AsthmaPhase 2/3NCT03358147

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

A Phase 2/3 study testing GP MDI 28.8 μg, GP MDI 14.4 μg and GP MDI 7.2 μg in people with Asthma, run by Pearl Therapeutics, Inc. at 232 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 12 to 80 years
Conditions the study is for: Asthma
What is being tested?: GP MDI 28.8 μg, GP MDI 14.4 μg and GP MDI 7.2 μg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,077 participants
Where: 232 sitesUnited States
Study dates: 13 Dec 2017to 12 Sep 2019
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 80 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

232 sites in 1 country.

City, postcode or hospital

232 sites in 1 country

United States232 sites

Research Site
Abingdon, Virginia, 24210
Research Site
Adairsville, Georgia, 30103
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Albany, Georgia, 31707
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Albuquerque, New Mexico, 87108
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Albuquerque, New Mexico, 87109
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Amarillo, Texas, 79106
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Anaheim, California, 92801
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Anderson, South Carolina, 29621
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Ann Arbor, Michigan, 48106
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Atlanta, Georgia, 30345
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Austin, Texas, 78759
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Aventura, Florida, 33180
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Bakersfield, California, 93301
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Bangor, Maine, 04401
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Bellevue, Nebraska, 68005
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Bellevue, Nebraska, 68123
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Bellingham, Washington, 98225
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Berlin, New Jersey, 08009
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Birmingham, Alabama, 35209
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Birmingham, Alabama, 35243
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Boerne, Texas, 78006
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Boise, Idaho, 83706
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Brandon, Florida, 33511
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Brownsburg, Indiana, 46112
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Burlington, North Carolina, 27215
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Carrollton, Texas, 75007
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Centennial, Colorado, 80112
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Chandler, Arizona, 85224
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Charleston, South Carolina, 29406
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Charlotte, North Carolina, 28207
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Charlotte, North Carolina, 28277
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Chesterfield, Missouri, 63017
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Chevy Chase, Maryland, 20815
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Cincinnati, Ohio, 45219
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Cincinnati, Ohio, 45231
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Cincinnati, Ohio, 45242
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Clackamas, Oregon, 97015-5737
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Clearwater, Florida, 33756
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Clearwater, Florida, 33765
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Colorado Springs, Colorado, 80907
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Colorado Springs, Colorado, 80910
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Columbia, Missouri, 65203
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Columbus, Georgia, 31904
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Columbus, Ohio, 43207
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Corona, California, 92879
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Cortland, New York, 13045
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Costa Mesa, California, 92627
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Crowley, Louisiana, 70526
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Dacula, Georgia, 30019
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Dallas, Texas, 75231
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Dallas, Texas, 75235
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Dayton, Ohio, 45419
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Dayton, Ohio, 45459
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Dothan, Alabama, 36303
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Dublin, Ohio, 43016
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East Providence, Rhode Island, 02914
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Edina, Minnesota, 55435
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Edmond, Oklahoma, 73034
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El Cajon, California, 92020
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El Paso, Texas, 79903
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Elizabeth City, North Carolina, 27909
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Encinitas, California, 92024
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Evergreen Park, Illinois, 60805
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Fall River, Massachusetts, 02721
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Fargo, North Dakota, 58103
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Fargo, North Dakota, 58104
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Farmington Hills, Michigan, 48336
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Flagstaff, Arizona, 86001
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Fort Mitchell, Kentucky, 41017
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Franklin, Tennessee, 37067
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Fresno, California, 93702
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Fridley, Minnesota, 55432
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Fullerton, California, 92835
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Gaffney, South Carolina, 29340
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Gaffney, South Carolina, 29341
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Gainesville, Florida, 32653
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Gainesville, Georgia, 30501
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Gastonia, North Carolina, 28054
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Gold River, California, 95670
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Greenfield, Wisconsin, 53228
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Greensboro, North Carolina, 27408
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Greenville, South Carolina, 29615
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Guntersville, Alabama, 35976
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Hamden, Connecticut, 06517
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Hendersonville, Tennessee, 37075
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Hialeah, Florida, 33012
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Hialeah, Florida, 33013
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Hialeah, Florida, 33016
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Hickory, North Carolina, 28078
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Hodges, South Carolina, 29653
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Houston, Texas, 77058
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Houston, Texas, 77074
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Houston, Texas, 77099
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Huntersville, North Carolina, 28078
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Huntington Beach, California, 92647
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Jasper, Alabama, 35501
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Johnson City, Tennessee, 37601
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Kerrville, Texas, 78028
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Killeen, Texas, 76542
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Kissimmee, Florida, 34741
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Lafayette, Colorado, 80026
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Lake City, Florida, 32055
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Lampasas, Texas, 76550
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Las Vegas, Nevada, 89106
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Las Vegas, Nevada, 89119
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Las Vegas, Nevada, 89146
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Lawrenceville, Georgia, 30046
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Lincoln, Nebraska, 68505
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Little Rock, Arkansas, 72205
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Little Rock, Arkansas, 72209
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Little Rock, Arkansas, 72212
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Live Oak, Texas, 78233
