Tezepelumab COPD Exacerbation Study

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease (COPD)

In brief

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 Pulmonary Disease (COPD)

Key facts

Study ID

NCT04039113

Run by

AstraZeneca

People needed

337

Starts

2019-07-30

Expected to finish

2024-01-31

Last updated by the study team

2025-02-18

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Huntington Beach, California, United States
• Research Site — Newport Beach, California, United States
• Research Site — Upland, California, United States
• Research Site — Westminster, California, United States
• Research Site — New Haven, Connecticut, United States
• Research Site — Brandon, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Panama City, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Winter Park, Florida, United States
• Research Site — Buckley, Michigan, United States
• Research Site — Albuquerque, New Mexico, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Mooresville, North Carolina, United States
• Research Site — New Bern, North Carolina, United States
• Research Site — Columbus, Ohio, United States
• Research Site — Edmond, Oklahoma, United States
• Research Site — Medford, Oregon, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Pittsburgh, Pennsylvania, United States
• Research Site — Mt. Pleasant, South Carolina, United States
• Research Site — Rock Hill, South Carolina, United States
• Research Site — Rapid City, South Dakota, United States
• Research Site — McKinney, Texas, United States
• Research Site — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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