COMPLETED

A Study of Inhaled AZD8630 in Adolescents With Asthma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-06-11
Study Completion:2025-09-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT07065331

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.

Ages Eligible for Study:12 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Physician prescribed daily use of asthma medication.
  2. * Pre-bronchodilator Forced expiratory volume in one second (FEV1) ≥ 50% of the predicted normal value.
  3. * Asthma control questionnaire-5 (ACQ-5) \< 1.5 at Screening and Study Day 1.
  1. * History of any clinically important disease or disorder.
  2. * History of any chronic respiratory disorders (except asthma).
  3. * Acute exacerbation of asthma within 4 weeks of Screening.
  4. * Life -threatening asthma.
  5. * Completed treatment for respiratory infection with antibiotics within 4 weeks of Screening.
  6. * History of acquired or inherited immunodeficiency disorders.
  7. * Oral immunotherapy, including stable maintenance dose allergen-specific oral immunotherapy.

Contacts and Locations

Study Locations (Sites)

Research Site
Bakersfield, California, 93301
United States
Research Site
Miami Lakes, Florida, 33014
United States
Research Site
Lafayette, Louisiana, 70508
United States
Research Site
Raleigh, North Carolina, 27607
United States
Research Site
Toledo, Ohio, 43617
United States
Research Site
Oklahoma City, Oklahoma, 73120
United States
Research Site
Spartanburg, South Carolina, 29303
United States
Research Site
Boerne, Texas, 78006
United States
Research Site
Salt Lake City, Utah, 84107
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-11
Study Completion Date2025-09-19

Study Record Updates

Study Start Date2025-06-11
Study Completion Date2025-09-19

Terms related to this study

Keywords Provided by Researchers

  • Dry powder inhaler
  • Anti-Thymic stromal lymphopoietin

Additional Relevant MeSH Terms

  • Asthma