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Recruiting Phase 1 NCT07433569

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

Phase 1 – testing safety in a small group of people
Conditions: Asthma

Sponsor: AstraZeneca

trial.available_in: БГ
Overview
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.
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.
Who can participate
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).
Interventions
Budesonide/formoterol fumarate Aerosphere
COMBINATION_PRODUCT
Budesonide/formoterol fumarate pMDI
COMBINATION_PRODUCT
Locations 6
United States (6)
Research Site
Boerne , Texas
Research Site
El Paso , Texas
Research Site
Lafayette , Louisiana
Research Site
Long Beach , California
Research Site
Miami , Florida
Research Site
Toledo , Ohio
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
4 Years
Maximum age
12 Years
Healthy volunteers
No
Start date
05.03.2026
Completion date
23.10.2026
Registry ID
NCT07433569
Source
clinicaltrials.gov
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