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NCT06872892
The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis
Phase 3 trial testing BI 1291583 in Bronchiectasis in 1,755 participants. Currently enrolling.
14 September 2028
Quick facts
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 1,755 |
| Start date | 9 June 2025 |
| Primary completion | 14 September 2028 |
| Estimated completion | 12 October 2028 |
| Sites | 495 locations across Hong Kong, Italy, Finland, Japan, Malaysia, Kazakhstan, Taiwan, Ireland |
Drugs / interventions tested
- BI 1291583 — full drug profile →
- Placebo matching BI 1291583 — full drug profile →
Conditions studied
- Bronchiectasis — all drugs for Bronchiectasis →
Sponsor
Boehringer Ingelheim — full company profile →
Who can join
12 and older, any sex, with Bronchiectasis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Tackling Neutrophilic Inflammation in Bronchiectasis: From Macrolides to Cathepsin C Inhibitors.
Gramegna A, Premuda C, Putti G, Piedepalumbo FV, et al · · 2026 · PMID 41993889 · DOI 10.2147/jir.s558745 -
Bronchiectasis Treatment Goals, Unmet Needs, and Emerging Therapies: A Podcast.
Flume PA, Maselli DJ. · · 2026 · PMID 41269659 · DOI 10.1007/s41030-025-00330-1 -
Breaking boundaries or a small piece of the puzzle: can CFTR modulators transform bronchiectasis care?
Graeber SY, Frost F. · · 2025 · PMID 41189579 · DOI 10.1183/23120541.00593-2025 -
Dipeptidyl peptidase 1 inhibitors for inflammatory respiratory diseases: mechanisms, clinical trials, and therapeutic prospects.
Zhang D, Zhang W, Hu P, Zhang W. · · 2025 · PMID 40918524 · DOI 10.3389/fphar.2025.1656316
Verify or expand the search:
- PubMed search for NCT06872892
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of BI 1291583
Trials testing the same drug.
- NCT07023354 — A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems · Phase 1 · recruiting
- NCT06917872 — A Study in Healthy People to Test Whether Erythromycin Influences the Amount of BI 1291583 in the Blood · Phase 1 · completed
- NCT06791187 — A Study in Healthy People to Test Whether BI 1291583 Influences the Amount of Dabigatran in the Body · Phase 1 · completed
- NCT06631417 — A Study in Healthy People to Test How 2 Different Doses of BI 1291583 Are Taken up in the Body When Given in 3 Different · Phase 1 · completed
- NCT05865886 — A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™) · Phase 2 · completed
Other recruiting trials for Bronchiectasis
Currently open trials in the same condition.
- NCT07283497 — Itraconazole Therapy In Bronchiectasis With Airway Mold · Phase 4 · recruiting
- NCT07188675 — Functional Inspiratory Training in Bronchiectasis · NA · recruiting
- NCT06897761 — Development of an Interactive Digital Respiratory Game and Device and Investigation of Its Effectiveness in Children Wit · NA · recruiting
- NCT07147803 — Sleep Quality in Patients With Non-cystic Fibrosis Bronchiectasis · active not recruiting
- NCT07274631 — A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine · recruiting
Other Boehringer Ingelheim trials
Trials by the same sponsor.
- NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
- NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
- NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
- NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
- NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06872892 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
- Last refreshed: 15 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06872892.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing