RecruitingChronic Obstructive Pulmonary Disease (COPD)

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

Eligible age

40–80 yrs

Accepts

All genders

Locations

27 states

Healthy volunteers

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About this study

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)

Sponsor: AstraZeneca

You may qualify if…

✓ 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 severe COPD exacerbations in the prior year; At least 1 of 2 moderate exacerbations must require the use of systemic corticosteroids. At least one of the previous exacerbations should be confirmed to have occurred while the participant was on triple or dual inhaled maintenance therapy
✓ 6. EOS ≥ 150 cells/μL during screening
✓ 7. CAT ≥15 at screening
✓ 8. Former or current smokers ≥10 pack-years

You may not qualify if…

✕ 1. Clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD
✕ 2. Asthma, incl. pediatric, or ACOS
✕ 3. Any unstable disorder that can impact participants safety or study outcomes
✕ 4. Tuberculosis requiring treatment within 12 months prior V2
✕ 5. Malignancies current or past
✕ Concomitant therapies:
✕ Macrolides (less than 6 months)
✕ Systemic immuno-suppressive, -modulating medications