Clinical Research Directory

Inclusion Criteria: 1. Documented physician-diagnosed asthma for at least 12 months prior to Visit 1 2. Receiving 1 of the scheduled asthma maintenance therapies for 3 months with stable dosing for at least the last 4 weeks before Visit 1 3. Pre-bronchodilator FEV1 of ≥ 40% to \< 90% predicted normal value for adults. 4. Documented reversibility to albuterol 5. A documented history of at least one severe asthma exacerbation within 12 months before Visit 1 6. ACQ-7 score ≥ 1.5 assessed at Visit 1 7. ACQ-5 score ≥ 1.5 assessed at Visit 2 8. Receiving inhaled SABA as needed prior to Visit 1 for at least 3 months 9. Use of Sponsor-provided salbutamol sulfate inhalation aerosol as needed medication due to asthma symptoms on at least 3 days during the last week of the run-in period before Visit 2 10. Demonstrate acceptable MDI administration technique as assessed by the investigator; use of spacers is prohibited 11. Able to perform acceptable and reproducible PEF measurements as assessed by the investigator 12. BMI \< 40 kg/m2 13. Negative pregnancy test (urine at Visit 1) for female participants of childbearing potential 14. Women of childbearing potential must agree to prevent pregnancy 15. Compliance: must be willing to remain at the study site as required per protocol and complete all visit assessments Exclusion Criteria: 1. Chronic obstructive pulmonary disease or other significant lung disease 2. Oral/SCS use (any dose) within 6 weeks before Visit 1 3. Chronic use of OCS ≥ 3 weeks use in 3 months prior to Visit 1 4. Having received any marketed or investigational biologic within 3 months or 5 half-lives before Visit 1, whichever is longer, or any other prohibited medication 5. Current smokers, former smokers with \> 10 pack-years history, or former smokers who stopped smoking \< 6 months before Visit 1 6. Life-threatening asthma as defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s) within last 5 years of Visit 1 7. Completed treatment for lower respiratory infection or asthma exacerbation within 6 weeks of Visit 1 8. Upper respiratory infection involving antibiotic treatment not resolved within 7 days before Visit 1 9. Clinically significant laboratory abnormalities 10. Historical or current evidence of a clinically significant disease 11. Cancer not in complete remission for at least 5 years before Visit 1 12. History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions if their magnitude is limiting informed consent validity 13. Have a known or suspected hypersensitivity to albuterol/salbutamol, or budesonide and/or their excipients 14. Inability to abstain from protocol-defined prohibited medications during the study 15. Having received a live attenuated vaccination within 7 days of Visit 1 16. Currently pregnant or breastfeeding 17. Participants who experience \> 1 asthma exacerbation during the screening period