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
| Verified date | August 2020 |
| Source | Pearl Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Study Comparing the Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistent Asthma
| Status | Completed |
| Enrollment | 1077 |
| Est. completion date | September 12, 2019 |
| Est. primary completion date | September 12, 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 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Abingdon | Virginia |
| United States | Research Site | Adairsville | Georgia |
| United States | Research Site | Albany | Georgia |
| United States | Research Site | Albuquerque | New Mexico |
| United States | Research Site | Albuquerque | New Mexico |
| United States | Research Site | Amarillo | 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 | Atlanta | Georgia |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Aventura | Florida |
| United States | Research Site | Bakersfield | California |
| United States | Research Site | Bangor | Maine |
| United States | Research Site | Bellevue | Nebraska |
| United States | Research Site | Bellevue | Nebraska |
| United States | Research Site | Bellingham | Washington |
| 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 | Boise | Idaho |
| United States | Research Site | Brandon | Florida |
| United States | Research Site | Bronx | New York |
| United States | Research Site | Bronx | New York |
| United States | Research Site | Brownsburg | Indiana |
| United States | Research Site | Burlington | North Carolina |
| United States | Research Site | Carrollton | Texas |
| 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 | 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 | Columbia | Missouri |
| United States | Research Site | Columbus | Ohio |
| United States | Research Site | Columbus | Georgia |
| United States | Research Site | Corona | California |
| United States | Research Site | Cortland | New York |
| United States | Research Site | Costa Mesa | California |
| United States | Research Site | Crowley | Louisiana |
| United States | Research Site | Dacula | Georgia |
| 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 | Dothan | Alabama |
| United States | Research Site | Dublin | Ohio |
| United States | Research Site | East Providence | Rhode Island |
| United States | Research Site | Edina | Minnesota |
| United States | Research Site | Edmond | Oklahoma |
| United States | Research Site | El Cajon | California |
| United States | Research Site | El Paso | Texas |
| United States | Research Site | Elizabeth City | North Carolina |
| United States | Research Site | Encinitas | California |
| United States | Research Site | Evergreen Park | Illinois |
| United States | Research Site | Fall River | Massachusetts |
| 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 | Flagstaff | Arizona |
| United States | Research Site | Fort Mitchell | Kentucky |
| United States | Research Site | Franklin | Tennessee |
| United States | Research Site | Fresno | California |
| 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 | Georgia |
| United States | Research Site | Gainesville | Florida |
| 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 | Guntersville | Alabama |
| United States | Research Site | Hamden | Connecticut |
| 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 | Hodges | South Carolina |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Huntersville | North Carolina |
| United States | Research Site | Huntington Beach | California |
| United States | Research Site | Jasper | Alabama |
| United States | Research Site | Johnson City | Tennessee |
| United States | Research Site | Kerrville | Texas |
| United States | Research Site | Killeen | Texas |
| 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 | 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 | Michigan City | Indiana |
| 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 | Morgantown | West Virginia |
| United States | Research Site | Mount Pleasant | South Carolina |
| United States | Research Site | Murray | Utah |
| United States | Research Site | Myrtle Beach | South Carolina |
| 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 | North Hollywood | California |
| United States | Research Site | Northridge | California |
| United States | Research Site | O'Fallon | Illinois |
| United States | Research Site | Ocala | Florida |
| United States | Research Site | Ocean City | New Jersey |
| United States | Research Site | Ocoee | Florida |
| United States | Research Site | Oklahoma City | Oklahoma |
| 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 | 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 | Rochester | Michigan |
| 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 | Sacramento | California |
| United States | Research Site | Saint Charles | Missouri |
| 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 Antonio | Texas |
| United States | Research Site | San Antonio | Texas |
| 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 Diego | California |
| United States | Research Site | San Jose | California |
| United States | Research Site | Savannah | Georgia |
| United States | Research Site | Scottsboro | Alabama |
| United States | Research Site | Sherman | Texas |
| United States | Research Site | Shreveport | Louisiana |
| 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 Valley | Washington |
| United States | Research Site | Stockbridge | Georgia |
| United States | Research Site | Stockton | California |
| 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 | Tomball | Texas |
| United States | Research Site | Toms River | New Jersey |
| United States | Research Site | Troy | Michigan |
