Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS)

Sex: All

Ages: 12 Years – 80 Years

Healthy volunteers: No

Phase: PHASE3

Enrollment: 2187

Sponsor: AstraZeneca

Summary

This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care.

Eligibility Criteria

Inclusion Criteria: 1. 12 to 80 years of age, male and female, BMI \ and/or = 1 year prior to V1. 3. Regularly using a stable daily ICS/LABA regimen (including a stable ICS dose) with medium-to-high ICS doses for at least 4 weeks prior to V1. 4. ACQ-7 total score ≥1.5 at Visits 1, 3, and 5 (pre-randomization). 5. FEV1 % (assessed as an average of the 60 and 30 minute pre-dose assessments) predicted normal at V1, 2, 3, 4, and 5 (pre-randomization) * Participants \> and/or = 18 years of age: \< 80% * Participants 12 to \ and/or = 18 years of age: Increase \> and/or = 12% and \> and/or = 200 mL. * Participants 12 to \10 pack-years history, or former smokers who stopped smoking \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04609904). StuddyBuddy aggregates publicly available trial information.