Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistant Asthma

A Randomized, Double-Blind, Parallel Group, Multi-Center 24-Week Study Comparing the Efficacy
and Safety of Three Doses of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects
With Persistent Asthma

Inclusion Criteria:

- Have a documented history of physician-diagnosed asthma

- Require inhaled asthma maintenance therapy: has been regularly using an ICS/LABA on a
stable regimen for at least 4 weeks

- Documented reversibility to albuterol

- A pre-bronchodilator FEV1 >40% and <85% of predicted normal value for subjects 18 to
80 years of age or >40% and <90% of predicted for subjects 12 to <18 years of age

- Demonstrate acceptable spirometry performance

- Willing and, in the opinion of the Investigator, able to adjust current asthma
therapy, as required by the protocol

- Compliance: must be willing to remain at the study center as required per protocol to
complete all visit assessments

Exclusion Criteria:

- Oral corticosteroid use (any dose) within 4 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, and
marijuana)

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

- Completed treatment for lower respiratory infection or asthma exacerbation within 4
weeks

- Hospitalizations for asthma within 3 months

- Historical or current evidence of a clinically significant disease

- Cancer not in complete remission for at least 5 years

- Treatment with investigational study drug (or device) in another clinical study within
the last 30 days or 5 half-lives, whichever is longer

- Previously randomized in any PT001 study