What is tezepelumab studying for chronic obstructive pulmonary disease (COPD)?

Tezepelumab is being studied to evaluate its safety and effectiveness in adults with moderate to very severe COPD who continue to experience exacerbations despite inhaled maintenance therapy. The trial aims to understand if tezepelumab can reduce the frequency of COPD flare-ups and improve lung function and symptoms. AstraZeneca is leading this research to explore new treatment options for COPD.

Who may be eligible for this COPD clinical trial?

Adults aged 40 to 80 years with a diagnosis of COPD for at least one year may be eligible. Participants must have experienced at least two moderate or one severe COPD exacerbations in the past year and be receiving inhaled maintenance therapy. Both former and current smokers with an eosinophil count of at least 150 cells/µL can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this COPD clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other related costs may vary and are not guaranteed to be covered. Participants should plan accordingly for any expenses outside of the study care.

Actively Recruiting

Phase 3

Age: 40Years - 80Years

All Genders

ID06878261

A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Led by AstraZeneca · Updated on 2026-05-07

990

Participants Needed

268

Research Sites

12 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease COPD. Participants must have a COPD diagnosis of at least one year, be receiving inhaled maintenance therapy, and have experienced at least two moderate or one severe COPD exacerbations in the past year. This phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to better understand tezepelumabs impact on COPD symptoms and exacerbations. Participants will be randomly assigned to receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. The treatment phase will last for a minimum of 52 weeks and up to 76 weeks. After completing the treatment period, there will be a 12-week off-treatment safety follow-up to monitor participants health. Throughout the study, participants will undergo regular assessments including lung function tests, questionnaires such as the St. Georges Respiratory Questionnaire SGRQ and COPD Assessment Test CAT, and blood tests to measure eosinophil counts and drug levels. Researchers will track the annualized rate of moderate or severe COPD exacerbations as the primary outcome. Other evaluations include monitoring exacerbations requiring emergency visits or hospitalization, lung function changes, symptom scores, and immune responses. Participant safety and adherence to the study protocol will be closely monitored during and after treatment.

CONDITIONS

Brief Title

A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)

Who Can Participate

Age: 40Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Age between 40 and 80 years
Diagnosis of COPD for at least 1 year
Post-bronchodilator FEV1 between 20% and 70% predicted and FEV1/FVC less than 0.70 at screening
Receiving triple inhaled COPD therapy (ICS+LABA+LAMA) or dual inhaled therapy for at least 3 consecutive months prior to Visit 1
At least 2 moderate or 1 severe COPD exacerbations in the prior year, with at least 1 moderate exacerbation requiring systemic corticosteroids
Blood eosinophil count of at least 150 cells/µL during screening
COPD Assessment Test (CAT) score of 15 or higher at screening
Former or current smokers with at least 10 pack-years smoking history

You will not qualify if you...

Presence of clinically important pulmonary disease or lung imaging findings other than COPD
History of asthma, including pediatric asthma, or asthma-COPD overlap syndrome (ACOS)
Any unstable disorder that may affect participant safety or study results
Tuberculosis requiring treatment within 12 months prior to Visit 2
Current or past malignancies
Use of macrolide antibiotics within less than 6 months
Use of systemic immunosuppressive or immunomodulating medications
Long-term oxygen therapy (LTOT) greater than 4.0 L/min or oxygen saturation below 89% despite LTOT

Research Team

AstraZeneca Clinical Study Information Center

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