Trials / Completed
CompletedNCT06020014
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
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 339 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | AZD4604 | AZD4604 |
| OTHER | Placebo | Placebo |
Timeline
- Start date
- 2023-11-16
- Primary completion
- 2025-10-28
- Completion
- 2025-10-28
- First posted
- 2023-08-31
- Last updated
- 2025-11-13
Locations
124 sites across 18 countries: United States, Argentina, Brazil, Bulgaria, Denmark, France, Germany, India, Malaysia, Philippines, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom, Vietnam
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06020014. Inclusion in this directory is not an endorsement.