- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02809560
Detection of Cav1 Calcium Channels in Inflammatory Cells of Asthmatic Children (CAVASTHME)
Asthma affects about 10% of children and 6% of adults in industrialized countries. Lymphocytes (L) Th2, a T cell population (LT) producing interleukin (IL) -4, 5 and 13 are broadly involved in this pathology in experimental models and in humans. Many studies show that the signaling pathways activated by the commitment of T receiver differ depending LT. The identification of specific signaling pathways links to Th2 offer new therapeutic approaches. Precedent study showed that mouse Th2 selectively expressed related to calcium channels sensitive channels Cav1 voltage, normally found in excitable cells where they are defined as receivers dihydropyridine (DHP).
The goal of the present study is to show the presence of Cav1 channels in inflammatory cells in allergic asthmatics and show overexpression of these channels in the peripheral blood mononuclear cells from asthmatic subjects before and / or after stimulation with the TCR in comparison with controls.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
For Asthmatic children arm :
- Girl not in childbearing potential or taking contraceptive treatment
- Asthma diagnosis in at least 6 months as defined by clinical symptoms (expiratory dyspnea, wheezing, sibilance) and respiratory function (reversibility of VEMS at least 12% after salbutamol administration)
- Allergologic tests positives to airborne allergens : positive prick test and/or specific IgE > 0,35 kU/L for at least one allergen
- Asthma severity between mild to moderate based on Global initiative for asthma classification during more than one month with inhaled corticotherapies +/- long term action beta -mimetic long compounds (salmeterol, formoterol)
- Patient insured with a social security scheme
For control children arm :
- Girl not in childbearing potential or taking contraceptive treatment
- No medical history of asthma
- No medical history of allergy or symptoms of allergy on skin (atopic dermatitis), respiratory tract (rhino-conjunctivitis, asthma) or food allergy
Exclusion Criteria:
For both arms:
- Chronic respiratory pathology : known occlusive or restrictive respiratory syndrome like interstitial lung disease, neuromuscular disease, mucoviscidoses, respiratory tract abnormalities with cough, dyspnea or digital hippocratism.
- History of pulmonary or nose and throat infectious disease during last 4 months
- Parasitic disease non treated during last 3 months
- Dyspnea during the inclusion
- Systemic corticotherapy during the last 3 months before inclusion
- Immunosuppressive therapy during the last 3 months before inclusion
- Diabeta
- Disease causing immune disorder
- Infection during inclusion
- Participation to another study witch implies medical treatment during last 3 months before inclusion
For asthmatic children arm :
- Chronic pulmonary pathology (excluding asthma)
- Asthma exacerbation during inclusion
- VEMS < 70% of normal range or VEMS < 70% of normal range after inhalation of serum (despite salbutamol administration)
- Patient unable to complete pulmonary function testing
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Asthmatic children
Induced sputum method using hypertonic serum
|
Collection of expectoration in sterile vial, conserved in ice all along the examination
|
|
가짜 비교기: Control children
Induced sputum method using hypertonic serum
|
Collection of expectoration in sterile vial, conserved in ice all along the examination
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Detection of sequence coding for Cav1 in cells as assessed by reverse transcription polymerase chain reaction
기간: Day 1
|
Day 1
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Presence of Cav1 channels as assessed by correlation between Cav1 expression and eosinophils in expectoration collection
기간: Day 1
|
Day 1
|
|
Presence of Cav1 channels as assessed by correlation between Cav1 expression and lymphocytes T in expectoration collection
기간: Day 1
|
Day 1
|
|
Comparison of CRTH2+ cells in total blood between asthmatic and control group
기간: Day 1
|
Day 1
|
|
Comparison of Cav1 channels and cytokines Th2 expression between asthmatic and control group before T-Cell receptor stimulation
기간: Day 1
|
Day 1
|
|
Comparison of Cav1 channels and cytokines Th2 expression between asthmatic and control group after T-Cell receptor stimulation
기간: Day 1
|
Day 1
|
공동 작업자 및 조사자
수사관
- 수석 연구원: François Brémont, MD, Hôpital des Enfants CHU Toulouse
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. .