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Long Beach, California, 90036
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Long Beach, California, 90806
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Los Angeles, California, 90017
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Los Angeles, California, 90048
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Loxahatchee Groves, Florida, 33470
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Lufkin, Texas, 75904
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Marion, Ohio, 43302
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Medford, Oregon, 97504
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Meridian, Idaho, 83646
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Miami, Florida, 33126
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Miami, Florida, 33174
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Miami, Florida, 33175
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Miami, Florida, 33176
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Miami, Florida, 33186
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Michigan City, Indiana, 46360
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Minneapolis, Minnesota, 55402
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Minneapolis, Minnesota, 55407
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Mission Viejo, California, 92691
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Monroe, North Carolina, 28112
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Monroeville, Pennsylvania, 15665
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Mooresville, North Carolina, 28117
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Morgantown, West Virginia, 26505
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Mt. Pleasant, South Carolina, 29464
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Murray, Utah, 84107
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Myrtle Beach, South Carolina, 29588
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New Bern, North Carolina, 28562
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New York, New York, 10016
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Newport Beach, California, 92663
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Newport News, Virginia, 23606
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Norcross, Georgia, 30071
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North Dartmouth, Massachusetts, 02747
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North Hollywood, California, 91606
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Northridge, California, 91324
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O'Fallon, Illinois, 62269
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Ocala, Florida, 34471
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Ocean City, New Jersey, 07712
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Ocoee, Florida, 34761
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Oklahoma City, Oklahoma, 73131
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Omaha, Nebraska, 68114
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Orange, California, 92868
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Orlando, Florida, 32811
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Palmdale, California, 93551
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Panama City, Florida, 32405
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Pearland, Texas, 77584
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Pembroke Pines, Florida, 33029
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Phoenix, Arizona, 85018
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Pittsburgh, Pennsylvania, 15236
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Pittsburgh, Pennsylvania, 15241
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Plano, Texas, 75093
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Portland, Oregon, 97202
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Poway, California, 92064
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Quartz Hill, California, 93536
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Raleigh, North Carolina, 27612
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Rancho Mirage, California, 92270
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Rapid City, South Dakota, 57702
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Reno, Nevada, 89503
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Richmond, Virginia, 23114
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Richmond, Virginia, 23226
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Rincon, Georgia, 31326
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River Forest, Illinois, 60305
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Riverside, California, 92506
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Rochester, Michigan, 48307
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Rock Hill, South Carolina, 29732
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Rolling Hills Estates, California, 90274
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Sacramento, California, 95821
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Sacramento, California, 95823
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Sacramento, California, 95831
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Saint Charles, Missouri, 63301
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Saint Cloud, Florida, 34769
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Salt Lake City, Utah, 84102
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Salt Lake City, Utah, 84107
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San Antonio, Texas, 78205
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San Antonio, Texas, 78215
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San Antonio, Texas, 78229
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San Antonio, Texas, 78258
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San Diego, California, 92117
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San Diego, California, 92119
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San Diego, California, 92120
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San Diego, California, 92123
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San Jose, California, 95117
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Savannah, Georgia, 31406
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Scottsboro, Alabama, 35768
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Sherman, Texas, 75092
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Shreveport, Louisiana, 71106
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Skillman, New Jersey, 08558
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Smyrna, Tennessee, 37167
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South Burlington, Vermont, 05403
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Spartanburg, South Carolina, 29301
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Spartanburg, South Carolina, 29303
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Spokane Valley, Washington, 99216
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St Louis, Missouri, 63141
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Stockbridge, Georgia, 30281
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Stockton, California, 95207
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Tacoma, Washington, 98405
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Tallahassee, Florida, 32308
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Tampa, Florida, 33603
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Tempe, Arizona, 85283
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The Bronx, New York, 10455
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The Bronx, New York, 10468
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Thousand Oaks, California, 91360
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Tomball, Texas, 77375
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Toms River, New Jersey, 08755
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Troy, Michigan, 48085
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Tucson, Arizona, 85710
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Tucson, Arizona, 85745
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Tulsa, Oklahoma, 74136
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Tustin, California, 92780
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Union, South Carolina, 29379
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Waco, Texas, 76712
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Warwick, Rhode Island, 02886
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Watertown, New York, 13601
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Westminster, California, 92683
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Wheat Ridge, Colorado, 80033
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White Marsh, Maryland, 21162
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Winston-Salem, North Carolina, 27103
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Winter Park, Florida, 32789
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Woodbury, Minnesota, 55125
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Wooster, Ohio, 44691
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Wyomissing, Pennsylvania, 19610
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Zachary, Louisiana, 70791

