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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
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508706-23-00
Acronym
RESP30X-001
Enrollment
40
Registered
2024-04-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Cystic Fibrosis Bronchiectasis with Pseudomonas Aeruginosa or other Potentially Pathogenic Micro-organisms

Brief summary

1. Incidence, intensity, causality, and seriousness of treatment-emergent adverse events (TEAEs)., 2. Changes in clinical laboratory values (haematology, clinical chemistry) at each time point., 3. Changes in vital signs (blood pressure, heart rate, temperature, respiratory rate) and oxygen saturation (SpO2) at each time point.

Detailed description

Plasma PK parameters peak serum concentration (Cmax), time to peak serum concentration (Tmax), area under the concentration-time curve from dosing (time 0) to time t (AUC0-t), area under the concentration-time curve from dosing (time 0) to end of dosing period (AUC0-tau), area under the concentration-time curve for total drug exposure from dosing (time 0) extrapolated to infinity (AUC0-inf), trough plasma concentration (Ctrough), and half-life (t1/2).

Interventions

DRUGSALBUTAMOL

Sponsors

Thirty Respiratory Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. Incidence, intensity, causality, and seriousness of treatment-emergent adverse events (TEAEs)., 2. Changes in clinical laboratory values (haematology, clinical chemistry) at each time point., 3. Changes in vital signs (blood pressure, heart rate, temperature, respiratory rate) and oxygen saturation (SpO2) at each time point.

Secondary

MeasureTime frame
Plasma PK parameters peak serum concentration (Cmax), time to peak serum concentration (Tmax), area under the concentration-time curve from dosing (time 0) to time t (AUC0-t), area under the concentration-time curve from dosing (time 0) to end of dosing period (AUC0-tau), area under the concentration-time curve for total drug exposure from dosing (time 0) extrapolated to infinity (AUC0-inf), trough plasma concentration (Ctrough), and half-life (t1/2).

Countries

Bulgaria, Poland, Romania

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026