Study of a Nebulised Nitric Oxide Generating Solution in Patients With Mycobacterium Abscessus (NCT05101915) | Clinical Trial Compass
TerminatedPhase 2
Study of a Nebulised Nitric Oxide Generating Solution in Patients With Mycobacterium Abscessus
Stopped: TSC recommended early termination due to lack of futility of the trial.
United Kingdom6 participantsStarted 2021-11-01
Plain-language summary
* To evaluate the change in M. abscessus cfu/g in induced sputum samples from baseline to the end of treatment with RESP301 in patients with cystic fibrosis who have treatment-naïve or treatment-refractory M. abscessus-pulmonary disease
* To assess the safety and tolerability of RESP301 during treatment (28 days) and follow up (84 days) in patients with cystic fibrosis who have treatment naïve or treatment refractory M. abscessus-pulmonary disease
Who can participate
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.
Inclusion criteria
. Adult patients of ≥18 years at time of informed consent
. Patients with a clinical diagnosis of CF and confirmed by genetic testing
. Diagnosis of treatment naïve or treatment refractory M. abscessus-PD
. Signed informed consent documentation (indicating an understanding of the purpose and a willingness to meet the requirements for participation in the study)
Exclusion criteria
. FEV1 \<40% predicted
. Methaemoglobin concentration \> 2%
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Mycobacterial load in induced sputum samples
Timeframe: Through study completion, average one year
2
Safety and tolerability
Timeframe: Through study completion, average one year