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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).

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520473-40-00
Acronym
D7860C00006
Enrollment
314
Registered
2025-09-22
Start date
2025-09-29
Completion date
Unknown
Last updated
2025-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Brief summary

Annualised rate of moderate or severe COPD exacerbations

Detailed description

Time to first moderate or severe COPD exacerbation: *Annualised rate of COPD exacerbations associated with emergency room visits, urgent care visits, or hospitalizations. *Annualised rate of severe COPD exacerbations. A severe exacerbation is defined as an exacerbation resulting in hospitalization or death due to COPD., * Annualised rate of COPDCompEx events. * Time to first COPDCompEx event., * Change from baseline in pre-bronchodilator (BD) FEV1 at Week 12 and Week 24. * Change from baseline in post-BD FEV1 at Week 12 and Week 24.", Change from baseline over 24 weeks in each of the following: - - Breathlessness, Cough and Sputum Scale (BCSS) total score. - COPD Assessment Test (CAT) total score - St George's Respiratory Questionnaire (SGRQ) total and domain scores., AZD6793 plasma concentrations at specific timepoints., Safety and tolerability evaluations as assessed by AEs, SAEs, AESis (X-ray confirmed pneumonia, serious infections, herpes zoster infections, severe COVID-19 infections, haematology events [anaemia, neutropenia, thrombocytopaenia], skin and hair depigmentation events during skin examinations) vital signs, physical examinations, clinical laboratory assessments (clinical chemistry, male reproductive hormones, haematology, and urinalysis), and ECGs

Interventions

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Annualised rate of moderate or severe COPD exacerbations

Secondary

MeasureTime frame
Time to first moderate or severe COPD exacerbation: *Annualised rate of COPD exacerbations associated with emergency room visits, urgent care visits, or hospitalizations. *Annualised rate of severe COPD exacerbations. A severe exacerbation is defined as an exacerbation resulting in hospitalization or death due to COPD., * Annualised rate of COPDCompEx events. * Time to first COPDCompEx event., * Change from baseline in pre-bronchodilator (BD) FEV1 at Week 12 and Week 24. * Change from baseline in post-BD FEV1 at Week 12 and Week 24.", Change from baseline over 24 weeks in each of the following: - - Breathlessness, Cough and Sputum Scale (BCSS) total score. - COPD Assessment Test (CAT) total score - St George's Respiratory Questionnaire (SGRQ) total and domain scores., AZD6793 plasma concentrations at specific timepoints., Safety and tolerability evaluations as assessed by AEs, SAEs, AESis (X-ray confirmed pneumonia, serious infections, herpes zoster in

Countries

Bulgaria, Denmark, Germany, Greece, Hungary, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026