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



Status:Active, not recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - 80
Updated:4/6/2019
Start Date:December 13, 2017
End Date:September 27, 2019

Use our guide to learn which trials are right for you!

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

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

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
We found this trial at
202
sites
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Abingdon, VA
Click here to add this to my saved trials
?
mi
from
Adairsville, GA
Click here to add this to my saved trials
?
mi
from
Albany, GA
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Amarillo, TX
Click here to add this to my saved trials
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
?
mi
from
Anderson, SC
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Aventura, FL
Click here to add this to my saved trials
?
mi
from
Baker, LA
Click here to add this to my saved trials
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Bangor, ME
Click here to add this to my saved trials
?
mi
from
Beaumont, TX
Click here to add this to my saved trials
?
mi
from
Bellevue, NE
Click here to add this to my saved trials
?
mi
from
Bellingham, WA
Click here to add this to my saved trials
?
mi
from
Berlin, NJ
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Boerne, TX
Click here to add this to my saved trials
?
mi
from
Brandon, FL
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Brownsburg, IN
Click here to add this to my saved trials
Burlington, North Carolina 27215
?
mi
from
Burlington, NC
Click here to add this to my saved trials
?
mi
from
Carrollton, TX
Click here to add this to my saved trials
?
mi
from
Centennial, CO
Click here to add this to my saved trials
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
Charleston, South Carolina 29412
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
?
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Clackamas, OR
Click here to add this to my saved trials
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
?
mi
from
Columbia, MO
Click here to add this to my saved trials
?
mi
from
Columbus, GA
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Corona, CA
Click here to add this to my saved trials
?
mi
from
Cortland, NY
Click here to add this to my saved trials
?
mi
from
Costa Mesa, CA
Click here to add this to my saved trials
?
mi
from
Crowley, LA
Click here to add this to my saved trials
123 Broad Street
Dacula, Georgia 30019
?
mi
from
Dacula, GA
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
?
mi
from
Dothan, AL
Click here to add this to my saved trials
?
mi
from
Easley, SC
Click here to add this to my saved trials
East Providence, Rhode Island 02915
?
mi
from
East Providence, RI
Click here to add this to my saved trials
?
mi
from
Edina, MN
Click here to add this to my saved trials
?
mi
from
Edmond, OK
Click here to add this to my saved trials
?
mi
from
El Cajon, CA
Click here to add this to my saved trials
?
mi
from
El Paso, TX
Click here to add this to my saved trials
Elizabeth City, North Carolina 27909
?
mi
from
Elizabeth City, NC
Click here to add this to my saved trials
?
mi
from
Encinitas, CA
Click here to add this to my saved trials
?
mi
from
Evergreen Park, IL
Click here to add this to my saved trials
Fall River, Massachusetts 02720
?
mi
from
Fall River, MA
Click here to add this to my saved trials
?
mi
from
Fargo, ND
Click here to add this to my saved trials
Farmington Hills, Michigan 48334
?
mi
from
Farmington Hills, MI
Click here to add this to my saved trials
?
mi
from
Flagstaff, AZ
Click here to add this to my saved trials
?
mi
from
Fort Mitchell, KY
Click here to add this to my saved trials
?
mi
from
Franklin, TN
Click here to add this to my saved trials
?
mi
from
Fresno, CA
Click here to add this to my saved trials
?
mi
from
Fridley, MN
Click here to add this to my saved trials
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
?
mi
from
Gaffney, SC
Click here to add this to my saved trials
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
?
mi
from
Gainesville, GA
Click here to add this to my saved trials
?
mi
from
Gastonia, NC
Click here to add this to my saved trials
?
mi
from
Gold River, CA
Click here to add this to my saved trials
?
mi
from
Greenfield, WI
Click here to add this to my saved trials
Greensboro, North Carolina 27401
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Greenville, South Carolina 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
?
mi
from
Grove City, OH
Click here to add this to my saved trials
?
mi
from
Guntersville, AL
Click here to add this to my saved trials
?
mi
from
Hamden, CT
Click here to add this to my saved trials
?
mi
from
Hendersonville, TN
Click here to add this to my saved trials
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
Hickory, NC
Click here to add this to my saved trials
Highland Park, New Jersey 08904
?
mi
from
Highland Park, NJ
Click here to add this to my saved trials
?
mi
from
Hodges, SC
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntersville, North Carolina 28078
?
mi
from
Huntersville, NC
Click here to add this to my saved trials
Huntington Beach, California 92646
?
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
?
mi
from
Jasper, AL
Click here to add this to my saved trials
?
mi
from
Johnson City, TN
Click here to add this to my saved trials
?
mi
from
Kerrville, TX
Click here to add this to my saved trials
?
mi
from
Killeen, TX
Click here to add this to my saved trials
?
mi
from
Kingsport, TN
Click here to add this to my saved trials
?
mi
from
Kissimmee, FL
Click here to add this to my saved trials
?
mi
from
Lafayette, CO
Click here to add this to my saved trials
?
mi
from
Lake City, FL
Click here to add this to my saved trials
?
mi
from
Lampasas, TX
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Lawrenceville, GA
Click here to add this to my saved trials
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Live Oak, TX
Click here to add this to my saved trials
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials