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A Study of Inhaled AZD8630 in Adolescents With Asthma | Clinical Trials | Clareo Health

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A Study of Inhaled AZD8630 in Adolescents With Asthma

A Phase I, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Inhaled AZD8630 in Adolescents With Asthma

NCT07065331•AstraZeneca

Summary

The purpose of this study is to evaluate the pharmacokinetic (PK) profile, safety, tolerability, and immunogenicity of single inhaled dose of AZD8630 administered in adolescent participants with asthma as well as the safety and performance of the dry powder inhaler.

Detailed Description

This is a Phase 1, open label, single dose study that will be conducted in adolescent participants with asthma where the participants will receive AZD8630 administered via dry powder inhaler. The study will be comprised of: * A screening period. * A treatment period. * A post treatment period. * A final Follow-up visit.

Eligibility

Age

12 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Physician prescribed daily use of asthma medication.
•Pre-bronchodilator Forced expiratory volume in one second (FEV1) ≥ 50% of the predicted normal value.
•Asthma control questionnaire-5 (ACQ-5) \< 1.5 at Screening and Study Day 1.

Exclusion Criteria

•History of any clinically important disease or disorder.
•History of any chronic respiratory disorders (except asthma).
•Acute exacerbation of asthma within 4 weeks of Screening.
•Life -threatening asthma.
•Completed treatment for respiratory infection with antibiotics within 4 weeks of Screening.
•History of acquired or inherited immunodeficiency disorders.
•Oral immunotherapy, including stable maintenance dose allergen-specific oral immunotherapy.

Locations (9)

Research Site

Bakersfield, California, United States

Research Site

Miami Lakes, Florida, United States

Research Site

Lafayette, Louisiana, United States

Research Site

Raleigh, North Carolina, United States

Research Site

Toledo, Ohio, United States

Research Site

Oklahoma City, Oklahoma, United States

Research Site

Spartanburg, South Carolina, United States

Research Site

Boerne, Texas, United States

Research Site

Salt Lake City, Utah, United States

Key Dates

Start Date

June 11, 2025

Primary Completion Date

September 19, 2025

Completion Date

September 19, 2025

Last Updated

October 14, 2025

Enrollment

ACTUAL participants

Conditions

Asthma

Interventions

AZD8630

DRUG

Dry powder inhaler

DEVICE

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

View study

RECRUITING

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Inhaled AZD8630 in Adolescents With Asthma

Inclusion Criteria

Exclusion Criteria

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

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