drugset / Trial / NCT02566044

Safety, Pharmacokinetics and Pharmacodynamics Study of Inhaled QBW276 in Patients With Cystic Fibrosis

NCT02566044 ↗

Phase 1/2 Completed 16 enrolled Novartis Pharmaceuticals
NaCrossoverDouble-blindTreatment

Summary

This is a study of multiple doses of inhaled QBW276 in patients with cystic fibrosis on top of standard of care. The study was divided into 3 Cohorts. Cohorts 1 and 2 are designed to be a randomized, double-blind, placebo-controlled, parallel arm, multiple dose study to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of inhaled QBW276 over 1 week (cohort 1) or 2 weeks (cohort 2) in patients with cystic fibrosis regardless of their genotype. The study was terminated after Cohort 2 due to the resource issues.

Timeline

Start
2017-09-27
Primary completion
2018-04-24
Completion
2018-04-24

Drugs

EvaluationDrugModalityDoseRoute
Subject QBW276 Unknown 0.3 mg Inhaled
Subject QBW276 Unknown 1.5 mg Inhaled
Subject QBW276 Unknown 3 mg Inhaled

Indications