This Phase IIb dose-ranging study will evaluate the efficacy and safety of 3 different doses of AZD6793 compared with placebo tablets in participants with moderate to very severe chronic obstructive pulmonary disease.
A Multicentre, Parallel-group, Phase IIb, Randomised, Double-blind, Placebo-controlled, 4-Arm, 24-Week Study to Evaluate the Efficacy and Safety of AZD6793 Tablets in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PRESTO) Approximately 400 sites globally will participate in this study. Approximately 1160 participants will be randomized to four treatment groups; three different doses of AZD6793 vs placebo in a 1:1:1:1 ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,160
Annualised rate of moderate or severe COPD exacerbations
The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 24 Weeks treatment period compared to placebo
Time frame: From baseline up to 24 Weeks
Time to first moderate or severe COPD exacerbation
To evaluate the effect of AZD6793 as compared to placebo on COPD exacerbations from baseline up to 24 Weeks
Time frame: From baseline up to 24 Weeks
Annualised rate of COPD exacerbations associated with emergency room visits, urgent care visits, or hospitalisations
To evaluate the effect of AZD6793 as compared to placebo on COPD exacerbations from baseline up to 24 Weeks
Time frame: From baseline up to 24 Weeks
Annualised rate of severe COPD exacerbations
To evaluate the effect of AZD6793 as compared to placebo on COPD exacerbations from baseline up to 24 Weeks
Time frame: From baseline up to 24 Weeks
Annualised rate of COPDCompEx events
To evaluate the effect of AZD6793 as compared to placebo on COPDCompEx events from baseline up to 24 Weeks
Time frame: From baseline up to 24 Weeks
Time to first COPDCompEx event
To evaluate the effect of AZD6793 as compared to placebo on COPDCompEx events from baseline up to 24 Weeks
Time frame: From baseline up to 24 Weeks
Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)
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Research Site
Birmingham, Alabama, United States
RECRUITINGResearch Site
Glendale, Arizona, United States
NOT_YET_RECRUITINGResearch Site
Phoenix, Arizona, United States
RECRUITINGResearch Site
Phoenix, Arizona, United States
RECRUITINGResearch Site
Phoenix, Arizona, United States
RECRUITINGResearch Site
Canoga Park, California, United States
WITHDRAWNResearch Site
La Mesa, California, United States
WITHDRAWNResearch Site
Los Angeles, California, United States
RECRUITINGResearch Site
Newport Beach, California, United States
RECRUITINGResearch Site
Norco, California, United States
RECRUITING...and 353 more locations
Change from baseline in pre-BD FEV1 at Week 12 and Week 24 compared to placebo
Time frame: From baseline to Week 12 and Week 24
Change from baseline in post-bronchodilator (post-BD) forced expiratory volume in 1 second (FEV1)
Change from baseline in post-BD FEV1 at Week 12 and Week 24 compared to placebo
Time frame: From baseline to Week 12 and Week 24
Change from baseline in Breathlessness, Cough and Sputum Scale (BCSS) total score
Change from baseline in BCSS total score over 24 Weeks compared to placebo. The BCSS is a 3-item questionnaire rating breathlessness, sputum, and cough on a 5 point Likert scale from 0 (no symptoms) to 4 (severe symptoms). The BCSS has a scoring range of 0-12 with higher scores indicative of greater COPD impact on health status.
Time frame: From baseline over 24 Weeks
Change from baseline in COPD Assessment Test (CAT) total score
Change from baseline in the CAT total score over 24 weeks CAT is an 8-item PRO that measures the impact of COPD on the health status of patients with COPD. The CAT has a scoring range of 0-40 with higher scores indicative of greater COPD impact on health status.
Time frame: From baseline over 24 Weeks
Change from baseline in St George's Respiratory Questionnaire (SGRQ) total and domain scores
Participants achieving a clinically meaningful improvement from baseline in SGRQ total score (4-point score decrease) over 24 weeks. SGRQ is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with lower scores indicating better health status.
Time frame: From baseline over 24 Weeks
Measurement of plasma concentrations of AZD6793 at specific timepoints
To assess the pharmacokinetics (PK) of AZD6793 in participants with moderate to very severe COPD
Time frame: From baseline to Week 4, Week 12 and Week 24