Asthma Clinical Trial
Official title:
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
| Status | Recruiting |
| Enrollment | 1125 |
| Est. completion date | July 1, 2019 |
| Est. primary completion date | July 1, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Have a documented history of physician-diagnosed asthma - Require inhaled asthma maintenance therapy: has been regularly using an ICS/LABA for at least 3 months, and on a stable regimen for at least 4 weeks prior - Documented reversibility to albuterol - A pre-bronchodilator FEV1 of >40% and <80% predicted normal value - 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 14 days - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Albany | Georgia |
| United States | Research Site | Albuquerque | New Mexico |
| United States | Research Site | Allen | Texas |
| United States | Research Site | Anaheim | California |
| United States | Research Site | Anderson | South Carolina |
| United States | Research Site | Ann Arbor | Michigan |
| United States | Research Site | Asheville | North Carolina |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Aventura | Florida |
| United States | Research Site | Bakersfield | California |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Bangor | Maine |
| United States | Research Site | Beaumont | Texas |
| United States | Research Site | Bellevue | Nebraska |
| United States | Research Site | Bellevue | Nebraska |
| United States | Research Site | Berlin | New Jersey |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Boerne | Texas |
| United States | Research Site | Brandon | Florida |
| United States | Research Site | Bronx | New York |
| United States | Research Site | Brownsburg | Indiana |
| United States | Research Site | Centennial | Colorado |
| United States | Research Site | Chandler | Arizona |
| United States | Research Site | Charleston | South Carolina |
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Chesterfield | Missouri |
| United States | Research Site | Chevy Chase | Maryland |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Clackamas | Oregon |
| United States | Research Site | Clearwater | Florida |
| United States | Research Site | Clearwater | Florida |
| United States | Research Site | Colorado Springs | Colorado |
| United States | Research Site | Colorado Springs | Colorado |
| United States | Research Site | Colorado Springs | Colorado |
| United States | Research Site | Columbia | Missouri |
| United States | Research Site | Columbus | Ohio |
| United States | Research Site | Columbus | Georgia |
| United States | Research Site | Corona | California |
| United States | Research Site | Costa Mesa | California |
| United States | Research Site | Crowley | Louisiana |
| United States | Research Site | Dacula | Georgia |
| United States | Research Site | Dakota Dunes | South Dakota |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Dayton | Ohio |
| United States | Research Site | Dayton | Ohio |
| United States | Research Site | Duluth | Georgia |
| United States | Research Site | Easley | South Carolina |
| United States | Research Site | Edina | Minnesota |
| United States | Research Site | Edmond | Oklahoma |
| United States | Research Site | El Paso | Texas |
| United States | Research Site | Fargo | North Dakota |
| United States | Research Site | Fargo | North Dakota |
| United States | Research Site | Farmington Hills | Michigan |
| United States | Research Site | Fort Mitchell | Kentucky |
| United States | Research Site | Franklin | Tennessee |
| United States | Research Site | Fridley | Minnesota |
| United States | Research Site | Fullerton | California |
| United States | Research Site | Gaffney | South Carolina |
| United States | Research Site | Gaffney | South Carolina |
| United States | Research Site | Gainesville | Florida |
| United States | Research Site | Gainesville | Georgia |
| United States | Research Site | Gastonia | North Carolina |
| United States | Research Site | Gastonia | North Carolina |
| United States | Research Site | Gold River | California |
| United States | Research Site | Greenfield | Wisconsin |
| United States | Research Site | Greensboro | North Carolina |
| United States | Research Site | Greenville | South Carolina |
| United States | Research Site | Grove City | Ohio |
| United States | Research Site | Guntersville | Alabama |
| United States | Research Site | Hamden | Connecticut |
| United States | Research Site | Hendersonville | North Carolina |
| United States | Research Site | Hendersonville | Tennessee |
| United States | Research Site | Hialeah | Florida |
| United States | Research Site | Hialeah | Florida |
| United States | Research Site | Hialeah | Florida |
| United States | Research Site | Hickory | North Carolina |
| United States | Research Site | Highland Park | New Jersey |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Huntersville | North Carolina |
| United States | Research Site | Huntington Beach | California |
| United States | Research Site | Kerrville | Texas |
| United States | Research Site | Killeen | Texas |
| United States | Research Site | Kingsport | Tennessee |
| United States | Research Site | Kissimmee | Florida |
| United States | Research Site | Lafayette | Colorado |
| United States | Research Site | Lake City | Florida |
| United States | Research Site | Lampasas | Texas |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Lawrenceville | Georgia |
| United States | Research Site | Lincoln | Nebraska |
| United States | Research Site | Little Rock | Arkansas |
| United States | Research Site | Little Rock | Arkansas |
| United States | Research Site | Live Oak | Texas |
| United States | Research Site | Long Beach | California |
| United States | Research Site | Long Beach | California |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Loxahatchee Groves | Florida |
| United States | Research Site | Lufkin | Texas |
| United States | Research Site | Marion | Ohio |
| United States | Research Site | Medford | Oregon |
| United States | Research Site | Meridian | Idaho |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Minneapolis | Minnesota |
