A Phase 2b, Multicenter, Randomized, Double-blind, Parallel group, Placebo-controlled, Dose Range Finding Study to Evaluate the Efficacy, Safety, and Tolerability of Nebulized CSL787 in Adults (18 to 85 years) with Non-cystic Fibrosis Bronchiectasis
Phase 2 – studying effectiveness and dosage
Conditions:
Non-cystic Fibrosis Bronchiectasis
Sponsor: CSL Behring LLC
trial.available_in:
БГ
Overview
Trial status: Authorised
Annualized Exacerbation Rate (AER) (Exacerbation Event Rate Per Participant-year of Follow-up), Number of Participants Achieving a Clinically Important Difference in the Quality of Life–Bronchiectasis (QoL-B) Respiratory Symptoms Scale, Percentage of Participants Achieving a Clinically Important Difference in the QoL-B Respiratory Symptoms Scale, Change From Baseline in QoL-B Respiratory Symptoms Scale, Change From Baseline in Total Colony-forming Unit (CFUs) for Pathogenic Bacteria isolated from Sputum, Number of Participants with Treatment-emergent Adverse events (TEAEs) and Serious Adverse Events (SAEs), Percentage of Participants with TEAEs and SAEs
TTF (Time to first) Exacerbation
Description
Annualized Exacerbation Rate (AER) (Exacerbation Event Rate Per Participant-year of Follow-up), Number of Participants Achieving a Clinically Important Difference in the Quality of Life–Bronchiectasis (QoL-B) Respiratory Symptoms Scale, Percentage of Participants Achieving a Clinically Important Difference in the QoL-B Respiratory Symptoms Scale, Change From Baseline in QoL-B Respiratory Symptoms Scale, Change From Baseline in Total Colony-forming Unit (CFUs) for Pathogenic Bacteria isolated from Sputum, Number of Participants with Treatment-emergent Adverse events (TEAEs) and Serious Adverse Events (SAEs), Percentage of Participants with TEAEs and SAEs
Who can participate
Age group: 18-64 years, 65+ years
Gender: Female, Male
Target enrollment: 226 participants