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 range18 Years
SexALL
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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%
✕. Use of nitric oxide donor medications such as prilocaine, sodium nitroprusside, and nitroglycerine within 30 days of proposed first treatment
✕. Use of phosphodiesterase inhibitors (e.g., sildenafil) within 30 days of proposed first treatment
✕. Evidence of pulmonary hypertension
✕
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