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BronchiectasisDigital healthChildren's healthDrugPhase 3

What this study is

This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had 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 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months.

Participants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants regularly complete a diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.

What's being tested

  • BI 1291583

    Intervention · DRUG

    BI 1291583

  • Placebo matching BI 1291583

    Intervention · DRUG

    Placebo matching BI 1291583

Study details

Official title
A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of BI 1291583 2.5 mg Administered Once Daily for up to 76 Weeks in Patients With Bronchiectasis (The AIRTIVITY™ Study)
Sponsor
Boehringer Ingelheim
Conditions
Bronchiectasis
Enrolling
1,755 people
Starts
2025-06-09
Est. completion
2027-12-20
Design
Quadruple-blind, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