BRONCHIECTASIS
ELIGIBILITY & REQUIREMENTS
- Completed the parent Phase II Trial (1397-0012).
WHAT'S INVOLVED
- The trial duration will be variable, part A will run for approximately 1 year, followed by open-label Part B for approximately 2 years.
- Monthly visits for the first 4 months, followed by a visit in 2 months then approximately every 12 weeks, with 12 weekly phone calls in between the visits.
- Located at our Nedlands clinic.
- A full health check by our doctors and nurses.
- Reimbursement for travel expenses.
STUDY OUTLINE
A randomized double-blind, roll-over Phase II trial evaluating the long-term safety, efficacy and tolerability of different oral doses of BI 1291583 in patients with bronchiectasis.
Part A of the study compares 3 different doses of BI 1291583. To keep the study blinded, you will receive a placebo as well. The placebo tablets in this study look like BI 1291583 tablets but contain no active drug.
If you were treated with BI 1291583 in your previous study the treatment will be continued with the same dose of BI 1291583.
If you were treated with placebo in your previous study, it will be decided by chance to assign you to one of the three doses of BI 1291583 in a 1:1:1 ratio.
This is called randomization. You will be getting one of the following treatments to take once daily:
- 1 mg of BI 1291583
- 2.5 mg of BI 1291583
- 5 mg of BI 1291583
Part B of the trial will be open label where all patients will receive 2.5mg of BI1291583.
To find out if this trial is suitable for you please register below, or contact our Clinical Trials Team at clinicaltrials@resphealth.uwa.edu.au or phone 6151 0888.
PRINCIPAL INVESTIGATOR
Dr Doug Forrester
THIS CLINICAL TRIAL IS CURRENTLY CLOSED
Please register your interest for future clinical trials and we will contact you when a suitable trial becomes available.