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

Phase 3

Recruiting

• Conditions: Bronchiectasis
• Interventions: Drug: BI 1291583; Drug: Placebo matching BI 1291583

• Registration Number: NCT06872892
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This study is open to adults 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 complete a daily 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-03-07
• Study First Posted: 2025-03-12
• Study Start: 2025-06-09
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-25
• Last Update Posted: 2025-07-28
• Primary Completion: 2028-09-14
• Study Completion: 2028-10-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1680

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment arm	BI 1291583	-
Placebo arm	Placebo matching BI 1291583	-

Primary Outcome Measures

Name	Time	Method
Annualized rate of pulmonary exacerbations (number of events per person year) up to Week 76	up to 76 weeks

Secondary Outcome Measures

Name	Time	Method
Time to first pulmonary exacerbation up to Week 76	up to 76 weeks
Absolute change from baseline in post-bronchodilator Forced Expiratory Volume in the first second (FEV1) %pred at Week 52	at baseline, at week 52
Absolute change from baseline in Quality of Life Questionnaire - Bronchiectasis (QOL-B) respiratory symptoms domain score at Week 52	at baseline, at week 52	The QOL-B is a patient reported outcome (PRO) measure assessing symptoms, functioning and health-related quality of life of patients with bronchiectasis. It consists of 37 items covering the following domains: respiratory symptoms, physical functioning, vitality, role functioning, health perception, emotional functioning, social functioning, and treatment burden.; All items are rated on a 4-point response scale ranging from 'a lot' to 'not at all' with the recall period 'the previous week'. Domain scores are generated ranging from 0 to 100, with higher scores indicating less symptom burden, better functioning, and higher health-related quality of life respectively.
Absolute change from baseline in post-bronchodilator Forced Vital Capacity (FVC) %pred at Week 52	at baseline, at week 52
Annualized rate of severe pulmonary exacerbations up to Week 76	up to 76 weeks
Time to first severe pulmonary exacerbation up to Week 76	up to 76 weeks

Trial Locations

Locations (475)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Providence Medical Group Alaska; 🇺🇸 Anchorage, Alaska, United States

Dignity Health, St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States

University of Arizona; 🇺🇸 Tucson, Arizona, United States

Newport Native MD, Inc; 🇺🇸 Newport Beach, California, United States

Paradigm Clinical Research - Redding; 🇺🇸 Redding, California, United States

University of California Davis; 🇺🇸 Sacramento, California, United States

Ventura County Medical Center; 🇺🇸 Ventura, California, United States

National Jewish Health; 🇺🇸 Denver, Colorado, United States

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

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