BI 1291583の異なる用量が気管支拡張症の患者に効果があるかどうかを検証する研究
基本情報
- NCT ID
- NCT05238675
- ステータス
- 完了
- 試験のフェーズ
- 第2相
- 試験タイプ
- 介入
- 目標被験者数
- 322
- 治験依頼者名
- Boehringer Ingelheim
概要
This study is open to adults with bronchiectasis. People can join the study if they produce sputum and have a history of flare-ups (also called exacerbations). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 4 groups randomly, which means by chance. Participants in groups 1, 2, and 3 get different doses of BI 1291583. Participants in group 4 get placebo. Placebo tablets look like BI 1291583 tablets, but do not contain any medicine. Participants take the tablets once a day. Participants are in the study for between 6 months and 1 year. During this time, they visit the study site about 10 times and get about 5 phone calls from the site staff. The doctors document when participants experience flare-ups during the study. The time to the first flare-ups is compared between the treatment groups. Doctors also regularly check participants' health and take note of any unwanted effects.
対象疾患
介入
依頼者(Sponsor)
実施施設 (13)
佐賀大学医学部附属病院
Saga, Saga, Japan
Matsusaka City Hospital
Mie, Matsusaka, Japan
名古屋大学医学部附属病院
Aichi, Nagoya, Japan
福岡大学病院
Fukuoka, Fukuoka, Japan
新潟大学医歯学総合病院
Niigata, Niigata, Japan
北里大学 北里研究所病院
Tokyo, Minato-ku, Japan
九州大学病院
Fukuoka, Fukuoka, Japan
Ibarakihigashi National Hospial
Ibaraki, Naka-gun, Japan
独立行政法人国立病院機構 大阪刀根山医療センター
Osaka, Toyonaka, Japan
公益財団法人結核予防会 複十字病院
Tokyo, Kiyose, Japan
鹿児島大学病院
Kagoshima, Kagoshima, Japan
医療法人亀田内科クリニック
Chiba, Kamogawa, Japan
弘前大学医学部附属病院
Aomori, Hirosaki, Japan