River Forest, Illinois 60305

  • Pulmonary Disease, Chronic Obstructive

Purpose:

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.


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


NCT ID:

NCT04072887


Primary Contact:

Novartis Pharmaceuticals
Phone: 1-888-669-6682
Email: novartis.email@novartis.com


Backup Contact:

Novartis Pharmaceuticals
Phone: +41613241111


Location Contact:

River Forest, Illinois 60305
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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