A Phase 2a Randomised, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of AZD4604 Twice Daily for Twelve Weeks in Adult Patients with Moderate to Severe Asthma Uncontrolled on Medium-High Dose ICS-LABA

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506000-50-00

Acronym

D8210C00003

Enrollment

124

Registered

2024-02-07

Start date

2024-09-26

Completion date

2025-06-12

Last updated

2025-06-04

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

Conditions

Adult Patients with Moderate-to-Severe Asthma Uncontrolled on Medium-High Dose ICS-LABA

Brief summary

Time to first CompEx (composite endpoint for exacerbation) event

Detailed description

Change from baseline in: 1 Pre-BD FEV1 at Week 4 and Week 12, CAAT at Week 4 and Week 12, ACQ-6 at Week 4 and Week 12, Average morning and average evening PEF at Week 4 and Week 12, and average over the 12-week Treatment period, Daily asthma symptom score (total, daytime, and night-time) at Week 4 and Week 12

Interventions

DRUGAZD4604

DRUGAZD4604 Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Time to first CompEx (composite endpoint for exacerbation) event	—

Secondary

Measure	Time frame
Change from baseline in: 1 Pre-BD FEV1 at Week 4 and Week 12, CAAT at Week 4 and Week 12, ACQ-6 at Week 4 and Week 12, Average morning and average evening PEF at Week 4 and Week 12, and average over the 12-week Treatment period, Daily asthma symptom score (total, daytime, and night-time) at Week 4 and Week 12	—

Countries

Bulgaria, Denmark, France, Germany, Netherlands, Spain, Sweden

Outcome results

None listed

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