Phase 2a Study to Assess the Efficacy and Safety of AZD4604 in Adult Patients With Moderate-to-Severe Asthma Uncontrolled on Medium-High Dose ICS-LABA
NCT06020014 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 339
Last updated 2025-11-13
Summary
This is a Phase 2a, multicentre, randomised, placebo-controlled, double-blind, parallel-group study to evaluate the efficacy, safety and PK of AZD4604 administered BID using a dry-powder inhaler at one dose level over a 12-week Treatment period in adult participants with uncontrolled moderate-to-severe asthma.
Conditions
Interventions
- DRUG
-
AZD4604
AZD4604
- OTHER
-
Placebo
Placebo
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-16
- Primary Completion
- 2025-10-28
- Completion
- 2025-10-28
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Brazil
- Bulgaria
- Denmark
- France
- Germany
- India
- Malaysia
- Philippines
- South Africa
- South Korea
- Spain
- Sweden
- Taiwan
- Thailand
- United Kingdom
- Vietnam
Study Locations
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