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

NCT04072887 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 974

Last updated 2023-04-28

Study results available
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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.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

QBW251

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

DRUG

Placebo

Placebo oral capsules administered twice a day for 24 weeks

DRUG

COPD maintenance background therapy

Combination of fluticasone furoate, vilanterol and umeclidinium bromide

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-12
Primary Completion
2021-10-08
Completion
2022-02-01
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • 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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04072887 on ClinicalTrials.gov