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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

Bronchiectasis

介入

BI 1291583(DRUG)
Placebo(DRUG)

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