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

Korábbi kezelés

• Inability to change from any budesonide therapy to another suitable corticosteroid.
• Received regular maintenance treatment with prohibited anti-inflammatory or long-acting bronchodilator asthma medication.

Más betegség

• 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.
• Participants with a known hypersensitivity to budesonide and/or formoterol fumarate or any of the excipients of the product.
• Evidence of active liver disease.

Laborértékek

• Prolonged QT interval corrected for heart rate using Fridericia's correction (QTcF).

Egyéb

• 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.

• 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.