A Study Evaluating the Effect of Inhaled PT007(AS MDI) Versus Placebo MDI and Ventolin Evohaler on Lung Function in Adult Participants with Asthma - MITCHELL

Exclusion Criteria

• 5.2 Exclusion Criteria
• Participants are excluded from the study if any of the following criteria apply:
• Medical Conditions and History
• 1 Any evidence of chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the participant at risk through participation, or that could affect the efficacy or safety analysis.
• 2 Life-threatening asthma 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 the last 5 years.
• 3 Upper respiratory infection not resolved within 7 days of Visit 1 and throughout the screening period.
• 4 Hospitalizations for asthma exacerbation within the last 3 months prior to Visit 1.
• 5 Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (eg, congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia, participants with known QTcF ≥ 480 ms, coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (eg, uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison’s disease, Cushing’s syndrome), or gastrointestinal (eg, poorly controlled peptic ulcer, gastroesophageal reflux disease). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the participant at risk through study participation, or that could affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
• 6 Cancer not in complete remission for at least 5 years prior to Visit 1.
• Note: Participants with squamous cell carcinoma of the skin or basal cell carcinoma of the skin or cervical carcinoma in situ are eligible, if in the opinion of the investigator, the condition has been adequately worked up and clinically controlled, and the participant’s participation in the study would not represent a safety concern.
• 7 Hospitalized for psychiatric disorder or attempted suicide within one year prior to Visit 1.
• 8 History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions limiting informed consent validity.
• 9 Received a live attenuated vaccination within 7 days of Visit 1.
• Prior/Concomitant Therapy
• 10 Oral/systemic corticosteroid use (any dose) within 6 weeks of Visit 1.
• 11 Chronic use of oral corticosteroids (≥ 3 weeks use in the 3 months prior to Visit 1).
• 12 Received any marketed (eg, omalizumab, mepolizumab, reslizumab) or investigational biologic within 3 months or 5 half-lives, whichever is longer, or any other medication specifically prohibited by the protocol within the indicated exclusionary time periods.
• 13 Received tiotropium within 2 weeks of Visit 1.
• 14 Received treatment for lower respiratory infection or asthma exacerbation within 6 weeks of Visit 1.
• 15 Unable to abstain from protocol-defined prohibited medications during screening and the study.
• 16 Using any herbal products by inhalation or nebulizer within 2 weeks of Visit 1 and does not agree to stop during the study duration.
• Prior/Concurrent Clinical Study Experience
• 17 Treatment with investigational study intervention (or device) in another clinical study within the last 30 days or 5 half-lives, whichever is longer, prior to Visit 1.
• 18 Hypersensitivity to β2-agonists or any component of the investigational MDI or any component of Ventolin Evohaler or HFA (or Pulmicort Flexhaler, if applicable).
• Other Exclusions
• 19 Significant abuse of alcohol or drugs in the opinion of the investigator.
• 20 Current smokers, former smokers with > 10 pack-years history, or former smokers who stopped smoking < 6 months (including all forms of tobacco, e-cigarettes [vaping], and marijuana).
• 21 Study investigators, sub-investigators, coordinators, and their employees or immediate family members, or employees of the sponsor.
• 22 Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
• 23 For female participants only: currently pregnant (confirmed with positive pregnancy test) or breastfeeding.