Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07433569
Eligibility Criteria:
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
12 Years
Study:
NCT07433569
Study Brief:
Protocol Section:
NCT07433569