CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 974 enrolled
Drug / intervention
QBW251 +2 moredrug
Likely dose
QBW251 25 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/NCT04072887
NCT04072887Phase 2Completed
CompareCT.gov

A 24-week Multi-center, Double-blind, Placebo Controlled Dose-range Finding Study to Investigate the Efficacy and Safety of Oral QBW251 in COPD Patients on Triple Inhaled Therapy (LABA / LAMA / ICS)

Novartis Pharmaceuticals·interventional·Posted Aug 28, 2019·Updated Apr 28, 2023

In Brief

A Phase 2 clinical trial evaluating QBW251, Placebo, and 1 other intervention for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 974 participants across 148 sites in 26 countries.

Detailed Summary

This clinical study was designed to support the dose selection for future studies by evaluating efficacy and safety of different QBW251 doses in Chronic obstructive pulmonary disease (COPD) patients with chronic bronchitis and a history of exacerbations, compared to placebo, when added to a triple inhaled therapy of LABA, LAMA and ICS.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesArgentina, Australia, Austria, Belgium, Canada, Colombia, Czechia, Denmark, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Italy, Japan, Netherlands, Philippines, Poland, Slovakia, South Korea, Spain, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedAug 28, 2019
Enrollment StartSep 12, 2019
Primary CompletionOct 8, 2021
Study CompletionFeb 1, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.8 years ago

Interventions

QBW251drug

QBW251 oral capsules (450, 300, 150, 75 and 25 mg) of identical appearance to ensure blinding administered twice a day (b.i.d) for 24 weeks

Placebodrug

Placebo oral capsules administered twice a day for 24 weeks

COPD maintenance background therapydrug

Combination of fluticasone furoate, vilanterol and umeclidinium bromide