Tezepelumab COPD Exacerbation Study

  • STATUS
    Recruiting
  • End date
    May 22, 2023
  • participants needed
    338
  • sponsor
    AstraZeneca
Updated on 15 October 2021
ct scan
bronchodilator
severe chronic obstructive pulmonary disease
copd exacerbation

Summary

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)

Description

This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving triple inhaled maintenance therapy, and having had 2 or more documented COPD exacerbations in the 12 months prior to Visit 1. Approximately, 282 subjects will be randomized globally. Subjects will be stratified by region and prior number of exacerbations (2 vs. 3 or more). Subjects will receive tezepelumab, or placebo, administered via subcutaneous injection at the study site, over a 52 week treatment period. The study also includes a post-treatment follow-up period of 12 weeks.

Details
Condition Chronic Obstructive Lung Disease, COPD (Chronic Obstructive Pulmonary Disease), chronic obstructive pulmonary disease, COPD, chronic obstructive pulmonary disease (copd)
Treatment Placebo, Tezepelumab
Clinical Study IdentifierNCT04039113
SponsorAstraZeneca
Last Modified on15 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Clinically important pulmonary disease other than COPD, as judged by the Investigator (including current or historic asthma diagnosis)
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
Major surgery within 8 weeks before enrollment
History of clinically significant infection requiring antibiotics or antiviral medication within 14 days before enrollment
Pregnant or breastfeeding
The chest/lungs with pathology that precludes the patient's ability to complete the study
The patient has active COVID 19 infection during screening period
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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