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Tezepelumab COPD Exacerbation Study
Tezepelumab COPD Exacerbation Study

NCT04039113

CompletedPhase 2

Sponsor: AstraZeneca

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Interventions: Tezepelumab, Placebo

Countries: United States, Canada, Denmark, France, Germany, Israel, Netherlands, South Korea

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)

Eligibility overview

Sex: ALL

Age: 40 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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:

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.
Locations (91)
  • Dothan, Alabama, United States
  • Huntington Beach, California, United States
  • Newport Beach, California, United States
  • Upland, California, United States
  • Westminster, California, United States
  • New Haven, Connecticut, United States
  • Brandon, Florida, United States
  • Orlando, Florida, United States
  • Panama City, Florida, United States
  • Tampa, Florida, United States
  • Winter Park, Florida, United States
  • Buckley, Michigan, United States
  • Albuquerque, New Mexico, United States
  • Charlotte, North Carolina, United States
  • Mooresville, North Carolina, United States
  • New Bern, North Carolina, United States
  • Columbus, Ohio, United States
  • Edmond, Oklahoma, United States
  • Medford, Oregon, United States
  • Philadelphia, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Mt. Pleasant, South Carolina, United States
  • Rock Hill, South Carolina, United States
  • Rapid City, South Dakota, United States
  • McKinney, Texas, United States
  • Abingdon, Virginia, United States
  • Everett, Washington, United States
  • Calgary, Alberta, Canada
  • Sherwood Park, Alberta, Canada
  • Vancouver, British Columbia, Canada
  • + 61 more on CT.gov