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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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

Key facts

Study ID

NCT03358147

Run by

Pearl Therapeutics, Inc.

People needed

1077

Starts

2017-12-13

Expected to finish

2019-09-12

Last updated by the study team

2020-08-12

Who can join

Age: 12 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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
• Previously randomized in any PT001 study

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — Dothan, Alabama, United States
• Research Site — Guntersville, Alabama, United States
• Research Site — Jasper, Alabama, United States
• Research Site — Scottsboro, Alabama, United States
• Research Site — Chandler, Arizona, United States
• Research Site — Flagstaff, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Tempe, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Anaheim, California, United States
• Research Site — Bakersfield, California, United States
• Research Site — Corona, California, United States
• Research Site — Costa Mesa, California, United States
• Research Site — El Cajon, California, United States
• Research Site — Encinitas, California, United States
• Research Site — Fresno, California, United States
• Research Site — Fullerton, California, United States
• Research Site — Gold River, California, United States
• Research Site — Huntington Beach, California, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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