Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistant Asthma
Status: | Active, not recruiting |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 12 - 80 |
Updated: | 4/6/2019 |
Start Date: | December 13, 2017 |
End Date: | September 27, 2019 |
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
Study Comparing the Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat®
in Subjects With Persistent Asthma
in Subjects With Persistent 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
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
We found this trial at
202
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