CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
QBW276 +1 moredrug
Likely dose
QBW276 0.3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02566044
NCT02566044Phase 2Completed
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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

Novartis Pharmaceuticals·interventional·Posted Oct 1, 2015·Updated Dec 30, 2020

In Brief

A Phase 2 clinical trial evaluating Placebo and QBW276 for Pulmonary Cystic Fibrosis. Completed, enrolled 16 participants across 4 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Cystic Fibrosis
CountriesGermany, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 1, 2015
Enrollment StartSep 27, 2017
Primary CompletionApr 24, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.8 years ago

Interventions

Placeboother

Placebo

QBW276drug

0.3 mg and 1.5 mg strengths