A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Different Devices in Participants Aged 4 to Less Than 12 Years Old With Asthma

NCT07433569 | Active Not Recruiting Phase 1 FDA Drug FDA Device

• 2 other identifiers: D7820C000055570196
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to assess the pharmacokinetics (PK) and safety of symbicort aerosphere and symbicort pressurized metered dose inhaler (pMDI) in participants with asthma aged 4 to less than 12 years.

Conditions

Asthma

Keywords

Pediatric; Pharmacokinetics; Budesonide; Formoterol; Symbicort Aerosphere; Symbicort pressurized metered dose inhaler (pMDI)

Outcome Measures

Primary Outcomes (2)

• Maximum observed plasma concentration (Cmax)

  To determine and compare the systemic availability (Cmax) of budesonide and formoterol after single doses of Symbicort Aerosphere and Symbicort pMDI in participants 4 to less than 12 years of age with asthma.

  Participants < 30 kg: Predose, 5 minutes, 10 minutes, 30 minutes, 3 hours, and 6 hours postdose; Participants ≥ 30 kg: Predose, 5 minutes, 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, and 8 hours postdose

• Area under the plasma concentration-time curve from time 0 to 6 hours postdose (AUC0-6)

  To determine and compare the systemic availability (AUC0-6) of budesonide and formoterol after single doses of Symbicort Aerosphere and Symbicort pMDI in participants 4 to less than 12 years of age with asthma.

  Participants < 30 kg: Predose, 5 minutes, 10 minutes, 30 minutes, 3 hours, and 6 hours postdose; Participants ≥ 30 kg: Predose, 5 minutes, 10 minutes, 30 minutes, 1 hour, 3 hours and 6 hours postdose

Secondary Outcomes (9)

• Time to reach peak or maximum observed concentration or response following drug administration (tmax)

  Participants < 30 kg: Predose, 5 minutes, 10 minutes, 30 minutes, 3 hours, and 6 hours postdose; Participants ≥ 30 kg: Predose, 5 minutes, 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, and 8 hours postdose

• Terminal elimination rate constant (λz)

  Participants < 30 kg: Predose, 5 minutes, 10 minutes, 30 minutes, 3 hours, and 6 hours postdose; Participants ≥ 30 kg: Predose, 5 minutes, 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, and 8 hours postdose

• Terminal elimination half-life (t½λz)

  Participants < 30 kg: Predose, 5 minutes, 10 minutes, 30 minutes, 3 hours, and 6 hours postdose; Participants ≥ 30 kg: Predose, 5 minutes, 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, and 8 hours postdose

• Area under plasma concentration-time curve from time 0 to infinity (AUCinf)

  Participants < 30 kg: Predose, 5 minutes, 10 minutes, 30 minutes, 3 hours, and 6 hours postdose; Participants ≥ 30 kg: Predose, 5 minutes, 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, and 8 hours postdose

• Mean residence time (MRT)

  Participants < 30 kg: Predose, 5 minutes, 10 minutes, 30 minutes, 3 hours, and 6 hours postdose; Participants ≥ 30 kg: Predose, 5 minutes, 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, and 8 hours postdose

Study Arms (2)

Sequence AB

EXPERIMENTAL

In study period 1, participants will receive a single dose of treatment A (test formulation) and in study period 2, participants will receive a single dose of treatment B (reference formulation).

Combination Product: Budesonide/formoterol fumarate Aerosphere; Combination Product: Budesonide/formoterol fumarate pMDI

Sequence BA

EXPERIMENTAL

In study period 1, participants will receive a single dose of treatment B (reference formulation) and in study period 2, participants will receive a single dose of treatment A (test formulation).

Combination Product: Budesonide/formoterol fumarate Aerosphere; Combination Product: Budesonide/formoterol fumarate pMDI

Interventions

Budesonide/formoterol fumarate pMDI COMBINATION_PRODUCT

Participants will receive budesonide/formoterol fumarate pMDI as oral inhalations.

Sequence AB; Sequence BA

Budesonide/formoterol fumarate Aerosphere COMBINATION_PRODUCT

Participants will receive budesonide/formoterol fumarate aerosphere as oral inhalations.

Sequence AB; Sequence BA

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants who have clinician-diagnosed asthma for at least 3 months.
• Body mass index ≤ 95 percentile for age and body weight of at least 15 kg or higher.
• Be on a stable dose of one of the following asthma treatments for at least 4 weeks prior to screening (Visit 1):
• Short-acting β2 agonist (SABA) used as rescue/reliever medication (as needed) only.
• Low- or medium-dose inhaled corticosteroids (ICS).
• Leukotriene receptor antagonist (LTRA).
• Low-dose ICS/long-acting β2-agonist (LABA).
• Medium-dose ICS/LABA.
• Female participants who experience menarche must have a negative urine pregnancy test at screening.

You may not qualify if:

• Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, or other severe respiratory abnormalities other than asthma.
• History of life-threatening asthma defined as any asthma episode associated with loss of consciousness, intubation or admission to an intensive care unit.
• History of severe asthma exacerbation within 8 weeks of Visit 1.
• Inability to change from any budesonide therapy to another suitable corticosteroid.
• Participants with a known hypersensitivity to budesonide and/or formoterol fumarate or any of the excipients of the product.
• Not be able to refrain from consuming alcohol and smoking (including electronic cigarettes, vaping, and marijuana) from the time of screening until after the safety follow-up visit.
• Unstable asthma.
• Received regular maintenance treatment with prohibited anti-inflammatory or long-acting bronchodilator asthma medication.
• Evidence of active liver disease.
• Prolonged QT interval corrected for heart rate using Fridericia's correction (QTcF).

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (6)

Research Site

Long Beach, California, 90815, United States

Location

Research Site

Miami, Florida, 33175, United States

Location

Research Site

Lafayette, Louisiana, 70508, United States

Location

Research Site

Toledo, Ohio, 43617, United States

Location

Research Site

Boerne, Texas, 78006, United States

Location

Research Site

El Paso, Texas, 79903, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 25, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): October 23, 2026
• Study Completion (Estimated): October 23, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (6)