'description': 'Patients diagnosed with asthma in the outpatient clinic, in accordance with the inclusion criteria and exclusion criteria.'}, {'label': 'severe asthma group', 'description': 'Outpatient patients with severe asthma diagnosis, in accordance with the inclusion criteria and exclusion criteria.', 'interventionNames': ['Other: severe asthma group']}], 'interventions': [{'name': 'severe asthma group', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['severe asthma group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '780032', 'city': 'Xian', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guo H qin, graduate', 'role': 'CONTACT', 'email': 'hqgsunshine@163.com', 'phone': '18194278935', 'phoneExt': '029'}], 'facility': 'XijingH'}], 'centralContacts': [{'name': 'Guo H qin, Graduate', 'role': 'CONTACT', 'email': 'hqgsunshine@163.com', 'phone': '18194278935', 'phoneExt': '029'}], 'overallOfficials': [{'name': 'Wu C gui, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Xijing Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master Degree Candidate,Student of Respiratory Medicine', 'investigatorFullName': 'Haiqin Guo', 'investigatorAffiliation': 'Xijing Hospital'}}}}