- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02806466
Risk Factors for Early Remodelling in Severe Asthma in Children (P'tit-ASTHME)
2016년 6월 15일 업데이트: University Hospital, Bordeaux
- Background: Asthma is a frequent disease characterized by bronchial hyperresponsiveness, inflammation and remodeling. Consistent epidemiological data indicate that outcome of asthma in adults may be determined in early childhood. This may be due to bronchial remodeling, an abnormal repair process that contributes to the development of poorly reversible airway narrowing. It appears very early in the natural history of the disease and involves increased mass of bronchial smooth muscle (BSM). The mechanism of such an increase has been related with an increase in smooth muscle cell proliferation. Recently, we have demonstrated that in severe asthma, BSM increased proliferation is induced by an enhanced mitochondrial biogenesis. Moreover, we have also shown that immature human, non-asthmatic airway smooth muscle cells (ASMC) proliferate to a greater extent than normal adult ASMC, in a similar fashion to adult asthmatic ASMC. Immature ASMC may thus have great potential to stimulate airway remodeling. We thus hypothesized that remodeling is an early process and certain characteristics of ASMC in severe preschool asthma may predispose such children to persistent remodeling with airway obstruction later in life.
- Purpose: To investigate prognostic factors of airway remodeling in preschool children, with special attention to ASMC proliferation (mitochondrial mass & biogenesis).
- Methods: In the initial phase of the project, 75 severe asthmatic preschool children (<5 yr) will be prospectively recruited from the "CHU de Bordeaux" and the "CHU de Toulouse" according to the "Haute Autorité de Santé" criteria. Inclusion visit will include written informed consent, asthma control evaluation, clinical examination, lung function testing (exhaled NO, plethysmography), prick tests, chest X Ray and blood sample for total IgE levels. Bronchial specimens from all subjects will be obtained by fiberoptic bronchoscopy at visit 2. Airway remodeling will be evaluated by morphological analysis. After smooth muscle mitochondria will be analyzed by electronic microscopy & immunoblotting. Comparison between the 2 groups will be performed by unpaired t tests for parametric data and x2-tests for non-parametric data. In the second phase of the project, patients will then be followed-up till the age of 7-10 yrs, when another bronchoscopy with biopsies will be performed.
연구 개요
연구 유형
중재적
등록 (실제)
67
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Aquitaine
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Bordeaux, Aquitaine, 프랑스, 33000
- CHU de Bordeaux
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Languedoc-Roussillon-Midi-Pyrénées
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Toulouse, Languedoc-Roussillon-Midi-Pyrénées, 프랑스, 31026
- Hôpital des Enfants
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
1년 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
Asthmatic children
- Parents (and possibly the child) who gave written informed consent.
- Affiliated with a social security scheme.
- Age from 1 to less than 5 years.
- Severe persistent asthma according to the criteria of the National Health Authority (Annex I) or NEW PROPOSED CRITERIA (adapted ATS (42)):
Major criteria (> 1) Asthma control in mild to moderate level requiring
- A continuous or semi continuous (≥ 50% of the year) by oral corticosteroids
- A treatment with high doses of inhaled corticosteroids (> 500 micrograms / day of Beclomethasone, or equivalent (> 400 micrograms / day of Budesonide,> 200 micrograms / day of Fluticasone) for at least 6 weeks.
And
minor criteria (> 2)
- The need for an additional daily treatment (β2-agonists, long-acting, theophylline, anti-leukotrienes)
- Symptoms that require taking daily or almost daily of β2-agonists of short action
- persistent obstruction (FEV <80% PEF variability> 20%) (If reliable spirometry, usually> 5 years of age)
- One or more seeking care in emergency / year
- At least three short courses of oral corticosteroids / year
- Rapid Increases caused by the decrease of 25% of the dose of oral corticosteroids or inhaled
- ATCD of severe acute asthma who put in life-threatening
Non-asthmatic children
Non asthmatic child with indication of endoscopy:
- Any endoscopy for a disease without acute or chronic inflammation in the biopsy area (≥1 to <5 years (1st part): congenital stridor, double aortic arch, foreign body removal inhaled, ...; ≥ 7 to ≤ 10 years ( 2nd component): inhaled foreign body removal, ...).
- Parents (and possibly the child) who gave written informed consent.
- Affiliated with a social security scheme.
Children not asthmatic postmortem (retrospective and prospective)
- Age from 1 to under 5 (1st part) or aged 7 to 10 years (2nd part) on the death
- Died without pulmonary pathology in the sampled area
Non asthmatic child with thoracic surgery:
- Age from 1 to under 5 (1st part) or aged 7 to 10 years (2nd part).
- Subject with pulmonary pathology, requiring thoracic surgery lobectomy, non-inflammatory in the sampled area.
- Parents (and possibly the child) who gave written informed consent.
- Affiliated with a social security scheme.
Exclusion Criteria:
Asthmatic children:
- Subject having a severe exacerbation of asthmatic disease requiring hospitalization in the 3 weeks preceding their inclusion.
- exclusion period on topic compared to another protocol.
- Subject with significant co-morbidity associated with asthma not of any nature whatsoever
- bronchial malformations (exclusion criterion ex post).
- Subject with a dental infection, or nasopharyngeal airway (viral or bacterial) with fever (> 39 ° C) in the 4 weeks preceding the survey.
- chronic viral infections (hepatitis, HIV).
- non-specific inclusion criteria to endoscopy:
- Review of hemostasis abnormal,
- Subject with a heart condition,
- Subject is not fasted for over 6 hours.
Children without asthma:
Non-asthmatic children with indication of endoscopy:
- asthma diagnosed by a doctor.
- exclusion period on topic compared to another protocol.
- Subject with significant co-morbidity associated with asthma not of any nature whatsoever.
- bronchial malformations (exclusion criterion ex post).
- Subject with a dental infection, or nasopharyngeal airway (viral or bacterial) with fever (> 39 ° C) in the 4 weeks preceding the survey.
- chronic viral infections (hepatitis, HIV).
- non-specific inclusion criteria to endoscopy:
- Review of hemostasis abnormal,
- Subject with a heart condition,
- Subject is not fasted for over 6 hours.
Children postmortem non-asthmatics:
- asthma diagnosed by a doctor.
- Subject with a dental infection, or nasopharyngeal airway (viral or bacterial) with fever (> 39 ° C) within 4 weeks before sampling of tissue.
- chronic viral infections (hepatitis, HIV).
Non-asthmatic children with thoracic surgery:
- asthma diagnosed by a doctor.
- exclusion period on topic compared to another protocol.
- Subject with a dental infection, or nasopharyngeal airway (viral or bacterial) with fever (> 39 ° C) within 4 weeks before sampling of tissue.
- chronic viral infections (hepatitis, HIV).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Asthmatic children
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가짜 비교기: Non-asthmatic children
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Evaluation of Airway remodeling (distance from the reticular membrane to the smooth muscle).
기간: 1 day
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1 day
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: MICHAEL FAYON, Professor, University Hospital, Bordeaux
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2012년 3월 1일
기본 완료 (실제)
2015년 11월 1일
연구 완료 (실제)
2015년 11월 1일
연구 등록 날짜
최초 제출
2016년 6월 15일
QC 기준을 충족하는 최초 제출
2016년 6월 15일
처음 게시됨 (추정)
2016년 6월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 6월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 6월 15일
마지막으로 확인됨
2016년 6월 1일
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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