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

Inclusion Criteria:

• Have a documented history of physician-diagnosed asthma

• Require inhaled asthma maintenance therapy: has been regularly using an ICS/LABA forat least 3 months, and on a stable regimen for at least 4 weeks prior

• Documented reversibility to albuterol

• A pre-bronchodilator FEV1 of >40% and <80% predicted normal value

• Demonstrate acceptable spirometry performance

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

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

Exclusion Criteria:

• Oral corticosteroid use (any dose) within 14 days

• Current smokers, former smokers with >10 pack-years history, or former smokers whostopped smoking <6 months (including all forms of tobacco, e-cigarettes, andmarijuana)

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

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

• 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 withinthe last 30 days or 5 half-lives, whichever is longer

• Previously randomized in any PT001 study