Efficacy and Safety of Three Inhaled Dose Levels of AZD1402 Administered for Four Weeks in Adults With Asthma on Medium Dose Inhaled Corticosteroids

Summary

Participation Requirements

Description

Part 1 of the study will be randomised, double blind, placebo-controlled, and conducted in parallel for the 2 lower dose levels (Part 1a) followed by an unblinded safety review and escalation to the highest dose (Part 1b) dependent on the outcome of the safety review. Part 1a will consist of 30 part...

Part 1 of the study will be randomised, double blind, placebo-controlled, and conducted in parallel for the 2 lower dose levels (Part 1a) followed by an unblinded safety review and escalation to the highest dose (Part 1b) dependent on the outcome of the safety review. Part 1a will consist of 30 participants who will be randomised 1:1:1 to receive 1 of the 2 lower AZD1402 dry power inhaler (DPI) doses (Dose 1 or Dose 2) or placebo in parallel. Part 1b will consist of 15 participants who will be randomised 2:1 to receive the highest AZD1402 DPI dose (Dose 3) or placebo. Part 1a Lead-in Cohort AZD1402 Dose 1 AZD1402 Dose 2 Placebo Part 1b Lead-in Cohort AZD1402 Dose 3 Placebo Part 2 will be randomised, double blind, placebo controlled and will include 360 participants to evaluate 3 inhaled dose levels of AZD1402 versus placebo. Part 2a, which includes the 2 lower dose levels (Dose 1 and Dose 2) will be started in parallel after the unblinded safety review for Part 1a. The higher dose of Dose 3 (Part 2b) will be included in Part 2 following the unblinded review of Part 1b, depending on the outcome of the safety review. Once Part 2b starts, all 3 dose levels (and placebo) will run in parallel. Part 2 will include: AZD1402 Dose 1 AZD1402 Dose 2 AZD1402 Dose 3 Placebo

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