NCT06663176

Nebulised RESP30X Nitric Oxide Formulations in NCFB Patients With Pseudomonas Aeruginosa (Pa)

Phase 1/2a Trial to Evaluate the Safety, Tolerability and Efficacy of Nebulised RESP30X Nitric Oxide Formulations in Non-Cystic Fibrosis Bronchiectasis (NCFB) Patients With Pseudomonas Aeruginosa (Pa) or Other Potentially Pathogenic Micro-organisms (PPMs)

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Thirty Respiratory Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1/2a, Multi-Centre, Randomised, Open-label study to assess the safety, tolerability, PK, and efficacy of RESP30X in Adult NCFB participants with confirmed high-titre respiratory PPMs.

Detailed description

A total of approximately 60 participants will be enrolled in this study, to give 30 participants completing the study. Part 1: Approximately 12 NCFB patients with confirmed high-titre Pa (≥10\^5 CFU/mL) to be enrolled to give 6 participants completing the study. Participants will receive treatment with nebulised RESP303 in a Single Ascending Dose (SAD) phase followed by RESP303 three times a day (TID) multiple daily dosing for 28-days. A safety review committee will meet after 6 participants have completed the study to determine whether Part 2 of the study can be initiated. Part 2: Approximately 48 NCFB patients with confirmed high-titre respiratory PPMs (≥10\^5 CFU/mL) to be enrolled to give 24 participants completing the study. Participants will be randomised to receive treatment with nebulised RESP302 in a SAD phase, followed by RESP302 TID multiple daily dosing for 28-days, or nebulised RESP303 in a SAD phase, followed by either RESP303 twice a day (BID) or RESP303 TID multiple daily dosing for 28-days (1:1:1).

Conditions

• Non-Cystic Fibrosis Bronchiectasis

Interventions

Type	Name	Description
DRUG	RESP302	Nitric Oxide agent
DRUG	RESP303	Nitric Oxide agent

Timeline

• Start date: 2024-10-16
• Primary completion: 2028-02-05
• Completion: 2028-05-05
• First posted: 2024-10-29
• Last updated: 2026-03-10

Locations

1 site across 1 country: Ukraine