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

Last updated: N/A
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

2/3

Condition

Asthma

Treatment

N/A

Clinical Study ID

NCT03547466
PT001102
  • Ages 12-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a documented history of physician-diagnosed asthma

  • Require inhaled asthma maintenance therapy: has been regularly using an ICS/LABA forat 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 asthmatherapy, as required by the protocol

  • Compliance: must be willing to remain at the study center as required per protocol tocomplete all visit assessments

Exclusion

Exclusion Criteria:

  • Oral corticosteroid use (any dose) within 14 days

  • Current smokers, former smokers with >10 pack-years history, or former smokers whostopped smoking <6 months (including all forms of tobacco, e-cigarettes, andmarijuana)

  • Life-threatening asthma as defined as a history of significant asthma episode(s)requiring intubation associated with hypercapnia, respiratory arrest, hypoxicseizures, or asthma-related syncopal episode(s)

  • Completed treatment for lower respiratory infection or asthma exacerbation within 4weeks

  • 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 withinthe last 30 days or 5 half-lives, whichever is longer

  • Previously randomized in any PT001 study

Study Design

Total Participants: 1125
Study Start date:
December 13, 2017
Estimated Completion Date:
July 01, 2019

Study Description

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

Connect with a study center

  • Research Site

    Waterbury, Connecticut 06708
    United States

    Site Not Available

    25.14 miles

  • Research Site

    Hamden, Connecticut 06517
    United States

    Active - Recruiting

    31.09 miles

  • Research Site

    Warwick, Rhode Island 02886
    United States

    Active - Recruiting

    62.78 miles

  • Research Site

    North Dartmouth, Massachusetts 02747
    United States

    Active - Recruiting

    86.03 miles

  • Research Site

    Bronx, New York 10468
    United States

    Active - Recruiting

    88.75 miles

  • Research Site

    New York, New York 10016
    United States

    Site Not Available

    97.68 miles

  • Research Site

    Highland Park, New Jersey 08904
    United States

    Site Not Available

    126.29 miles

  • Research Site

    Ocean City, New Jersey 07712
    United States

    Site Not Available

    127.09 miles

  • Research Site

    Skillman, New Jersey 08558
    United States

    Active - Recruiting

    140.9 miles

  • Research Site

    Toms River, New Jersey 08755
    United States

    Site Not Available

    145.76 miles

  • Research Site

    Berlin, New Jersey 08009
    United States

    Active - Recruiting

    181.94 miles

  • Research Site

    South Burlington, Vermont 05403
    United States

    Active - Recruiting

    187.08 miles

  • Research Site

    White Marsh, Maryland 21162
    United States

    Active - Recruiting

    255.19 miles

  • Research Site

    Baltimore, Maryland 21236
    United States

    Active - Recruiting

    258.71 miles

  • Research Site

    Bangor, Maine 04401
    United States

    Active - Recruiting

    287.0 miles

  • Research Site

    Chevy Chase, Maryland 20815
    United States

    Active - Recruiting

    300.99 miles

  • Research Site

    Monroeville, Pennsylvania 15665
    United States

    Active - Recruiting

    377.1 miles

  • Research Site

    Newport News, Virginia 23606
    United States

    Active - Recruiting

    382.51 miles

  • Research Site

    Virginia Beach, Virginia 23454
    United States

    Site Not Available

    384.91 miles

  • Research Site

    Richmond, Virginia 23235
    United States

    Active - Recruiting

    392.22 miles

  • Research Site

    Pittsburgh, Pennsylvania 15236
    United States

    Active - Recruiting

    392.7 miles

  • Research Site

    New Bern, North Carolina 28562
    United States

    Active - Recruiting

    520.59 miles

  • Research Site

    Raleigh, North Carolina 27612
    United States

    Active - Recruiting

    521.54 miles

  • Research Site

    Greensboro, North Carolina 27405
    United States

    Site Not Available

    544.0 miles

  • Research Site

    Farmington Hills, Michigan 48336
    United States

    Active - Recruiting

    548.83 miles

  • Research Site

    Marion, Ohio 43302
    United States

    Site Not Available

    549.24 miles

  • Research Site

    Columbus, Ohio 43207
    United States

    Active - Recruiting

    552.82 miles

  • Research Site

    Grove City, Ohio 43123
    United States

    Active - Recruiting

    561.34 miles

  • Research Site

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

    569.12 miles

  • Research Site

    Mooresville, North Carolina 28117
    United States

    Site Not Available

    615.58 miles

  • Research Site

