A Dose Range-Finding Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD8630 in Adults With Uncontrolled Asthma at Risk of Exacerbations
NCT06529419 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 537
Last updated 2026-03-02
Summary
A dose range-finding study to assess the efficacy and safety of multiple dose levels of AZD8630 administered via a dry powder inhaler in adults with uncontrolled asthma at risk of exacerbations, receiving medium -to -high dose inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA).
Conditions
Interventions
- DRUG
-
AZD8630
The drug will be administered by inhalation
- DRUG
-
The placebo will be administered by inhalation
- DEVICE
-
Inhaler
The drug/placebo will be administered by inhalation using the inhaler
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Njira Lugogo · Univeristy of Michigan Hospital, Ann Arbor, MI, US
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
- 2024-08-30
- Primary Completion
- 2026-02-04
- Completion
- 2026-02-04
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
- Argentina
- Belgium
- Chile
- China
- Czechia
- Denmark
- France
- Germany
- Hong Kong
- Israel
- Italy
- Japan
- Mexico
- Netherlands
- Slovakia
- South Africa
- South Korea
- Spain
- Taiwan
- Turkey (Türkiye)
- Ukraine
- United Kingdom
Study Locations
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