- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02558127
Asthma With Hypersecretion-associated Gene for Cystic Fibrosis (CF-asthma)
Asthma With Hypersecretion-associated Gene for Cystic Fibrosis Clinical, Inflammatory and Genetics Characterization
연구 개요
상세 설명
Primary objective:
Determine the presence of genetic variants (mutations and / or polymorphisms) of the CFTR gene in patients with asthma with or without bronchial mucus hypersecretion.
Secondary objectives:
To identify genetic variants (mutations and / or polymorphisms) of the most common CFTR gene in the asthmatic population. -To define the inflammatory phenotype of asthma with bronchial mucus hypersecretion. -To compare the severity, control, quality of life and frequency of exacerbations of asthma patients with or without bronchial mucus hypersecretion
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Barcelona, 스페인, 08041
- Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.
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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: Asthmatic patients aged between 18 and 80 years.They have not a respiratory infection in the last month.
Criteria for exclusion: Presence of other lung disease, Sequelae of tuberculosis, Bronchiectasis (large, secondary to a different asthma respiratory disease), Cystic fibrosis, Residual pleural disease, Interstitial diseases, Severe comorbidity, Patients with oral corticosteroids or other immunomodulators by causes other than asthma.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 컨트롤
- 시간 관점: 단면
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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50 asthma patients
50 asthma patients with bronchial mucus hypersecretion
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Patients with inclusion criteria, following examinations: a study of lung function measurement of the fraction of nitric oxide in exhaled air, induced sputum, sputum, and extraction of peripheral venous blood for Study of genetic variants in the CFTR gene,skin prick test .
The number of eosinophils in peripheral blood by automated cell counting and Total IgE by ELISA were measured.
Furthermore, the level of asthma control be assessed by validated symptom questionnaire Asthma Control Test, quality of life is determined by the MiniAQLQ questionnaire.
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asthma patients
50 asthma patients without bronchial mucus hypersecretion
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Patients with inclusion criteria, following examinations: a study of lung function measurement of the fraction of nitric oxide in exhaled air, induced sputum, sputum, and extraction of peripheral venous blood for Study of genetic variants in the CFTR gene,skin prick test .
The number of eosinophils in peripheral blood by automated cell counting and Total IgE by ELISA were measured.
Furthermore, the level of asthma control be assessed by validated symptom questionnaire Asthma Control Test, quality of life is determined by the MiniAQLQ questionnaire.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Number of asthmatic patients CF carriers
기간: 12 months
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12 months
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Noncarriers number of asthmatics
기간: 12 months
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12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Astrid Crespo, Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau
간행물 및 유용한 링크
일반 간행물
- Goodwin J, Spitale N, Yaghi A, Dolovich M, Nair P. Cystic fibrosis transmembrane conductance regulator gene abnormalities in patients with asthma and recurrent neutrophilic bronchitis. Can Respir J. 2012 Jan-Feb;19(1):46-8. doi: 10.1155/2012/546702.
- Dahl M, Tybjaerg-Hansen A, Lange P, Nordestgaard BG. DeltaF508 heterozygosity in cystic fibrosis and susceptibility to asthma. Lancet. 1998 Jun 27;351(9120):1911-3. doi: 10.1016/s0140-6736(97)11419-2. Erratum In: Lancet 1998 Oct 10;352(9135):1230.
- Dahl M, Nordestgaard BG, Lange P, Tybjaerg-Hansen A. Fifteen-year follow-up of pulmonary function in individuals heterozygous for the cystic fibrosis phenylalanine-508 deletion. J Allergy Clin Immunol. 2001 May;107(5):818-23. doi: 10.1067/mai.2001.114117.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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. .