Tezepelumab COPD Exacerbation StudyCOURSE
Study Details
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)
Protocol Summary
Rate of Moderate or Severe COPD Exacerbations in Participants With Moderate to Very Severe COPD.
Timeframe: From randomisation up to Week 52
Time to First Moderate/Severe COPD Exacerbation
Timeframe: From randomisation up to Week 52
Proportion of Participants COPD Exacerbation Free at Week 52
Timeframe: From randomisation up to Week 52
Comparison of Annual Severe COPD Exacerbation Rates Over 52 Weeks
Timeframe: From randomisation up to Week 52
Proportion of Participants With >=1 Severe COPD Exacerbations Over 52 Weeks
Timeframe: From randomisation up to Week 52
Time to First Severe COPD Exacerbation
Timeframe: From randomisation up to Week 52
Least Square (LS) Mean Difference in Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 (FEV1) at Week 52
Timeframe: Baseline and Week 52
Lease Square (LS) Mean Difference in Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52
Timeframe: Baseline and Week 52
Proportion of Participants Achieving a Minimum Clinically Important Difference of 4 Units or More in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52
Timeframe: Baseline and Week 52
Least Square (LS) Mean Difference in Change From Baseline in COPD Assessment Tool (CAT) Total Score at Week 52
Timeframe: Baseline and Week 52
Serum Concentration of Tezepelumab
Timeframe: Pre-dose at weeks 0, 4, 12, 24, 36 and also at weeks 52 and 64 where no dosing was scheduled
Number of Participants With Anti-Drug Antibody (ADA) Response to Tezepelumab
Timeframe: Pre-dose at weeks 0, 4, 12, 24, 36 and also at weeks 52 and 64 where no dosing was scheduled