Condition

Patients with Bronchiectasis

Purpose of the study

This clinical trial is designed to evaluate the efficacy, safety and tolerability of BI1291583 (2.5mg) compared to placebo in participants with bronchiectasis. NCT06872892

Official Title

A Phase III, randomized, 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). NCFBE + CFBE patients will be enrolled to this trial.

Who is eligible to participate?

Inclusion Criteria

• Clinical history consistent with bronchiectasis and investigator confirmed diagnosis of bronchiectasis by computed tomography (CT) scan
• History of pulmonary exacerbations requiring antibiotic treatment in the last 12 months before Visit 1, participants must have had either:
  • at least 2 pulmonary exacerbations, or
  • at least 1 exacerbation and an SGRQ Symptoms score of >40 at screening Visit 1

Exclusion criteria:

• Tuberculosis or non-tuberculosis mycobacterial infection being treated or requiring treatment
• Previous treatment with a dipeptidyl peptidase-1 (DPP1) (Cathepsin C (CatC)) inhibitor. (Note: Participants that were randomised and only received placebo in studies with DPP1 (CatC) inhibitor are allowed.) Further exclusion criteria apply
• Any clinically relevant (at the discretion of the investigator) acute respiratory infection or ongoing pulmonary exacerbation at screening visit or during the screening unless recovered in the opinion of the investigator prior to Visit 2.

Register your interest

To register your interest or find out more information about this clinical trial, please email: enquiries@gallipoliresearch.org.au. 

Study location

Gallipoli Medical Research, Greenslopes Private Hospital, Brisbane