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

  • STATUS
    Recruiting
  • End date
    Jan 25, 2022
  • participants needed
    956
  • sponsor
    Novartis Pharmaceuticals
Updated on 26 September 2021
Investigator
Novartis Pharmaceuticals
Primary Contact
Novartis Investigative Site (0.8 mi away) Contact
+173 other location
bronchitis

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.

Details
Condition Chronic Obstructive Lung Disease, COPD (Chronic Obstructive Pulmonary Disease)
Treatment Placebo, QBW251
Clinical Study IdentifierNCT04072887
SponsorNovartis Pharmaceuticals
Last Modified on26 September 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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