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

Tezepelumab is being studied to see if it can reduce the number of moderate or severe COPD flare-ups and improve lung function in adults with moderate to very severe COPD. This research aims to evaluate its safety and effectiveness. The study is sponsored by AstraZeneca and includes participants who continue to have symptoms despite standard inhaled treatments.

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 should have had at least two moderate or one severe COPD exacerbations in the past year and be using inhaled COPD maintenance therapy. Both former and current smokers with a history of at least 10 pack-years are included. 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 and related expenses may vary and are not guaranteed to be covered. Participants should consider these factors when deciding to join the study.

Actively Recruiting

Phase 3

Age: 40Years - 80Years

All Genders

ID06883305

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

301

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. This Phase 3 study includes participants who have had at least two moderate or one severe COPD exacerbations in the past year despite inhaled maintenance therapy. The goal is to better understand if tezepelumab can reduce the rate of COPD exacerbations and improve lung function and quality of life. Participants will receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo for a treatment period lasting between 52 and 76 weeks. After the treatment phase, there is a 12-week off-treatment safety follow-up. The study is randomized, double-blind, and placebo-controlled, ensuring that neither participants nor researchers know who receives the active medication or placebo. During the study, participants will have regular assessments including lung function tests, questionnaires about respiratory health and symptoms, and blood samples to measure drug levels and immune response. Researchers will track COPD exacerbation frequency, lung function changes, and symptom improvements. Safety and tolerability will also be closely monitored throughout the treatment and follow-up periods, with total participation lasting up to approximately 88 weeks.

CONDITIONS

Brief Title

A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006)

Who Can Participate

Age: 40Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Age between 40 and 80 years
Diagnosed with COPD for at least 1 year
Post-bronchodilator FEV1 between 20% and 70% predicted, and FEV1/FVC ratio less than 0.70 at screening
On triple (ICS+LABA+LAMA) or dual inhaled COPD therapy for at least 3 consecutive months before the first visit
Had at least 2 moderate or 1 severe COPD exacerbations in the prior year; one moderate exacerbation must have required systemic corticosteroids
Blood eosinophil count of 150 cells/μL or higher at 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 other clinically important pulmonary diseases or radiological signs of respiratory diseases other than COPD
History of asthma, including pediatric asthma, or asthma-COPD overlap syndrome
Any unstable medical condition that could affect safety or study outcomes
Tuberculosis requiring treatment within 12 months prior to second visit
Current or past malignancies
Use of macrolide antibiotics within the last 6 months
Use of systemic immunosuppressive or immunomodulating medications
Long-term oxygen therapy exceeding 4.0 L/min or oxygen saturation below 89% despite oxygen therapy

Research Team

AstraZeneca Clinical Study Information Center

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