    Dayton, Ohio 45459
    United States

    Active - Recruiting

    618.94 miles

  • Research Site

    Huntersville, North Carolina 28078
    United States

    Active - Recruiting

    622.92 miles

  • Research Site

    Hickory, North Carolina 28078
    United States

    Active - Recruiting

    622.92 miles

  • Research Site

    Charlotte, North Carolina 28207
    United States

    Active - Recruiting

    632.16 miles

  • Research Site

    Monroe, North Carolina 28112
    United States

    Active - Recruiting

    637.48 miles

  • Research Site

    Gastonia, North Carolina 28054
    United States

    Site Not Available

    641.12 miles

  • Research Site

    Kingsport, Tennessee 37660
    United States

    Site Not Available

    641.31 miles

  • Research Site

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

    647.94 miles

  • Research Site

    Fort Mitchell, Kentucky 41017
    United States

    Site Not Available

    652.79 miles

  • Research Site

    Rock Hill, South Carolina 29732
    United States

    Site Not Available

    653.32 miles

  • Research Site

    Gaffney, South Carolina 29340
    United States

    Active - Recruiting

    672.32 miles

  • Research Site

    Asheville, North Carolina 28801
    United States

    Site Not Available

    681.76 miles

  • Research Site

    Union, South Carolina 29379
    United States

    Active - Recruiting

    687.67 miles

  • Research Site

    Spartanburg, South Carolina 29301
    United States

    Active - Recruiting

    691.05 miles

  • Research Site

    Greenville, South Carolina 29615
    United States

    Active - Recruiting

    706.16 miles

  • Research Site

    Easley, South Carolina 29640
    United States

    Site Not Available

    715.95 miles

  • Research Site

    Brownsburg, Indiana 46112
    United States

    Active - Recruiting

    727.86 miles

  • Research Site

    Charleston, South Carolina 29406
    United States

    Active - Recruiting

    731.06 miles

  • Research Site

    Mount Pleasant, South Carolina 29464
    United States

    Active - Recruiting

    732.56 miles

  • Research Site

    Anderson, South Carolina 29621
    United States

    Active - Recruiting

    735.67 miles

  • Research Site

    Seneca, South Carolina 29678
    United States

    Active - Recruiting

    742.9 miles

  • Research Site

    River Forest, Illinois 60305
    United States

    Active - Recruiting

    778.75 miles

  • Research Site

    West Allis, Wisconsin 53227
    United States

    Site Not Available

    787.85 miles

  • Research Site

    Greenfield, Wisconsin 53228
    United States

    Active - Recruiting

    787.85 miles

  • Research Site

    Rincon, Georgia 31326
    United States

    Active - Recruiting

    805.56 miles

  • Research Site

    Dacula, Georgia 30019
    United States

    Active - Recruiting

    813.09 miles

  • Research Site

    Lawrenceville, Georgia 30046
    United States

    Active - Recruiting

    818.93 miles

  • Research Site

    Duluth, Georgia 30096
    United States

    Site Not Available

    823.93 miles

  • Research Site

    Norcross, Georgia 30071
    United States

    Active - Recruiting

    828.09 miles

  • Research Site

    Hendersonville, Tennessee 37075
    United States

    Site Not Available

    834.86 miles

  • Research Site

    Atlanta, Georgia 30345
    United States

    Active - Recruiting

    835.56 miles

  • Research Site

    Smyrna, Tennessee 37167
    United States

    Site Not Available

    844.81 miles

  • Research Site

    Franklin, Tennessee 37067
    United States

    Active - Recruiting

    858.25 miles

  • Research Site

    Guntersville, Alabama 35976
    United States

    Active - Recruiting

    900.65 miles

  • Research Site

    Albany, Georgia 31707
    United States

    Active - Recruiting

    948.36 miles

  • Research Site

    Saint Louis, Missouri 63141
    United States

    Active - Recruiting

    960.72 miles

  • Research Site

    Birmingham, Alabama 35209
    United States

    Site Not Available

    960.89 miles

  • Research Site

    Chesterfield, Missouri 63017
    United States

    Active - Recruiting

    964.85 miles

  • Research Site

    Lake City, Florida 32055
    United States

    Active - Recruiting

    967.91 miles

  • Research Site

    Gainesville, Florida 32653
    United States

    Active - Recruiting

    992.07 miles

  • Research Site

    Tallahassee, Florida 32308
    United States

    Active - Recruiting

    1,009.55 miles

  • Research Site

    Ocala, Florida 34471
    United States

    Site Not Available

    1,018.9 miles

  • Research Site

    Winter Park, Florida 32789
    United States

    Site Not Available

    1,031.78 miles

  • Research Site

    Ocoee, Florida 34761
    United States

    Site Not Available

    1,037.86 miles

  • Research Site

    Woodbury, Minnesota 55125