| United States | Research Site | Minneapolis | Minnesota |
| United States | Research Site | Mission Viejo | California |
| United States | Research Site | Monroe | North Carolina |
| United States | Research Site | Monroeville | Pennsylvania |
| United States | Research Site | Mooresville | North Carolina |
| United States | Research Site | Mount Pleasant | South Carolina |
| United States | Research Site | Murray | Utah |
| United States | Research Site | New Bern | North Carolina |
| United States | Research Site | New York | New York |
| United States | Research Site | Newport Beach | California |
| United States | Research Site | Newport News | Virginia |
| United States | Research Site | Norcross | Georgia |
| United States | Research Site | North Dartmouth | Massachusetts |
| United States | Research Site | Ocala | Florida |
| United States | Research Site | Ocean City | New Jersey |
| United States | Research Site | Ocoee | Florida |
| United States | Research Site | Omaha | Nebraska |
| United States | Research Site | Omaha | Nebraska |
| United States | Research Site | Orange | California |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Palmdale | California |
| United States | Research Site | Panama City | Florida |
| United States | Research Site | Pearland | Texas |
| United States | Research Site | Pembroke Pines | Florida |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Plano | Texas |
| United States | Research Site | Plymouth | Minnesota |
| United States | Research Site | Portland | Oregon |
| United States | Research Site | Poway | California |
| United States | Research Site | Quartz Hill | California |
| United States | Research Site | Raleigh | North Carolina |
| United States | Research Site | Rancho Mirage | California |
| United States | Research Site | Rapid City | South Dakota |
| United States | Research Site | Reno | Nevada |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Rincon | Georgia |
| United States | Research Site | River Forest | Illinois |
| United States | Research Site | Riverside | California |
| United States | Research Site | Rock Hill | South Carolina |
| United States | Research Site | Rock Hill | South Carolina |
| United States | Research Site | Rolling Hills Estates | California |
| United States | Research Site | Sacramento | California |
| United States | Research Site | Sacramento | California |
| United States | Research Site | Saint Cloud | Florida |
| United States | Research Site | Saint Louis | Missouri |
| United States | Research Site | Salt Lake City | Utah |
| United States | Research Site | Salt Lake City | Utah |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Diego | California |
| United States | Research Site | San Diego | California |
| United States | Research Site | San Diego | California |
| United States | Research Site | San Jose | California |
| United States | Research Site | Seneca | South Carolina |
| United States | Research Site | Sherman | Texas |
| United States | Research Site | Skillman | New Jersey |
| United States | Research Site | Smyrna | Tennessee |
| United States | Research Site | South Burlington | Vermont |
| United States | Research Site | Spartanburg | South Carolina |
| United States | Research Site | Spartanburg | South Carolina |
| United States | Research Site | Spokane | Washington |
| United States | Research Site | Spokane Valley | Washington |
| United States | Research Site | Stockton | California |
| United States | Research Site | Sunset | Louisiana |
| United States | Research Site | Tacoma | Washington |
| United States | Research Site | Tallahassee | Florida |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | Tempe | Arizona |
| United States | Research Site | Thousand Oaks | California |
| United States | Research Site | Toms River | New Jersey |
| United States | Research Site | Tucson | Arizona |
| United States | Research Site | Tulsa | Oklahoma |
| United States | Research Site | Union | South Carolina |
| United States | Research Site | Virginia Beach | Virginia |
| United States | Research Site | Waco | Texas |
| United States | Research Site | Warwick | Rhode Island |
| United States | Research Site | Waterbury | Connecticut |
| United States | Research Site | West Allis | Wisconsin |
| United States | Research Site | Westminster | California |
| United States | Research Site | White Marsh | Maryland |
| United States | Research Site | Winston-Salem | North Carolina |
| United States | Research Site | Winter Park | Florida |
| United States | Research Site | Winter Park | Florida |
| United States | Research Site | Woodbury | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 4 hours (AUC0-4) | Week 24 | ||
| Secondary | Change from baseline in morning pre-dose trough FEV1 | Week 24 | ||
| Secondary | Time to first moderate/severe asthma exacerbation | Over 24 Weeks | ||
| Secondary | Change from baseline in Asthma Control Questionnaire (ACQ)-7 | Asthma Control Questionnaire (ACQ)-7, each of the 6 questions and 1 value (FEV1 % predicted) is scored on a 7 point scale. The scale range is from 0-6. 0 is no impairment, 6 is the maximum impairment. The ACQ score is the mean of the item responses. | Week 24 | |
| Secondary | Change from baseline in Asthma Control Questionnaire 5 (ACQ-5) | Asthma Control Questionnaire (ACQ)-5, each of the 5 questions is scored on a 7 point scale. The scale range is from 0-6. 0 is no impairment, 6 is the maximum impairment. The ACQ score is the mean of the item responses. | Week 24 | |
| Secondary | Change from baseline in Asthma Quality of Life Questionnaire for 12 years and older (AQLQ +12) | Asthma Quality of Life Questionnaire for 12 years and older (AQLQ +12). There are 32 questions in 4 different domains (Symptoms, Activity Limitation, Emotional Function, and Environmental Stimuli). Each of the questions is scored on a 7 point scale. The scale range is from 1-7. 7 is no impairment, 1 is severe impairment. The overall score is the mean of all 32 responses, and the individual domain scores, are the mean of the items in the domains. | Week 24 |
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