NCT02566044

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

A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Inhaled QBW276 in Patients With Cystic Fibrosis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Cystic Fibrosis

Interventions

Type	Name	Description
OTHER	Placebo	Placebo
DRUG	QBW276	0.3 mg and 1.5 mg strengths

Timeline

• Start date: 2017-09-27
• Primary completion: 2018-04-24
• Completion: 2018-04-24
• First posted: 2015-10-01
• Last updated: 2020-12-30
• Results posted: 2019-07-17

Locations

4 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study