Other trials in United States

About this study

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

Read the detailed 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

Conditions: Asthma
Being tested: GP MDI 28.8 μg, GP MDI 14.4 μg, GP MDI 7.2 μg, Placebo MDI, Spiriva Respimat 2.5 μg
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GP MDI 28.8 μgDrug
Also called GP
GP MDI (PT001)14.4 μg per actuation taken as 2 inhalations BID
GP MDI 14.4 μgDrug
Also called GP
GP MDI (PT001) 7.2 μg per actuation taken as 2 inhalations BID
GP MDI 7.2 μgDrug
Also called GP
GP MDI (PT001) 3.6 μg per actuation taken as 2 inhalations BID
Placebo MDIDrug
Also called Placebo
Placebo taken as 2 inhalations BID
Spiriva Respimat 2.5 μgDrug
Also called Spiriva Respimat
Spiriva Respimat 2.5 μg QD (open-label)

Study groups in NCT03358147
Study group	Role	What they receive
GP MDI 28.8 μg	Experimental	GP MDI 14.4 μg per actuation taken as 2 inhalations BID Receives: Drug: GP MDI 28.8 μg
GP MDI 14.4 μg	Experimental	GP MDI 7.2 μg per actuation taken as 2 inhalations BID Receives: Drug: GP MDI 14.4 μg
GP MDI 7.2 μg	Experimental	GP MDI 3.6 μg per actuation taken as 2 inhalations BID Receives: Drug: GP MDI 7.2 μg
Placebo MDI	Placebo comparator	Taken as 2 inhalations BID Receives: Drug: Placebo MDI
Spiriva Respimat 2.5 μg	Other	Open Label Spiriva Respimat 2.5 μg Receives: Drug: Spiriva Respimat 2.5 μg

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Week 24

Secondary outcomes (5)

Change From Baseline in Morning Pre-dose Trough FEV1
Measured: Week 24
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)
Measured: over 24 Weeks (timepoints of 4, 12 & 20 weeks)
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.
Measured: Week 24
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).
Measured: Week 24
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.
Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Dec 201712 Sep 2019

First posted30 Nov 2017
Study start13 Dec 2017
Primary completion12 Sep 2019
Study completion12 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Linear repeated measures model
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,077 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03358147
Sponsor's protocol ID: PT001102
Status last verified: Aug 2020
First submitted: 20 Nov 2017
Last updated: 12 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
PubMed 36472162

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03358147
Acronym / sponsor ID: PT001102
Conditions: Asthma
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,077 participants (actual)
Lead sponsor: Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 13 Dec 2017 (actual)
Primary completion: 12 Sep 2019 (actual)
Study completion: 12 Sep 2019 (actual)
First posted: 30 Nov 2017 (actual)
Results: Posted 12 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5
Model description: Linear repeated measures model

