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A Study of Inhaled AZD8630 in Adolescents With Asthma

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Asthma

Interventions: AZD8630, Dry powder inhaler

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 12 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key 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.

Key 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)

Bakersfield, California, United States
Miami Lakes, Florida, United States
Lafayette, Louisiana, United States
Raleigh, North Carolina, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Spartanburg, South Carolina, United States
Boerne, Texas, United States
Salt Lake City, Utah, United States