Active — Not RecruitingPhase 1/2

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

Ukraine60 participantsStarted 2024-10-16

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Exclusion criteria

✕. creatinine \>1.5 times upper limit of normal (ULN)
✕. haemoglobin ≤8.0 g/dL
✕. platelets \<50x10\^9 cells/L
✕. serum potassium \<3.5 mmol/L
✕. aspartate aminotransferase (AST) \>3 x ULN
✕. alanine aminotransferase (ALT) \>3 x ULN
✕. alkaline phosphatase (ALP) ≥ 2.5 x ULN
✕. total bilirubin \>1.5 x ULN

What they're measuring

Incidence, intensity, causality, and seriousness of treatment-emergent adverse events (TEAEs).

Timeframe: 58 days

Changes in clinical laboratory values (haematology, clinical chemistry) at each time point.

Timeframe: 58 days

Changes in vital signs (blood pressure, heart rate, temperature, respiratory rate) and SpO2 at each time point.

Timeframe: 58 days

Trial details

NCT IDNCT06663176

SponsorThirty Respiratory Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-02-05

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