A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants With Inadequately Controlled Asthma (VATHOS)

Inclusion Criteria:

1. 12 to 80 years of age, male and female, BMI <40 kg/m2; females must be not ofchildbearing potential or using a form of highly effective birth control.

2. Participants who have a documented history of physician-diagnosed asthma ≥ 6 monthsprior to Visit 1, according to GINA guidelines [GINA 2020]. Healthcare records forone year prior to Visit 1 must be provided for adolescent participants (12 to < 18years of age) to ensure consistent evaluation and follow-up of treatment in thoseparticipants.

3. Participants who have been regularly using a stable daily ICS or an ICS/LABA regimen (including a stable ICS dose), with the ICS doses, for at least 8 weeks prior toVisit 1.

4. ACQ-7 total score ≥ 1.5 at Visits 1 and 4.

5. Pre-bronchodilator/pre-dose FEV1 <90% predicted normal value at Visits 1, 2 and 3,and a pre-dose FEV1 of 50% to 90% at Visit 4 (pre-randomization).

6. Reversibility to albuterol, defined as a post-albuterol increase in FEV1 of ≥ 12%and ≥ 200 mL for participants ≥ 18 years of age OR a post-albuterol increase in FEV1of ≥ 12% for participants 12 to < 18 years of age, either in the 12 months prior toVisit 1 or at Visit 2 or Visit 3.

7. A pre-bronchodilator/pre-dose FEV1 at Visits 2, 3, and 4 that have not changed 20%or more (increase or decrease) from the pre-bronchodilator/pre-dose FEV1 recorded atthe previous visit.

8. Asthma stability during run-in based on Investigator discretion using the symptomworsening assessment.

9. Willing and, in the opinion of the Investigator, able to adjust current asthmatherapy, as required by the protocol.

10. Demonstrate acceptable MDI administration technique.

11. eDiary compliance ≥ 70% during screening, defined as completing the daily eDiary andanswering "Yes" to taking 2 puffs of run-in BD MDI for any 10 mornings and 10evenings in the last 14 days prior to randomization.

Exclusion Criteria:

1. Life-threatening asthma as defined as a history of significant asthma episode(s)requiring intubation associated with hypercapnia, respiratory arrest, hypoxicseizures, or asthma related syncopal episode(s).

2. Any respiratory infection or asthma exacerbation treated with systemiccorticosteroids and/or additional ICS treatment in the 8 weeks prior to Visit 1 andthroughout the Screening Period.

3. Hospitalization for asthma within 8 weeks of Visit 1.

4. Historical or current evidence of a clinically significant disease including, butnot limited to: cardiovascular, hepatic, renal, hematological, neurological,endocrine, gastrointestinal, or pulmonary (eg, active tuberculosis, bronchiectasis,pulmonary eosinophilic syndromes, and COPD). Significant is defined as any diseasethat, in the opinion of the Investigator, would put the safety of the participant atrisk through participation, or that could affect the efficacy or safety analysis.

5. Known history of drug or alcohol abuse within 12 months of Visit 1.

6. Unresectable cancer that has not been in complete remission for at least 5 yearsprior to Visit 1.

7. Participation in another clinical study with a study intervention administered inthe last 30 days or 5 half-lives, whichever is longer. Any other study interventionthat is not identified in this protocol is prohibited for use during study duration.

8. Previous or current randomization into studies within the AEROSPHERE programincluding KALOS, LOGOS, VATHOS, LITHOS, or any glycopyrronium studies (PT001).

9. Use of a nebulizer or a home nebulizer for receiving asthma medications.

10. Do not meet the stable dosing period prior to Visit 1 or unable to abstain fromprotocol-defined prohibited medications during Screening and Treatment Periods.

11. Receipt of COVID-19 vaccine (regardless of vaccine delivery platform, eg, vector,lipid nanoparticle) < 7 days prior to Visit 1 (from last vaccination or boosterdose).

12. Participants with known hypersensitivity to beta2-agonists, corticosteroids, or anycomponent of the MDI.

13. Any clinically relevant abnormal findings in physical examination, clinicalchemistry, hematology, vital signs, or ECG, which in the opinion of theInvestigator, may put the participant at risk because of his/her participation inthe study.

14. Current smokers, former smokers with > 10 pack-years history, or former smokers whostopped smoking < 6 months prior to Visit 1 (including all forms of tobacco,e-cigarettes or other vaping devices, and marijuana).

15. Planned hospitalization during the study.

16. Involvement in the planning and/or conduct of the study (applies to both AstraZenecastaff and/or staff at the study site).

17. Study Investigators, sub-Investigators, coordinators, and their employees orimmediate family members.

18. Judgment by the Investigator that the participant is unlikely to comply with studyprocedures, restrictions, and requirements.

19. For women only - currently pregnant (confirmed with positive highly sensitive urinepregnancy test), breast-feeding, or planned pregnancy during the study or not usingacceptable contraception measures, as judged by the Investigator.