Status:
COMPLETED
Tezepelumab COPD Exacerbation Study
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Amgen
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive...
Detailed Description
This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic ob...
Eligibility Criteria
Inclusion
- History of moderate to very severe physician-diagnosed COPD for at least 12 months prior to enrolment with a post-bronchodilator FEV1/FVC\<0.70 and a post-bronchodilator FEV1 ≥20% and ≤80% of predicted normal value.
- History of at least 2 documented moderate to severe COPD exacerbations within 2 to 52 weeks prior to enrollment.
- CAT score of ≥15 at enrollment and on day of randomization.
- Documented treatment with triple therapy for COPD (medium or high dose ICS/LABA/LAMA) throughout the year prior to enrollment. The dose of ICS should be stable for 3 months prior to enrollment.
Exclusion
- Clinically important pulmonary disease other than COPD, as judged by the Investigator (including current or historic asthma diagnosis).
- Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious (including risk factors for pneumonia), endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable.
- Major surgery within 8 weeks before enrollment.
- History of clinically significant infection requiring antibiotics or antiviral medication within 14 days before enrollment.
- Pregnant or breastfeeding.
- The chest/lungs with pathology that precludes the patient's ability to complete the study
- The patient has active COVID 19 infection during screening period.
Key Trial Info
Start Date :
July 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2024
Estimated Enrollment :
337 Patients enrolled
Trial Details
Trial ID
NCT04039113
Start Date
July 30 2019
End Date
January 31 2024
Last Update
February 18 2025
Active Locations (91)
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1
Research Site
Dothan, Alabama, United States, 36305
2
Research Site
Huntington Beach, California, United States, 92647
3
Research Site
Newport Beach, California, United States, 92663
4
Research Site
Upland, California, United States, 91786