A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™)
2상
완료
NCT05865886
| 대상 질환 | Cystic Fibrosis, Bronchiectasis |
|---|
| 임상 단계 | 2상 |
|---|
| 스폰서 | Boehringer Ingelheim |
|---|
| 상태 | 완료 |
|---|
| 참여자 수 | 22 명 |
|---|
| 중재(약물) | BI 1291583, Placebo to BI 1291583 |
|---|
| 시작일 | 2024년 4월 5일 |
|---|
| 완료일 | 2024년 10월 7일 |
|---|
| 결과 공개일 | 2025년 11월 18일 |
|---|
요약
This study is open to adults aged 18 years and older with cystic fibrosis bronchiectasis. The purpose of this study is to find out whether a medicine called BI 1291583 is tolerated by people with cystic fibrosis bronchiectasis. Participants are put randomly into 2 groups. One group takes BI 1291583 tablets and the other group takes placebo tablets. Placebo tablets look like BI 1291583 tablets but do not contain any medicine. Participants in both groups take 1 tablet once a day for 12 weeks. Participants have twice the chance of being placed in the BI 1291583 group than in the placebo group. Participants are in the study for about 6 months. During this time, they visit the study site 7 times. At the visits, the doctors check the health of the participants and note any health problems that could have been caused by BI 1291583.
Occurrence of Any Treatment Emergent Adverse Events
From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks. · Percentage of participants
| Placebo | 85.7 Percentage of participants |
|---|
| BI 1291583 5 mg | 93.3 Percentage of participants |
|---|
BENITIONS에서 보기
ClinicalTrials.gov 원문 보기
전체 임상
이 페이지는 ClinicalTrials.gov의 공개 데이터를 정리한 것입니다. 의학적 조언이 아니며 투자 권유나 자문도 아닙니다. 반드시 전문의와 상담하세요.