Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pearl Therapeutics, Inc.
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
Age
12–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
