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

Exclusion Criteria

• •1\. Completed treatment for respiratory infection or asthma exacerbation with systemic corticosteroids 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 who stopped smoking \<6 months prior to V1 (including all forms of tobacco, e-cigarettes or 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 an inhaled 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 5 half-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 be relevant, 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, hypoxic seizures, 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 and does not agree to stop during the study duration.
• •15\. Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer. Any other study intervention that 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 or immediate family members.
• •18\. For women only - currently pregnant (confirmed with positive highly sensitive pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator.