BENITIONSClinical Trial Intelligence

A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™)

2期 已完成 NCT05865886

适应症Cystic Fibrosis, Bronchiectasis
分期2期
申办方Boehringer Ingelheim
状态已完成
受试者人数22 人
干预(药物)BI 1291583, Placebo to BI 1291583
开始日期2024年4月5日
完成日期2024年10月7日
结果公布日2025年11月18日

摘要

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

Placebo85.7 Percentage of participants
BI 1291583 5 mg93.3 Percentage of participants

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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。