Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Asthma

This is a 5-period crossover study. Each Treatment Period is 1 day. Subjects will receive a
single dose of randomized study drug at each of the 5 Treatment Visits (Visits 2, 3, 4, 5,
and 6), with a 3- to 7-day Washout Period between Treatment Visits.

Inclusion Criteria

- Are at least 12 years of age and no older than 65 years

- Have stable (for 6 months) physician-diagnosed asthma with historical documentation of
the diagnosis

- Must be receiving 1 of the following required inhaled asthma therapies listed below
for at least the last 30 days; Only SABA, which is used as needed for rescue, or Low
to medium doses of ICS (alone or in combination with LABA), used regularly as
maintenance asthma therapy

- Demonstrate acceptable spirometry performance (ie, meet American Thoracic Society
[ATS]/European Respiratory Society [ERS] acceptability/repeatability criteria

- Pre-bronchodilator FEV1 of ≥40 to <90% predicted normal value after withholding SABA
for ≥6 hours

- Confirmed FEV1 reversibility to Ventolin, defined as a post-Ventolin increase in FEV1
of ≥15%

- only 2 reversibility testing attempts are allowed

Exclusion Criteria:

- Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic
bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or
bronchopulmonary dysplasia)

- Oral corticosteroid use (any dose) within 6 weeks

- 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)

- 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)

- Historical or current evidence of a clinically significant disease

- Cancer not in complete remission for at least 5 years

- Hospitalized for psychiatric disorder or attempted suicide within 1 year

- Unable to abstain from protocol-defined prohibited medications during the study