Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)

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. Documented history of physician-diagnosed asthma > and/or = 1 year prior to V1.

3. Regularly using a stable daily ICS/LABA regimen (including a stable ICS dose) withmedium-to-high ICS doses for at least 4 weeks prior to V1.

4. ACQ-7 total score ≥1.5 at Visits 1, 3, and 5 (pre-randomization).

5. FEV1 % (assessed as an average of the 60 and 30 minute pre-dose assessments)predicted normal at V1, 2, 3, 4, and 5 (pre-randomization)

• Participants ≥ 18 years of age: < 80%

• Participants 12 to <18 years of age: < 90%

6. FEV1 post-albuterol at V2 or V3 (if repeat needed).

• Participants > and/or = 18 years of age: Increase > and/or = 12% and > and/or = 200 mL.

• Participants 12 to <18 years of age: Increase =12% either in the 12 monthsprior to Visit 1 or at Visit 2, or at Visit 3.

• Note: Even if there is documented history of reversibility, all participantsmust be assessed for reversibility at Visit 2 (and Visit 3, if reversibility isnot demonstrated at Visit 2) to provide reversibility baseline data forcharacterization.

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

8. Demonstrate acceptable MDI/pMDI administration technique.

9. Received no asthma medication other than run-in BFF MDI BID and albuterol as neededduring screening (except for allowed medications as defined in Table 9 and systemiccorticosteroid or ICS for the treatment of an asthma exacerbation).

10. eDiary 14-day compliance ≥70% during screening (defined as completing the dailyeDiary for any 10 mornings and any 10 evenings and answering "Yes" to taking 2 puffsof run-in BFF MDI for any 10 mornings and 10 evenings in the last 14 days prior torandomization).

11. No respiratory infection in the 4 weeks prior to randomization, or asthmaexacerbation treated with systemic corticosteroid and/or additional ICS treatment inthe 4 weeks prior to randomization.

Exclusion Criteria:

1. Completed treatment for respiratory infection or asthma exacerbation with systemiccorticosteroids within 4 weeks of V1.

2a. Participants where, in the opinion of the Investigator, treatment with biological therapy for asthma would be appropriate.

2b. Any marketed or investigational biologics within 3 months or 5 half-lives of V1, whichever is longer and must not be used during study duration.

3. Current smokers, former smokers with >10 pack-years history, or former smokers whostopped smoking <6 months prior to V1 (including all forms of tobacco, e-cigarettesor other vaping devices, and marijuana).

4. Current evidence of Chronic Obstructive Pulmonary Disease (COPD).

5a. Oral and IV corticosteroid use (any dose) within 4 weeks of V1.

5b. Use of systemic corticosteroids for any other reason except for the acute treatment of severe asthma exacerbation is prohibited for the duration of the study.

5c. Depot corticosteroid use for any reason within 3 months of V1.

6. Use of Long-Acting Muscarinic Antagonist (LAMA), either alone or as part of aninhaled combination therapy, in the 12 weeks prior to V1.

7. Use of oral beta2-agonist within 3 months of V1.

8. Use of any immunomodulators or immunosuppressive medication within 3 months or 5half-lives, whichever is longer, and must not be used during the study duration.

9. Narrow angle glaucoma not adequately treated and/or change in vision that may berelevant, in the opinion of the Investigator, within 3 months of Visit 1.

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

11. Hospitalization for asthma within 2 months of Visit 1.

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

13. Regular use of a nebulizer or a home nebulizer for receiving asthma medications.

14. Using any herbal products by inhalation or nebulizer within 4 weeks of Visit 1 anddoes not agree to stop during the study duration.

15. 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 the protocol is prohibited for use during study duration.

16. Participants with a known hypersensitivity to beta2-agonists, corticosteroids,anticholinergics, or any component of the MDI or pMDI.

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

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

Please refer to the study protocol for the complete inclusion and exclusion criteria list.