Tezepelumab for Chronic Obstructive Pulmonary Disease (COPD)

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

Recruiting Phase 3 Interventional Study
Chronic Obstructive Pulmonary Disease (COPD)
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
40 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
990 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for

This trial is looking for adults with moderate to very severe COPD. Participants will be required to take part in assessments and treatments involving Tezepelumab.

Are You a Good Fit for This Trial?
Must be taking Inhaled COPD therapy
Must not be taking Macrolides
Rules you out TuberculosisCancer

You may be able to join if

  • I am between 40 and 80 years old.
  • I have been diagnosed with COPD for at least 1 year.
  • I have moderate to severe COPD symptoms.
  • I have had at least 2 moderate or 1 severe COPD flare-ups in the past year.
  • I have been using COPD inhaler treatments for at least 3 months.
  • I have a certain level of eosinophils in my blood.
  • I have a CAT score of 15 or higher.
  • I am a former or current smoker with at least 10 pack-years.

You may not be able to join if

  • I have another significant lung disease.
  • I have asthma or a related condition.
  • I have an unstable health condition that affects my safety.
  • I was treated for tuberculosis in the last 12 months.
  • I have had cancer in the past or currently have it.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. ≥40 to ≤80 years old 2. COPD diagnosis ≥1 year, 3. Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC \<0.70 at screening 4. Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy, if triple therapy is considered not appropriate, ≥3 consecutive months prior to V1 5. ≥2 moderate or ≥1 sev…
Contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

CONTACT