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

• Status: Completed
• Trial end date: 2019-09-12
• Target enrollment: 0
• Participant gender: All

Summary

Study Comparing the Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistent Asthma

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pearl Therapeutics, Inc.
• Treatments: Tiotropium Bromide

Criteria

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