    United States

    Active - Recruiting

    1,038.66 miles

  • Research Site

    Orlando, Florida 32811
    United States

    Active - Recruiting

    1,039.43 miles

  • Research Site

    Kissimmee, Florida 34741
    United States

    Site Not Available

    1,052.03 miles

  • Research Site

    Saint Cloud, Florida 34769
    United States

    Site Not Available

    1,052.45 miles

  • Research Site

    Fridley, Minnesota 55432
    United States

    Active - Recruiting

    1,054.88 miles

  • Research Site

    Minneapolis, Minnesota 55402
    United States

    Active - Recruiting

    1,054.94 miles

  • Research Site

    Columbia, Missouri 65203
    United States

    Active - Recruiting

    1,055.2 miles

  • Research Site

    Edina, Minnesota 55435
    United States

    Active - Recruiting

    1,057.46 miles

  • Research Site

    Plymouth, Minnesota 55441
    United States

    Site Not Available

    1,062.76 miles

  • Research Site

    Panama City, Florida 32405
    United States

    Active - Recruiting

    1,077.36 miles

  • Research Site

    Brandon, Florida 33511
    United States

    Active - Recruiting

    1,099.99 miles

  • Research Site

    Tampa, Florida 33603
    United States

    Active - Recruiting

    1,100.13 miles

  • Research Site

    Clearwater, Florida 33765
    United States

    Active - Recruiting

    1,108.76 miles

  • Research Site

    Loxahatchee Groves, Florida 33470
    United States

    Site Not Available

    1,123.43 miles

  • Research Site

    Little Rock, Arkansas 72212
    United States

    Site Not Available

    1,170.65 miles

  • Research Site

    Aventura, Florida 33180
    United States

    Active - Recruiting

    1,171.63 miles

  • Research Site

    Pembroke Pines, Florida 33029
    United States

    Active - Recruiting

    1,175.24 miles

  • Research Site

    Hialeah, Florida 33012
    United States

    Active - Recruiting

    1,181.2 miles

  • Research Site

    Miami, Florida 33174
    United States

    Active - Recruiting

    1,189.17 miles

  • Research Site

    Bellevue, Nebraska 68005
    United States

    Active - Recruiting

    1,199.52 miles

  • Research Site

    Omaha, Nebraska 68114
    United States

    Active - Recruiting

    1,206.22 miles

  • Research Site

    Dakota Dunes, South Dakota 57049
    United States

    Site Not Available

    1,218.02 miles

  • Research Site

    Fargo, North Dakota 58104
    United States

    Active - Recruiting

    1,239.18 miles

  • Research Site

    Lincoln, Nebraska 68505
    United States

    Active - Recruiting

    1,240.48 miles

  • Research Site

    Tulsa, Oklahoma 74136
    United States

    Active - Recruiting

    1,306.71 miles

  • Research Site

    Sunset, Louisiana 70584
    United States

    Site Not Available

    1,334.4 miles

  • Research Site

    Crowley, Louisiana 70526
    United States

    Active - Recruiting

    1,354.96 miles

  • Research Site

    Edmond, Oklahoma 73034
    United States

    Active - Recruiting

    1,392.68 miles

  • Research Site

    Lufkin, Texas 75904
    United States

    Active - Recruiting

    1,419.07 miles

  • Research Site

    Sherman, Texas 75092
    United States

    Active - Recruiting

    1,421.79 miles

  • Research Site

    Beaumont, Texas 77702
    United States

    Site Not Available

    1,439.79 miles

  • Research Site

    Allen, Texas 75013
    United States

    Site Not Available

    1,440.41 miles

  • Research Site

    Plano, Texas 75093
    United States

    Active - Recruiting

    1,448.97 miles

  • Research Site

    Dallas, Texas 75231
    United States

    Active - Recruiting

    1,451.78 miles

  • Research Site

    Pearland, Texas 77584
    United States

    Site Not Available

    1,519.93 miles

  • Research Site

    Houston, Texas 77074
    United States

    Active - Recruiting

    1,521.34 miles

  • Research Site

    Waco, Texas 76712
    United States

    Active - Recruiting

    1,527.71 miles

  • Research Site

    Rapid City, South Dakota 57702
    United States

    Site Not Available

    1,553.17 miles

  • Research Site

    Killeen, Texas 76542
    United States

    Active - Recruiting

    1,571.27 miles

  • Research Site

    Lampasas, Texas 76550
    United States

    Active - Recruiting

    1,592.21 miles

  • Research Site

    Live Oak, Texas 78233
    United States

    Active - Recruiting

    1,661.03 miles

  • Research Site

    Boerne, Texas 78006
    United States

    Active - Recruiting

    1,664.74 miles

  • Research Site

    San Antonio, Texas 78229
    United States

    Active - Recruiting

    1,673.09 miles

  • Research Site

    Kerrville, Texas 78028
    United States

    Active - Recruiting

    1,679.32 miles

  • Research Site

    Centennial, Colorado 80112
    United States

    Site Not Available

    1,683.52 miles

  • Research Site

