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

Completed · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID

NCT04072887

Run by

Novartis Pharmaceuticals

People needed

974

Starts

2019-09-12

Expected to finish

2022-02-01

Last updated by the study team

2023-04-28

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Westminster, California, United States
• Novartis Investigative Site — Ormond Beach, Florida, United States
• Novartis Investigative Site — Sarasota, Florida, United States
• Novartis Investigative Site — Winter Park, Florida, United States
• Novartis Investigative Site — Florence, Kentucky, United States
• Novartis Investigative Site — Crowley, Louisiana, United States
• Novartis Investigative Site — New Orleans, Louisiana, United States
• Novartis Investigative Site — Zachary, Louisiana, United States
• Novartis Investigative Site — Livonia, Michigan, United States
• Novartis Investigative Site — Edina, Minnesota, United States
• Novartis Investigative Site — Minneapolis, Minnesota, United States
• Novartis Investigative Site — Saint Charles, Missouri, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Omaha, Nebraska, United States
• Novartis Investigative Site — Charlotte, North Carolina, United States
• Novartis Investigative Site — Gastonia, North Carolina, United States
• Novartis Investigative Site — Shelby, North Carolina, United States
• Novartis Investigative Site — Columbus, Ohio, United States
• Novartis Investigative Site — Medford, Oregon, United States
• Novartis Investigative Site — El Paso, Texas, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — McKinney, Texas, United States
• Novartis Investigative Site — Midlothian, Virginia, United States
• Novartis Investigative Site — Andalusia, Alabama, United States

Full record on ClinicalTrials.gov

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