For Healthcare Professionals

Tezepelumab COPD Exacerbation Study

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About the study

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)
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. 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.
  2. History of at least 2 documented moderate to severe COPD exacerbations within 2 to 52 weeks prior to enrollment.
  3. CAT score of ≥15 at enrollment and on day of randomization.
  4. 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.

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Clinically important pulmonary disease other than COPD, as judged by the Investigator (including current or historic asthma diagnosis).
  2. 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.
  3. Major surgery within 8 weeks before enrollment.
  4. History of clinically significant infection requiring antibiotics or antiviral medication within 14 days before enrollment.
  5. Pregnant or breastfeeding.
  6. The chest/lungs with pathology that precludes the patient's ability to complete the study
  7. The patient has active COVID 19 infection during screening period.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Chronic Obstructive Pulmonary Disease (COPD)

Age (in years)

40 - 80

Phase

Phase 2

Participants needed

337

Est. Completion Date

Jan 31, 2024

Treatment type

Interventional


Sponsor

AstraZeneca

ClinicalTrials.gov identifier

NCT04039113

Study number

D5241C00001

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