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)

Date Added
March 13th, 2026
PRO Number
Pro00149097
Researcher
Lauren Sullivan

List of Studies

Keywords
Bronchiectasis
Summary

After years of research into bronchiectasis, the AIRTIVITY® Study is looking to see if an investigational medicine – designed to target the harmful inflammation that contributes to bronchiectasis – can help improve the lives of people living with the condition. The AIRTIVITY® Study was designed with input from bronchiectasis patient community representatives. Participants take part in this study for up to 1 year and 8 months. During this time, participants will be randomly assigned to receive either the investigational medicine (67% chance) or a placebo (33% chance). The study medicine will be provided as tablets to be taken once daily at home.

Institution
MUSC
Recruitment Contact
Rohini Rao
(843) 792-0965
recruitment@musc.edu

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Ensifentrine in Subjects with Non-Cystic Fibrosis Bronchiectasis

Date Added
February 12th, 2025
PRO Number
Pro00142401
Researcher
Lauren Sullivan

List of Studies

Keywords
Nontuberculous mycobacteria (NTM)
Summary

This trial is a study to evaluate the efficacy and safety of ensifentrine inhalation suspension administered via nebulization (3 mg BID) compared to placebo in subjects with non-cystic fibrosis bronchiectasis (NCFBE). Approximately 180 eligible subjects meeting all inclusion and no exclusion criteria will participate at approximately 45 sites in North America, the United Kingdom, and the European Union. Only subjects completing the Screening Period, meeting all inclusion, meeting no exclusion criteria, and meeting none of the randomization exclusion criteria will be randomized to receive blinded study medication: ensifentrine or placebo. The study has 3 periods: a Screening Period (up to 4 weeks, or 28 days), a Study Treatment Period (24 weeks or longer), and a Follow-up Period (4 to 10 days after your last dose of the study drug).

Institution
MUSC
Recruitment Contact
Isabella Brookshire
8437920965
recruitment@musc.edu



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