- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00741572
Individual Sensitivity for Interstitial Lung Diseases
Interstitial lung diseases (ILD) is a collective noun for various chronic lung diseases, including sarcoidosis and idiopathic lung fibrosis (IPF). Sarcoidosis is a multi-systemic disease that includes damage to the lungs in 90% of the patients. Generally, the disease can be described as a systemic, granulomatous and antigen-driven disorder. IPF is a disease of only the lungs, in which an unknown cause induces a strong inflammation reaction leading to acute lung damage that ultimately results in the formation of scar tissue and stiffness of the lungs.
Unfortunately, the exact cause of ILD is still unknown. It is suggested that environmental and work-related exposure to various triggers can exert an effect on the course of the diseases. Examples of such triggers include bacteria, organic agents such as pollen and cotton dust and inorganic agents like metals and talc. Due to this unknown cause, it is difficult to treat ILD. Consequently, the current guideline is no medication or anti-inflammatory agents in severe cases. Unfortunately, this therapy is not completely effective.
Triggers that are suggested to cause ILD can exert their effects via various mechanisms. On the one hand, they can induce an inflammatory reaction as we recently demonstrated for various triggers including instillation material and sicila. During such an inflammatory reaction, cytokines are released that can induce oxidative stress, i.e. an imbalance between the formation of and the protection against reactive oxygen species (ROS). On the other hand, ILD-inducing triggers may directly cause an increased ROS production that subsequently can evoke an inflammatory reaction.
The objective of the current study is to investigate the individual sensitivity for the development of ILD after exposure to various triggers. Main focus will be the differences in the formation of and the protection against ROS as well as the occurring inflammatory reaction after exposure to such triggers.
Furthermore, a simple blood test will be developed to study and eventually even predict the individual reaction of subjects to various triggers.
Finally, to fully characterize the development of ILD after exposure to various triggers, the exhaled air of patients will be studied in order to identify specific markers of oxidative stress and damage.
연구 개요
상태
정황
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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-
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Maastricht, 네덜란드
- Maastricht University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Participants in this study include both men and women, who are 18 years of age or older and diagnosed with ILD using lung biopsy, X ray or BALF (broncho-alveolar lavage fluid) analysis and are either treated for this with anti-inflammatory agents or not. There's no maximum age set for this study since ILD can occur at all ages. Additional criteria are non smoking, no pregnancy or lactation and no use of vitamins or nutritional supplements.
The inclusion of both treated and untreated patients enables us to study the effectiveness of anti-inflammatory agents on a larger scale.
설명
Inclusion Criteria:
- ILD diagnosis confirmed by lung biopsy, X ray or BALF analysis
Exclusion Criteria:
- smoking
- pregnancy or lactation
- use of vitamins or nutritional supplements
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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1
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2
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
differences in the production of and the protection against ROS
기간: 6 hours
|
6 hours
|
differences in the occurring inflammatory reaction
기간: 6 hours
|
6 hours
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
differences in the presence of so-called volatile organic compounds (VOCs) in the exhaled air
기간: 0 hour
|
0 hour
|
공동 작업자 및 조사자
수사관
- 연구 의자: Aalt Bast, PhD, Maastricht University
- 수석 연구원: Agnes W Boots, PhD, Maastricht University
- 연구 책임자: Marjolein Drent, PhD, MD, Maastricht University Medical Center
간행물 및 유용한 링크
유용한 링크
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 (실제)
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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