    Lafayette, Colorado 80026
    United States

    Active - Recruiting

    1,687.87 miles

  • Research Site

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

    1,695.13 miles

  • Research Site

    Albuquerque, New Mexico 87108
    United States

    Active - Recruiting

    1,879.47 miles

  • Research Site

    El Paso, Texas 79903
    United States

    Active - Recruiting

    1,976.56 miles

  • Research Site

    Murray, Utah 84107
    United States

    Active - Recruiting

    2,021.65 miles

  • Research Site

    Salt Lake City, Utah 84107
    United States

    Site Not Available

    2,021.65 miles

  • Research Site

    Spokane Valley, Washington 99216
    United States

    Active - Recruiting

    2,192.78 miles

  • Research Site

    Tucson, Arizona 85745
    United States

    Active - Recruiting

    2,197.21 miles

  • Research Site

    Meridian, Idaho 83646
    United States

    Active - Recruiting

    2,199.56 miles

  • Research Site

    Spokane, Washington 99202
    United States

    Site Not Available

    2,200.84 miles

  • Research Site

    Phoenix, Arizona 85018
    United States

    Active - Recruiting

    2,204.54 miles

  • Research Site

    Chandler, Arizona 85224
    United States

    Active - Recruiting

    2,204.61 miles

  • Research Site

    Tempe, Arizona 85283
    United States

    Active - Recruiting

    2,206.2 miles

  • Research Site

    Las Vegas, Nevada 89119
    United States

    Active - Recruiting

    2,292.65 miles

  • Research Site

    Rancho Mirage, California 92270
    United States

    Active - Recruiting

    2,425.5 miles

  • Research Site

    Tacoma, Washington 98405
    United States

    Site Not Available

    2,440.41 miles

  • Research Site

    Reno, Nevada 89503
    United States

    Active - Recruiting

    2,445.91 miles

  • Research Site

    Riverside, California 92506
    United States

    Active - Recruiting

    2,468.7 miles

  • Research Site

    Portland, Oregon 97202
    United States

    Active - Recruiting

    2,471.85 miles

  • Research Site

    Corona, California 92879
    United States

    Active - Recruiting

    2,479.07 miles

  • Research Site

    Poway, California 92064
    United States

    Active - Recruiting

    2,480.28 miles

  • Research Site

    Palmdale, California 93551
    United States

    Active - Recruiting

    2,493.19 miles

  • Research Site

    Mission Viejo, California 92691
    United States

    Active - Recruiting

    2,494.04 miles

  • Research Site

    San Diego, California 92117
    United States

    Active - Recruiting

    2,494.6 miles

  • Research Site

    Quartz Hill, California 93536
    United States

    Active - Recruiting

    2,496.88 miles

  • Research Site

    Fullerton, California 92835
    United States

    Active - Recruiting

    2,497.94 miles

  • Research Site

    Orange, California 92868
    United States

    Active - Recruiting

    2,499.41 miles

  • Research Site

    Anaheim, California 92801
    United States

    Active - Recruiting

    2,501.57 miles

  • Research Site

    Costa Mesa, California 92627
    United States

    Active - Recruiting

    2,505.98 miles

  • Research Site

    Westminster, California 92683
    United States

    Active - Recruiting

    2,506.54 miles

  • Research Site

    Newport Beach, California 92663
    United States

    Active - Recruiting

    2,507.24 miles

  • Research Site

    Huntington Beach, California 92647
    United States

    Active - Recruiting

    2,508.09 miles

  • Research Site

    Bakersfield, California 93301
    United States

    Active - Recruiting

    2,511.03 miles

  • Research Site

    Long Beach, California 90036
    United States

    Active - Recruiting

    2,515.2 miles

  • Research Site

    Los Angeles, California 90048
    United States

    Active - Recruiting

    2,516.29 miles

  • Research Site

    Rolling Hills Estates, California 90274
    United States

    Site Not Available

    2,525.07 miles

  • Research Site

    Medford, Oregon 97504
    United States

    Active - Recruiting

    2,533.9 miles

  • Research Site

    Thousand Oaks, California 91360
    United States

    Site Not Available

    2,537.97 miles

  • Research Site

    Gold River, California 95670
    United States

    Active - Recruiting

    2,540.62 miles

  • Research Site

    Sacramento, California 95823
    United States

    Active - Recruiting

    2,552.06 miles

  • Research Site

    Stockton, California 95207
    United States

    Site Not Available

    2,557.96 miles

  • Research Site

    San Jose, California 95117
    United States

    Active - Recruiting

    2,608.24 miles

  • Research Site

    Clackamas, Oregon 97015-5737
    United States

    Active - Recruiting

  • Research Site

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

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