Actively Recruiting
A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of BI 1291583 2.5 mg Once Daily for up to 76 Weeks in Patients With Bronchiectasis The AIRTIVITY Study
Led by Boehringer Ingelheim · Updated on 2026-05-29
1755
Participants Needed
494
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a medicine called BI 1291583 in people aged 12 to under 18 and adults who have bronchiectasis, a lung condition that causes cough and sputum production. The study focuses on participants who have experienced flare-ups, or exacerbations, of their condition. It is a Phase III, randomized, double-blind, placebo-controlled trial designed to compare BI 1291583 with a placebo to understand its impact on bronchiectasis symptoms and flare-up frequency. Participants are randomly assigned to one of two groups one group takes BI 1291583 tablets and the other takes placebo tablets that look the same but contain no medicine. They take one tablet daily for up to 76 weeks about 1 year and 6 months. The study includes up to 10 clinic visits and around 13 phone calls over a total participation period of up to 1 year and 8 months. During the study, participants regularly use a smartphone diary to record their bronchiectasis symptoms, and study doctors monitor their health, noting any flare-ups and unwanted effects. The main outcome measured is the yearly rate of pulmonary exacerbations. Additional assessments include quality of life, lung function tests, and time to first severe exacerbation. Regular health checks ensure participant safety throughout the trial.
CONDITIONS
Brief Title
The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants
- Women able to have children must use highly effective birth control methods
- Signed informed consent and assent if applicable
- Age 12 years or older
- Adolescents must weigh at least 35 kg at first visit
- Clinical history and investigator-confirmed diagnosis of bronchiectasis by CT scan (scan not older than 5 years or new scan during screening)
- Adults able to produce sputum for Pseudomonas aeruginosa assessment during screening
- History of pulmonary exacerbations requiring antibiotic treatment: at least 2 exacerbations in past 12 months, or at least 1 exacerbation plus high symptom burden (adults or adolescents as defined)
- Participants on chronic antibiotics or CFTR modulator therapy must have had at least one exacerbation since starting these treatments
You will not qualify if you...
- New or newly diagnosed immunodeficiency condition within 1 year before randomization
- Allergic bronchopulmonary aspergillosis requiring treatment
- Tuberculosis or non-tuberculosis mycobacterial infection requiring treatment
- Any medical or lab findings posing risk to participation as judged by investigator
- Acute respiratory infection or ongoing pulmonary exacerbation at screening unless recovered
- Relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal, or other disorders posing risk
- Major surgery within 6 weeks before randomization or scheduled during trial
- Active or suspected malignancy or history within 5 years except certain skin or cervical cancers
- Moderate or severe liver disease
- Poor kidney function (eGFR <30 mL/min) at screening
- Previous treatment with a dipeptidyl peptidase-1 (DPP1) inhibitor except placebo-only exposure in prior studies
- Other exclusion criteria as applicable per investigator's judgment
Research Team
B
Boehringer Ingelheim
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