A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subje… (NCT06016088) | Clinical Trial Compass
CompletedPhase 1/2
A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection
United States, Australia71 participantsStarted 2024-04-01
Plain-language summary
A double-blind, active-controlled, multiple-ascending dose, safety study of aerosolized RSP-1502 in subjects with cystic fibrosis Pseudomonas aeruginosa lung infection.
Who can participate
Age range
12 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.
Exclusion criteria
. The subject has not had a respiratory tract culture positive for these organisms within the 12 months before the date of informed consent.
. The subject has had at least 2 respiratory tract cultures negative for such organisms within the 12 months before the date of informed consent, with the first and last of these separated by at least 3 months, and the most recent one within the 6 months before the date of informed consent.
Questions worth asking your doctor
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.
1This trial tested an inhaled treatment called RSP-1502 specifically for Pseudomonas aeruginosa lung infections in cystic fibrosis — since that's exactly my situation, is there any published or preliminary data from this study that you've seen that might be relevant to my care?
2Since this was a Phase 1/2 study, it was still in early stages of figuring out safety and dosing — does that mean the safety profile of RSP-1502 isn't fully established yet, and how does that uncertainty compare to the antibiotic options I'm already on?
3The trial measured lung function changes through spirometry — do you know whether the results showed any meaningful improvement or decline in lung function, and how does that compare to what I might expect from my current treatment plan?
4The study tracked pulmonary exacerbations as an outcome — based on what you know about this trial, is there any signal about whether this inhaled approach might reduce my risk of exacerbations compared to what I'm doing now?
5Since recruitment for this trial is already completed, are there any follow-on studies or expanded access options for RSP-1502 that might be worth exploring, or is the evidence still too early to consider changing my current treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
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.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.