Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistant Asthma
Launched by PEARL THERAPEUTICS, INC. · Nov 29, 2017
Trial Information
Current as of May 19, 2025
Completed
Keywords
ClinConnect Summary
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
Gender
ALL
Eligibility 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
About Pearl Therapeutics, Inc.
Pearl Therapeutics, Inc. is a biopharmaceutical company focused on the development of innovative therapeutic solutions for respiratory diseases. Leveraging advanced drug delivery technologies, Pearl Therapeutics aims to enhance patient outcomes through the formulation of novel inhalation therapies. The company is committed to addressing unmet medical needs in the treatment of conditions such as chronic obstructive pulmonary disease (COPD) and asthma, with a robust pipeline of clinical programs designed to optimize efficacy and patient adherence. With a strong emphasis on scientific excellence and collaboration, Pearl Therapeutics is dedicated to advancing healthcare through the discovery and development of next-generation respiratory therapeutics.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Raleigh, North Carolina, United States
Smyrna, Tennessee, United States
Tulsa, Oklahoma, United States
Greenville, South Carolina, United States
Poway, California, United States
Kissimmee, Florida, United States
Wooster, Ohio, United States
Saint Louis, Missouri, United States
Medford, Oregon, United States
Tacoma, Washington, United States
Little Rock, Arkansas, United States
Mission Viejo, California, United States
Wheat Ridge, Colorado, United States
Jasper, Alabama, United States
Huntington Beach, California, United States
Stockton, California, United States
Tampa, Florida, United States
Ann Arbor, Michigan, United States
Minneapolis, Minnesota, United States
Albuquerque, New Mexico, United States
Charlotte, North Carolina, United States
Dallas, Texas, United States
Birmingham, Alabama, United States
Encinitas, California, United States
Colorado Springs, Colorado, United States
Cincinnati, Ohio, United States
Ocoee, Florida, United States
New York, New York, United States
Corona, California, United States
Fullerton, California, United States
Omaha, Nebraska, United States
Elizabeth City, North Carolina, United States
Waco, Texas, United States
South Burlington, Vermont, United States
Abingdon, Virginia, United States
Fargo, North Dakota, United States
Orange, California, United States
Anaheim, California, United States
Los Angeles, California, United States
North Dartmouth, Massachusetts, United States
Burlington, North Carolina, United States
Gastonia, North Carolina, United States
New Bern, North Carolina, United States
Winston Salem, North Carolina, United States
Wyomissing, Pennsylvania, United States
Anderson, South Carolina, United States
Bellingham, Washington, United States
Palmdale, California, United States
Savannah, Georgia, United States
Skillman, New Jersey, United States
Centennial, Colorado, United States
Aventura, Florida, United States
Ocala, Florida, United States
Tallahassee, Florida, United States
San Jose, California, United States
Greenfield, Wisconsin, United States
East Providence, Rhode Island, United States
Rancho Mirage, California, United States
Charleston, South Carolina, United States
Panama City, Florida, United States
Gaffney, South Carolina, United States
Johnson City, Tennessee, United States
San Antonio, Texas, United States
Morgantown, West Virginia, United States
Greensboro, North Carolina, United States
Murray, Utah, United States
Chandler, Arizona, United States
Winter Park, Florida, United States
Warwick, Rhode Island, United States
Franklin, Tennessee, United States
Tomball, Texas, United States
Michigan City, Indiana, United States
Sacramento, California, United States
Clearwater, Florida, United States
Hialeah, Florida, United States
Shreveport, Louisiana, United States
Amarillo, Texas, United States
Huntersville, North Carolina, United States
Mount Pleasant, South Carolina, United States
Austin, Texas, United States
Newport News, Virginia, United States
Phoenix, Arizona, United States
Chesterfield, Missouri, United States
Pembroke Pines, Florida, United States
Stockbridge, Georgia, United States
Chevy Chase, Maryland, United States
Miami, Florida, United States
Rock Hill, South Carolina, United States
Loxahatchee Groves, Florida, United States
Berlin, New Jersey, United States
Tucson, Arizona, United States
El Paso, Texas, United States
Scottsboro, Alabama, United States
Gainesville, Florida, United States
Evergreen Park, Illinois, United States
Flagstaff, Arizona, United States
Newport Beach, California, United States
Thousand Oaks, California, United States
Boise, Idaho, United States
Mooresville, North Carolina, United States
Kerrville, Texas, United States
Edina, Minnesota, United States
Woodbury, Minnesota, United States
Las Vegas, Nevada, United States
Tustin, California, United States
Bangor, Maine, United States
Oklahoma City, Oklahoma, United States
Spokane Valley, Washington, United States
Columbus, Georgia, United States
Rapid City, South Dakota, United States
Boerne, Texas, United States
Marion, Ohio, United States
Lawrenceville, Georgia, United States
North Hollywood, California, United States
Bakersfield, California, United States
Northridge, California, United States
Toms River, New Jersey, United States
Lufkin, Texas, United States
Fridley, Minnesota, United States
Plano, Texas, United States
Troy, Michigan, United States
Salt Lake City, Utah, United States
El Cajon, California, United States
Brandon, Florida, United States
Ocean City, New Jersey, United States
Rolling Hills Estates, California, United States
Dublin, Ohio, United States
Portland, Oregon, United States
San Diego, California, United States
Gold River, California, United States
Westminster, California, United States
Orlando, Florida, United States
Rincon, Georgia, United States
Meridian, Idaho, United States
O'fallon, Illinois, United States
Crowley, Louisiana, United States
Zachary, Louisiana, United States
Farmington Hills, Michigan, United States
Rochester, Michigan, United States
Saint Charles, Missouri, United States
Bellevue, Nebraska, United States
Monroe, North Carolina, United States
Dayton, Ohio, United States
Hodges, South Carolina, United States
Myrtle Beach, South Carolina, United States
Union, South Carolina, United States
Hendersonville, Tennessee, United States
Houston, Texas, United States
Richmond, Virginia, United States
Saint Cloud, Florida, United States
Lafayette, Colorado, United States
Fort Mitchell, Kentucky, United States
Tempe, Arizona, United States
Carrollton, Texas, United States
Riverside, California, United States
River Forest, Illinois, United States
White Marsh, Maryland, United States
Lampasas, Texas, United States
Fresno, California, United States
Brownsburg, Indiana, United States
Albany, Georgia, United States
Hickory, North Carolina, United States
Reno, Nevada, United States
Pearland, Texas, United States
Dothan, Alabama, United States
Quartz Hill, California, United States
Atlanta, Georgia, United States
Dacula, Georgia, United States
Norcross, Georgia, United States
Bronx, New York, United States
Edmond, Oklahoma, United States
Monroeville, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Spartanburg, South Carolina, United States
Sherman, Texas, United States
Costa Mesa, California, United States
Lincoln, Nebraska, United States
Live Oak, Texas, United States
Hamden, Connecticut, United States
Lake City, Florida, United States
Clackamas, Oregon, United States
Fall River, Massachusetts, United States
Guntersville, Alabama, United States
Long Beach, California, United States
Adairsville, Georgia, United States
Columbia, Missouri, United States
Cortland, New York, United States
Watertown, New York, United States
Killeen, Texas, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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