Status:
COMPLETED
Dose-range Finding Efficacy and Safety Study for QBW251 in COPD Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief 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 w...
Detailed Description
This study used a 6 treatment arm, parallel-group, randomized, double-blind study design. 974 male and female COPD patients were randomized into the trial. The study consisted of four distinct study p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2022
Estimated Enrollment :
974 Patients enrolled
Trial Details
Trial ID
NCT04072887
Start Date
September 12 2019
End Date
February 1 2022
Last Update
April 28 2023
Active Locations (148)
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1
Novartis Investigative Site
Andalusia, Alabama, United States, 36420
2
Novartis Investigative Site
Los Angeles, California, United States, 90025
3
Novartis Investigative Site
Westminster, California, United States, 92683
4
Novartis Investigative Site
Ormond Beach, Florida, United States, 32174