Status:
COMPLETED
Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistant Asthma
Lead Sponsor:
Pearl Therapeutics, Inc.
Conditions:
Asthma
Eligibility:
All Genders
12-80 years
Phase:
PHASE2
PHASE3
Brief Summary
Study Comparing the Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistent Asthma
Detailed Description
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 Persisten...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2019
Estimated Enrollment :
1077 Patients enrolled
Trial Details
Trial ID
NCT03358147
Start Date
December 13 2017
End Date
September 12 2019
Last Update
August 12 2020
Active Locations (232)
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1
Research Site
Birmingham, Alabama, United States, 35209
2
Research Site
Birmingham, Alabama, United States, 35243
3
Research Site
Dothan, Alabama, United States, 36303
4
Research Site
Guntersville, Alabama, United States, 35976