This is a study to determine the safety and tolerability of 28 days of daily dosing of two doses (280 mg and 560 mg) of Arikayce™ versus placebo in patients who have bronchiectasis and chronic infection due to Pseudomonas infection.
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Timeframe: Day 1 through 56.
Treatment-emergent Marked Laboratory Abnormalities up to 28 Days After Study Medication Discontinuation
Timeframe: Day 1 through 56.
Treatment-emergent Pulmonary Function Test (PFT) for Acute Tolerability Assessment
Timeframe: Pre-dose, 0-1 hour post-dose and 2-4 hours post-dose on day 1, 0-1 hour post-dose and 2-4 hours post-dose on day 14, and 0-1 hour post-dose and 2-4 hours post-dose on day 28
Treatment-emergent PFT Abnormalities up to the End of Study
Timeframe: Day 1, Day 14 and Day 28
Number of Subjects With an Adverse Event Leading to Permanent Discontinuation of Study Medication
Timeframe: Screening to Day 56
Serious Adverse Events up to 28 Days After Study Medication Discontinuation
Timeframe: Screening to Day 56