RECRUITING

A Study of Inhaled AZD8630 in Adolescents With Asthma

Description

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.

Conditions

Asthma
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Related Conditions:

Asthma

Study Overview

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Study Details

Study overview

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.

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

A Study of Inhaled AZD8630 in Adolescents With Asthma

Condition
Asthma
Intervention / Treatment

-

Contacts and Locations

Bakersfield

Research Site, Bakersfield, California, United States, 93301

Miami Lakes

Research Site, Miami Lakes, Florida, United States, 33014

Lafayette

Research Site, Lafayette, Louisiana, United States, 70508

Omaha

Research Site, Omaha, Nebraska, United States, 68134

Raleigh

Research Site, Raleigh, North Carolina, United States, 27607

Toledo

Research Site, Toledo, Ohio, United States, 43617

Oklahoma City

Research Site, Oklahoma City, Oklahoma, United States, 73120

Medford

Research Site, Medford, Oregon, United States, 97504

Spartanburg

Research Site, Spartanburg, South Carolina, United States, 29303

Austin

Research Site, Austin, Texas, United States, 78759

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

12 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2026-02-25