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

• Status: Active, not recruiting
• Trial end date: 2022-01-25
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to support the dose selection for future studies by evaluating efficacy and safety of different QBW251 doses in COPD patients with chronic bronchitis and a history of exacerbations, compared to placebo, when added to a triple combination therapy of LABA, LAMA and ICS with respect to trough FEV1 change from baseline after 12 weeks of treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Male and female COPD patients aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.

• Current or ex-smokers who have a smoking history of at least 10 pack years.

• Patients who have been treated with a triple combination of LABA/LAMA/ICS for the last 3 months prior to screening.

• Patients featuring chronic bronchitis

Exclusion Criteria:

• Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization, or a respiratory tract infection in the 4 weeks prior to screening, or between screening and randomization.

• Patients with any documented history of asthma, or with an onset of chronic respiratory symptoms, including a COPD diagnosis, prior to age 40 years.

• Patients with a body mass index (BMI) of more than 40 kg/m2.

• Use of other investigational drugs (approved or unapproved) within 30 days or 5 half-lives prior to screening, or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer; or longer if required by local regulations.

• Pregnant or nursing (lactating) women, and women of childbearing potential not willing to use acceptable effective methods of contraception during study participation.

• Other protocol-defined inclusion/exclusion criteria may apply