The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis

Conditions

• Bronchiectasis

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BI 1291583 — DRUG
  BI 1291583
• Placebo matching BI 1291583 — DRUG
  Placebo matching BI 1291583

Study Details

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.

Key Dates

First listed

Mar 12, 2025

Start date

Jun 9, 2025

Status verified

Aug 2026

Primary completion

Jun 15, 2027

Completion

Dec 20, 2027

Study Design

Enrollment

1,755 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment arm
• Placebo Comparator: Placebo arm

Primary Outcome Measure

Annualised rate of adjudicated pulmonary exacerbations (number of events per person year) up to Week 76 [ Time Frame: up to 76 weeks ]

Central Contacts

• Boehringer Ingelheim
  1-800-243-0127
  [email protected]

Locations (80)

Find similar trials in Birmingham, AL

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