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 (COMPAIR)

Phase I Study to Compare the Pharmacokinetics of Budesonide and Formoterol Delivered With Symbicort Aerosphere® and Symbicort® pMDI in Children 4 to Less Than 12 Years of Age With Asthma

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma
• Intervention / Treatment: Combination product: Budesonide/formoterol fumarate Aerosphere; Combination product: Budesonide/formoterol fumarate pMDI

Detailed Description

This is a phase I single-dose, 2-period cross-over, multicenter study in which the participants will be randomized 1:1 to one of two treatment sequences - AB or BA. In the first study period, participants will receive a single dose of either -

1. Treatment A: Symbicort Aerosphere budesonide/formoterol fumarate × 2 puffs (test formulation)
2. Treatment B: Symbicort pMDI budesonide/formoterol fumarate × 2 puffs (reference formulation)

After a washout period of at least 28 days and no longer than 42 days, participants who first received Treatment A will receive a single dose of Treatment B, and participants who first received Treatment B will receive a single dose of Treatment A in the study period 2.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90815
      • Research Site
  • Florida
    • Miami, Florida, United States, 33175
      • Research Site
  • Louisiana
    • Lafayette, Louisiana, United States, 70508
      • Research Site
  • Ohio
    • Toledo, Ohio, United States, 43617
      • Research Site
  • Texas
    • Boerne, Texas, United States, 78006
      • Research Site
    • El Paso, Texas, United States, 79903
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• 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):

  1. Short-acting β2 agonist (SABA) used as rescue/reliever medication (as needed) only.
  2. Low- or medium-dose inhaled corticosteroids (ICS).
  3. Leukotriene receptor antagonist (LTRA).
  4. Low-dose ICS/long-acting β2-agonist (LABA).
  5. Medium-dose ICS/LABA.
• Female participants who experience menarche must have a negative urine pregnancy test at screening.

Key Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence AB; 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; Participants will receive budesonide/formoterol fumarate aerosphere as oral inhalations.; Combination product: Budesonide/formoterol fumarate pMDI; Participants will receive budesonide/formoterol fumarate pMDI as oral inhalations.
Experimental: Sequence BA; 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; Participants will receive budesonide/formoterol fumarate aerosphere as oral inhalations.; Combination product: Budesonide/formoterol fumarate pMDI; Participants will receive budesonide/formoterol fumarate pMDI as oral inhalations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to reach peak or maximum observed concentration or response following drug administration (tmax)	To determine and compare tmax for 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
Terminal elimination rate constant (λz)	To determine and compare λz for 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
Terminal elimination half-life (t½λz)	To determine and compare t½λz for 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 plasma concentration-time curve from time 0 to infinity (AUCinf)	To determine and compare AUCinf for 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
Mean residence time (MRT)	To determine and compare MRT for 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
Apparent total body clearance (CL/F)	To determine and compare CL/F for 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
Apparent volume of distribution based on the terminal phase (Vz/F)	To determine and compare Vz/F for 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
Number of participants with adverse events	To assess the safety and tolerability of single doses of Symbicort Aerosphere and Symbicort pMDI in participants 4 to less than 12 years of age with asthma.	From Screening (Day -14 to Day -1) to Follow-up telephone call (approximately 7 weeks)
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)	To determine and compare AUClast for 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

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2026
• Primary Completion (Estimated): October 23, 2026
• Study Completion (Estimated): October 23, 2026

Study Registration Dates

• First Submitted: February 20, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Pediatric; Pharmacokinetics; Formoterol; Budesonide; Symbicort Aerosphere; Symbicort pressurized metered dose inhaler (pMDI)
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Polycyclic Compounds; Pregnanes; Steroids; Fused-Ring Compounds; Pregnenediones; Pregnenes; Budesonide
• Other Study ID Numbers: D7820C00005; 5570196 (Other Identifier: Pediatric Study Plan Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing 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.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes