- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02495597
LCI and Bronchial Inflammation in Patients With BO (FRABO-02)
Lung Clearance Index (LCI) and Bronchial Inflammation in Patients With Bronchiolitis Obliterans (BO)
연구 개요
상세 설명
The purpose of this study is to compare lung function values with the Lung clearance index of 20 Patients with Bronchiolitis obliterans aged between 6 up to 28 years. Further we aim to compare the bronchial Inflammation between the patients and a reference group with similar age conditions to determine possible outcome-parameters for following interventional studies.
The sputum samples will be processed and quantitatively analyzed to get a profile of the cytological composition.
(Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction (PCR) (qRT-PCR) and by cytometric bead assay (CBA).)
Methods and Work Programme:
- Measurement of nitric oxide in expired air (FeNO)
- Lung function testing with spirometry and body plethysmography
- Lung clearance index (LCI)
- Bronchodilation
- Blood test: blood count, CRP, RAST, serum inflammatory mediators, (genetic markers of the non-specific pulmonary defense system)
- Induced sputum for inflammatory mediators and microbiological investigations
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Hessen
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Frankfurt am Main, Hessen, 독일, 60590
- Children's Hospital, Goethe-University
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- informed consent
- between 6 and 28 years of age
Known Bronchiolitis obliterans
- no Bronchiolitis obliterans(depending on the study group)
- Ability to perform lung function tests and inhalation
Exclusion Criteria:
- Acute illness with systemic or bronchial inflammation
- every chronic condition or infection (eg HIV, tuberculosis, malignancy)
- pregnancy
- known alcohol and/ or drug abuse
- Inability to understand the extent and scope of the study
- Participation in another study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
주제-그룹
폐쇄세기관지염 진단을 받은 의사로 고통받는 환자
|
|
대조군
주제 그룹과 일치하는 연령 및 성별
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
LCI compared to RV/TLC%-pred.
기간: during Visit 1 (single day, single observation)
|
Correlation of these lung function Parameters in patients with BO compared to healthy controls
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during Visit 1 (single day, single observation)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
change of sputum cell count over time (percentage of neutrophils)
기간: during Visit 1 (single day, single observation)
|
induced sputum will be analyzed for different cellular components such as alveolar macrophages, neutrophils, lymphocytes and others.
Epithelial cells will be excluded
|
during Visit 1 (single day, single observation)
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Comparison of low CrP
기간: during Visit 1 (single day, single observation)
|
serum parameter for systemic inflammation
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during Visit 1 (single day, single observation)
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FVC (%-pred.)
기간: during Visit 1 (single day, single observation)
|
To compare FVC (%-pred.)of
patients suffering from BO with FVC (%-pred.)of a healthy control group
|
during Visit 1 (single day, single observation)
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FEV1 (%-pred.)
기간: during Visit 1 (single day, single observation)
|
To compare FEV1 (%-pred.)of
patients suffering from BO withFEV1 (%-pred.)of a healthy control group
|
during Visit 1 (single day, single observation)
|
Tiffeneau-Index
기간: during Visit 1 (single day, single observation)
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To compare Tiffeneau-Index of patients suffering from BO with Tiffeneau-Index of a healthy control group
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during Visit 1 (single day, single observation)
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sRtot (%-pred.)
기간: during Visit 1 (single day, single observation)
|
To compare sRtot (%-pred.) of patients suffering from BO with sRtot (%-pred.) of a healthy control group
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during Visit 1 (single day, single observation)
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RV/TLC (%-pred.)
기간: during Visit 1 (single day, single observation)
|
To compare RV/TLC (%-pred.) of patients suffering from BO with RV/TLC (%-pred.) of a healthy control group
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during Visit 1 (single day, single observation)
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IL-6 (pg/ml)
기간: during Visit 1 (single day, single observation)
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comparing IL-6 in Serum of patients with BO with healthy controls
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during Visit 1 (single day, single observation)
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IL-8 (pg/ml)
기간: during Visit 1 (single day, single observation)1
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comparing IL-8 in Serum of patients with BO with healthy controls
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during Visit 1 (single day, single observation)1
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IL-17 (pg/ml)
기간: during Visit 1 (single day, single observation)
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comparing IL-17 in Serum of patients with BO with healthy controls
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during Visit 1 (single day, single observation)
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IL-6 (mRNA delta-delta-ct)
기간: during Visit 1 (single day, single observation)
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compare IL-6 mRNA in Sputum cells of patients with BO with healthy controls
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during Visit 1 (single day, single observation)
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IL-8 (mRNA delta-delta-ct)
기간: during Visit 1
|
compare IL-8 mRNA in Sputum cells of patients with BO with healthy controls
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during Visit 1
|
IL-17 (mRNA delta-delta-ct)
기간: during Visit 1 (single day, single observation)
|
compare IL-17 mRNA in Sputum cells of patients with BO with healthy controls
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during Visit 1 (single day, single observation)
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Percentage of FOXP3 positive cells in Sputum
기간: during Visit 1 (single day, single observation)
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compare percentage of FOXP3 positive cells in Sputum cells of patients with BO with healthy controls
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during Visit 1 (single day, single observation)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Martin Rosewich, MD, Johann Wolfgang Goethe University Hospital
간행물 및 유용한 링크
유용한 링크
- Kurland G, Michelson P. Bronchiolitis obliterans in children. Pediatr Pulmonol. 2005 Mar;39(3):193-208. Review
- Smith KJ, Fan LL. Insights into post-infectious bronchiolitis obliterans in children. Thorax. 2006 Jun;61(6):462-3.
- Pichler M, Herrmann G, Schmidt H, Ahrens P, Zielen S. Persistent adenoviral infection and chronic obstructive bronchitis in children: is there a link? Pediatr Pulmonol. 2001 Nov;32(5):367-71.
- Pichler MN, Reichenbach J, Schmidt H, Herrmann G, Zielen S. Severe adenovirus bronchiolitis in children. Acta Paediatr. 2000 Nov;89(11):1387-9.
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. .
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