Study of a Nebulised Nitric Oxide Generating Solution in Patients With Mycobacterium Abscessus
NCT05101915 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2024-05-10
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
Conditions
Interventions
- DRUG
-
RESP301
Inhaled IMP delivered via nebulisation
Sponsors & Collaborators
-
Papworth Hospital NHS Foundation Trust
lead OTHER_GOV
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-01
- Primary Completion
- 2024-01-31
- Completion
- 2024-04-23
Countries
- United Kingdom
Study Locations
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