Status:
COMPLETED
Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-90 years
Phase:
PHASE2
Brief Summary
This is a Phase 2 study in patients with chronic obstructive pulmonary disease (COPD) to assess the efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and safety of two dose levels of CSJ117 in c...
Detailed Description
This is a randomized, participant- and investigator-blinded, placebo-controlled, parallel group, multicenter study with two fixed-dose levels of CSJ117 (4 mg, 8 mg) administered once-daily via oral in...
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 with a documented diagnosis of COPD for at least 1 year prior to screening visit
Exclusion
- Patients with a past or current medical history of asthma
- 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 hospitalization between screening and prior to treatment.
- 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
- Patients with a body mass index (BMI) of more than 40 kg/m2 Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
September 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2022
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04882124
Start Date
September 24 2021
End Date
September 15 2022
Last Update
November 28 2022
Active Locations (15)
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1
Novartis Investigative Site
Andalusia, Alabama, United States, 36420
2
Novartis Investigative Site
Crowley, Louisiana, United States, 70526
3
Novartis Investigative Site
New Orleans, Louisiana, United States, 70115
4
Novartis Investigative Site
Saint Charles, Missouri, United States, 63301