Tezepelumab COPD Exacerbation Study (COURSE)
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|ClinicalTrials.gov Identifier: NCT04039113|
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : January 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease (COPD)||Biological: Tezepelumab Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||282 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Subjects will be randomized in a 1:1 ratio to either tezepelumab or matching placebo both administered subcutaneously.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) (COURSE)|
|Actual Study Start Date :||July 30, 2019|
|Estimated Primary Completion Date :||February 14, 2022|
|Estimated Study Completion Date :||May 9, 2022|
Active Comparator: Tezepelumab
Tezepelumab, SC, Q4W
Tezepelumab subcutaneous injection
Placebo Comparator: Matching Placebo
Matching placebo, SC, Q4W
Placebo subcutaneous injection
- Moderate or severe COPD exacerbation rate ratio (tezepelumab vs placebo) [ Time Frame: Over 52 Weeks ]The exacerbation rate is based on exacerbations reported by the investigator over 52 weeks.
- Time to first moderate or severe COPD exacerbation [ Time Frame: By Week 52 ]Time to first occurrence of moderate/severe exacerbation post randomization. Outcome measures: Hazard ratio
- Proportion with at least one moderate/severe COPD exacerbation [ Time Frame: Over 52 Weeks ]Proportion of subjects with at least one moderate/severe exacerbation reported by the Investigator over 52 weeks Outcome measure: Odds Ratio
- Severe COPD exacerbation rate ratio (tezepelumab vs. placebo) [ Time Frame: Over 52 Weeks ]The severe exacerbation rate is based on severe exacerbations reported by the Investigator over 52 weeks.
- Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) [ Time Frame: Baseline, Week 52 ]
Difference in change from baseline in pre-BD forced expiratory volume in 1 second (FEV1) in tezepelumab arm as compared to placebo at Week 52.
FEV1 is defined as the volume of air exhaled from the lungs in the first second of forced expiration.
- Change in respiratory health status/health-related quality of life [ Time Frame: Baseline, Week 52 ]
Proportion of subjects achieving a decrease of 4 units or more in the St. George's Respiratory Questionnaire (SGRQ) total score at Week 52, i.e. minimum clinically important difference (MCID).
Outcome measure: odds ratio
- Change from baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score [ Time Frame: Baseline, Week 52 ]
Difference (tezepelumab vs. placebo) in SGRQ from baseline at Week 52.
SGRQ is a 50-item patient reported outcome questionnaire. The SGRQ total score is expressed as a percentage of overall impairment, in which 100% means the worst possible health status and 0% indicates the best possible health status. Likewise, the domain scores range from 0 to 100, with higher scores indicative of greater impairment. Decrease of 4 units is associated with a minimum clinically important difference (MCID).
- Change from baseline in the COPD Assessment Test (CAT) Total Score [ Time Frame: Baseline, Week 52 ]
Difference (tezepelumab vs. placebo) in COPD assessment tool (CAT) from baseline at Week 52.
CAT is an 8-item patient reported outcome questionnaire developed to measure the impact of COPD on health status. The instrument uses semantic differential six-point response scales. A CAT total score is the sum of item responses. The score ranges from 0 to 40, with higher scores indicating greater COPD impact on health status.
- Evaluate pharmacokinetics of tezepelumab [ Time Frame: Weeks 0, 4, 12, 24, 36, 52, 64 ]Serum trough concentration of tezepelumab
- Evaluate immunogenicity of tezepelumab [ Time Frame: Over 52 weeks ]Incidence of anti-drug antibodies (ADA)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039113
|Contact: AstraZeneca Clinical Study Information Centeremail@example.com|
|Principal Investigator:||Dave Singh, MD||Division of Infection, Immunity & Resp Medicine, The University of Manchester, United Kingdom|