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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224866

Enrollment

900

Registered

2019-09-12

Start date

2019-09-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Interventions

investigational material(s) Generic name etc : QBW251 INN of investigational material : - Therapeutic category code : 229 Other agents affecting respiratory organs Dosage and Administration for Invest

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male and female adults aged >=40 years at screening. - Patients who have been treated with a combination of LABA/LAMA or LABA/ICS or LABA/LAMA/ICS at a stable dose for the last 3 months prior to screening. - Current or ex-smokers who have a smoking history of at least 10 pack years at screening.

Exclusion criteria

Exclusion criteria: - Patients with a history of long-QT syndrome or whose QTcF interval at screening - Patients who have a clinically significant* ECG abnormality before randomization. - Clinical laboratory values abnormalities considered as clinically significant in the opinion of the Investigator at screening. Patients who have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, or hematological abnormalities, which could interfere with the assessment of the efficacy and safety of the study treatment, or patients with uncontrolled Type II diabetes. - Patients who develop a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization during screening. - Patients who have had a respiratory tract infection within 4 weeks prior to screening. If a respiratory tract infection occurs during screening. - Patients with history of asthma or any other clinically relevant lung diseases.. - Patients with pulmonary lobectomy, lung volume reduction surgery, bronchoscopic lung volume reductions, or lung transplantation. - Patients with a body mass index (BMI) of more than 40 kg/m2. - Pregnant or nursing (lactating) women, where pregnancy was defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.

Design outcomes

Primary

Measure	Time frame
Efficacy Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12	—

Countries

Asia except Japan, Europe, Japan, North America

Contacts

Public ContactTakamitsu Hirano

Novartis Pharma. K.K.

rinshoshiken.toroku@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026