| United States | Research Site | Tucson | Arizona |
| United States | Research Site | Tucson | Arizona |
| United States | Research Site | Tulsa | Oklahoma |
| United States | Research Site | Tustin | California |
| United States | Research Site | Union | South Carolina |
| United States | Research Site | Waco | Texas |
| United States | Research Site | Warwick | Rhode Island |
| United States | Research Site | Watertown | New York |
| United States | Research Site | Westminster | California |
| United States | Research Site | Wheat Ridge | Colorado |
| 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 | Woodbury | Minnesota |
| United States | Research Site | Wooster | Ohio |
| United States | Research Site | Wyomissing | Pennsylvania |
| United States | Research Site | Zachary | Louisiana |
| Lead Sponsor | Collaborator |
|---|---|
| Pearl Therapeutics, Inc. |
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) | Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 4 hours (AUC0-4)AUC was normalized for length of follow up (e.g. typically 4 hours). | Week 24 | |
| Secondary | Change From Baseline in Morning Pre-dose Trough FEV1 | Week 24 | ||
| Secondary | Rate of Moderate to Severe Asthma Exacerbations | Rate of moderate to severe Asthma exacerbations (A deterioration of asthma requiring a new or increased dose of ICS for at least 3 days) or severe Asthma exacerbation (Use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days OR a hospitalization or ER visit because of asthma) | over 24 Weeks (timepoints of 4, 12 & 20 weeks) | |
| Secondary | Change From Baseline in ACQ-7 (Asthma Control Questionnaire) | ACQ-7: The ACQ, comprising 7 questions, is completed in the clinic and requires subjects to recall their experiences during the previous week (7 days) prior to the study visit. The ACQ-5 measures 5 symptoms (woken at night by symptoms, wake in the morning with symptoms, limitation of daily activities, shortness of breath, and wheeze); the ACQ-6 is these symptom measurements plus daily rescue medication use as recalled by the subject; and the ACQ 7 is the ACQ 6 plus airway caliber as measured by pre-bronchodilator FEV1 percent predicted. Each question is scored on a 7-point scale (generally, 0=no impairment, 6=maximum impairment), the questions are equally weighted, and the ACQ score is the mean of the item responses and therefore ranges from 0 (totally controlled) to 6 (severely uncontrolled. | Week 24 | |
| Secondary | Change From Baseline in ACQ-5 (Asthma Control Questionnaire) | ACQ-5:The ACQ-5 measures 5 symptoms (woken at night by symptoms, wake in the morning with symptoms, limitation of daily activities, shortness of breath, and wheeze). Each question is scored on a 7-point scale (generally, 0=no impairment, 6=maximum impairment), the questions are equally weighted, and the ACQ score is the mean of the item responses and therefore ranges from 0 (totally controlled) to 6 (severely uncontrolled). | Week 24 | |
| Secondary | Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) | AQLQ +12 - Asthma Quality of Life Questionnaire The AQLQ +12 is a 32-item validated subject-administered questionnaire that was developed to measure the functional problems (physical, emotional, social and occupational) that are most troublesome to adults (=18 years of age) and adolescents (12 to 17 years of age) with asthma. The 32 questions in the AQLQ +12 are in 4 domains (symptoms, activity limitation, emotional function, and environmental stimuli). All 4 domains contain standard specific questions relating to each domain. Subjects are asked to think about how they have been during the previous 2 weeks. Responses to each of the 32 questions are on a 7-point scale (7=no impairment to 1=severe impairment). The overall AQLQ +12 score is the mean of all 32 responses. Overall scores range from 1=severe impairment to 7=no impairment. | Week 24 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04624425 -
Additional Effects of Segmental Breathing In Asthma
|
N/A | |
| Terminated |
NCT04410523 -
Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma
|
Phase 2 | |
| Active, not recruiting |
NCT03927820 -
A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
|
||
| Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
| Recruiting |
NCT03694158 -
Investigating Dupilumab's Effect in Asthma by Genotype
|
Phase 4 | |
| Terminated |
NCT04946318 -
Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma
|
Phase 2 | |
| Completed |
NCT04450108 -
Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients
|
N/A | |
| Completed |
NCT03086460 -
A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH)
|
Phase 2 | |
| Completed |
NCT01160224 -
Oral GW766944 (Oral CCR3 Antagonist)
|
Phase 2 | |
| Completed |
NCT03186209 -
Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)
|
Phase 3 | |
| Completed |
NCT02502734 -
Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma
|
Phase 3 | |
| Completed |
NCT01715844 -
L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics
|
Phase 1 | |
| Terminated |
NCT04993443 -
First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036
|
Phase 1 | |
| Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
| Recruiting |
NCT06033833 -
Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study
|
Phase 2 | |
| Completed |
NCT03257995 -
Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.
|
Phase 2 | |
| Completed |
NCT02212483 -
Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients
|
N/A | |
| Recruiting |
NCT04872309 -
MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
|
||
| Withdrawn |
NCT01468805 -
Childhood Asthma Reduction Study
|
N/A | |
| Recruiting |
NCT05145894 -
Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
|