- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02881502
Clinical Study of Relationship Between Granulocyte Activation, HDAC2 and Severe Asthma
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.
design: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.
case:60
Case selection:
Inclusion criteria: age 18-75 years old; diagnosis of asthma was clear; informed consent was signed.
Exclusion criteria: poor compliance; cognitive ability is low; psychiatric disorders need to be combined with psychotropic medication.
연구 개요
상세 설명
Application of SPSS 19 statistical software. Measurement data were expressed as mean ± standard deviation.
First 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.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Shanxi
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Xian, Shanxi, 중국, 780032
- 모병
- XijingH
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연락하다:
- Guo H qin, graduate
- 전화번호: 029 18194278935
- 이메일: hqgsunshine@163.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
inclusion criteria: healthy control group:
- Mainly from students,
- family members of patients without chronic lung disease,
- healthy population,
- age 18-75 years old, the gender is not limited. case group:
- 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.
In 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.
exclusion criteria:
- Poor treatment compliance, or low cognitive ability to impact the self rating scale ;
- There are serious heart, liver, renal dysfunction, or other infectious diseases ;
- The individual who refuse to sign the informed consent.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
healthy control group
Mainly from students, family members of patients without chronic lung disease, healthy population, age 18-75 years old, the gender is not limited.
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mild and moderate asthma group
Patients diagnosed with asthma in the outpatient clinic, in accordance with the inclusion criteria and exclusion criteria.
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severe asthma group
Outpatient patients with severe asthma diagnosis, in accordance with the inclusion criteria and exclusion criteria.
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No intervention
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Evidence of clinically definite severe asthma confirmed by the plasma concentration of blood related indexes(MPO、MMP-9、NE、ECP、HDAC2)
기간: one year
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Compare the difference was not statistically significant of the different groups by testing the concentration of blood related indicators of subjects
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one year
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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Wu C gui, professor, Xijing Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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