Arm	Type	Receives
GP MDI 28.8 μg	Experimental	Drug: GP MDI 28.8 μgGP MDI 14.4 μg per actuation taken as 2 inhalations BID
GP MDI 14.4 μg	Experimental	Drug: GP MDI 14.4 μgGP MDI 7.2 μg per actuation taken as 2 inhalations BID
GP MDI 7.2 μg	Experimental	Drug: GP MDI 7.2 μgGP MDI 3.6 μg per actuation taken as 2 inhalations BID
Placebo MDI	Placebo comparator	Drug: Placebo MDITaken as 2 inhalations BID
Spiriva Respimat 2.5 μg	Other	Drug: Spiriva Respimat 2.5 μgOpen Label Spiriva Respimat 2.5 μg

Who may qualify

Ages: 12 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GP MDI 28.8 μgAlso: GPGP MDI (PT001)14.4 μg per actuation taken as 2 inhalations BID	Drug	GP MDI 28.8 μg
GP MDI 14.4 μgAlso: GPGP MDI (PT001) 7.2 μg per actuation taken as 2 inhalations BID	Drug	GP MDI 14.4 μg
GP MDI 7.2 μgAlso: GPGP MDI (PT001) 3.6 μg per actuation taken as 2 inhalations BID	Drug	GP MDI 7.2 μg
Placebo MDIAlso: PlaceboPlacebo taken as 2 inhalations BID	Drug	Placebo MDI
Spiriva Respimat 2.5 μgAlso: Spiriva RespimatSpiriva Respimat 2.5 μg QD (open-label)	Drug	Spiriva Respimat 2.5 μg

Primary outcome

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0 to 4 Hours (AUC0-4)
Time frame: Week 24
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).

5 secondary outcomes

Change From Baseline in Morning Pre-dose Trough FEV1
Time frame: Week 24
Rate of Moderate to Severe Asthma Exacerbations
Time frame: over 24 Weeks (timepoints of 4, 12 & 20 weeks)
Change From Baseline in ACQ-7 (Asthma Control Questionnaire)
Time frame: Week 24
Change From Baseline in ACQ-5 (Asthma Control Questionnaire)
Time frame: Week 24
Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12)
Time frame: Week 24

Results and safety

Results posted to the registry on 12 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GP MDI 28.8 μg	235	201
GP MDI 14.4 μg	240	201
GP MDI 7.2 μg	240	206
Placebo MDI	237	201
Spiriva Respimat 2.5 μg	119	105

Primary outcome: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0 to 4 Hours (AUC0-4)

Time frame: Week 24. Least squares mean (95% Confidence Interval). Unit: Liter

Measure	GP MDI 28.8 μg n = 195	GP MDI 14.4 μg n = 199	GP MDI 7.2 μg n = 205	Placebo MDI n = 196	Spiriva Respimat 2.5 μg n = 103
Value	0.294 (0.248 to 0.341)	0.284 (0.238 to 0.331)	0.308 (0.263 to 0.354)	0.240 (0.194 to 0.287)	0.347 (0.282 to 0.412)

Population analysed: mITT Population

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call up to approximately 30 weeks. Adverse Events were collected from the time subject was randomized up to approximately 26 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GP MDI 28.8 μg	9 of 235 (3.8%)	33 of 235 (14%)	0 of 235
GP MDI 14.4 μg	7 of 240 (2.9%)	35 of 240 (14.6%)	0 of 240
GP MDI 7.2 μg	6 of 240 (2.5%)	33 of 240 (13.8%)	0 of 240
Placebo MDI	7 of 237 (3%)	29 of 237 (12.2%)	0 of 237
Spiriva Respimat 2.5 μg	2 of 119 (1.7%)	14 of 119 (11.8%)	0 of 119

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36472162Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

232 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing GP MDI 28.8 μg, GP MDI 14.4 μg and GP MDI 7.2 μg in people with Asthma, run by Pearl Therapeutics, Inc. at 232 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 232 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0 to 4 Hours (AUC0-4) (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03358147, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.