NCT04072887|CompletedPhase 2ResultsDMCFDA Drug

Dose-range Finding Efficacy and Safety Study for QBW251 in COPD Patients

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 ClinicalTrials.gov

Compare

2 other identifiers

CQBW251B22012018-003197-28

Study Type

interventional

Target

974

Locations

25 countries

Sites

144

Timeline

RegisteredAug 2019

StartedSep 2019

CompletionFeb 2022

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

974

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Sep 2019

Geographic Reach

25 countries

144 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.4 years study duration

First Submitted

Initial submission to the registry

August 7, 2019

Completed

21 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed

15 days until next milestone

Study Start

First participant enrolled

September 12, 2019

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2021

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

April 28, 2023

Completed

Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

2.1 years

First QC Date

August 7, 2019

Results QC Date

January 30, 2023

Last Update Submit

April 6, 2023

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12
The primary efficacy analysis assessed the effect of QBW251 on the absolute change from baseline in trough FEV1 in liters on Week 12. Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline measurement was defined as the baseline visit pre-bronchodilator spirometry assessment. Change from baseline in the FEV1 mean scores were analyzed using a Mixed Model for Repeated Measures (MMRM): treatment + baseline score + smoking status at screening + run-in FEV1 + airflow limitation severity + region + time interval + treatment\*time interval interaction + baseline score\*time interval interaction.
Baseline and Week 12

Secondary Outcomes (10)

Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Baseline, weeks 4, 8, 16, 20 and 24
Change From Baseline in Evaluating Respiratory Symptoms (E-RS); Total Score
Baseline, weeks 12 and 24
Change From Baseline in Evaluating Respiratory Symptoms (E-RS); Cough and Sputum Score
Baseline, weeks 12 and 24
Number of Participants With a "Better" Change in the Patient Global Impression of Severity (PGI-S) From Baseline
Baseline, weeks 12 and 24
Change From Baseline in the Cough and Sputum Assessment Questionnaire (CASA-Q)
Baseline, weeks 12 and 24
+5 more secondary outcomes