Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma
Start Date
5/20/2024
Completion Date
10/13/2027
Summary
The purpose of this study is to compare the effect of budesonide/albuterol metered-dose inhaler (BDA MDI) with albuterol sulfate metered-dose inhaler (AS MDI), both administered as needed, on the annualized rate of severe asthma exacerbations in adolescents with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year.
Detailed Description
This is a randomized, double-blind, multicenter, parallel-group Phase IIIb study with a fixed treatment period of 52 weeks. The study will consist of 3 periods: 1. Screening period (7 to 28 days) 2. Treatment period of 52 weeks 3. Safety follow-up period (7 to 14 days after the end of treatment \[EOT\] visit) Participants who meet the eligibility criteria will be randomly assigned to BDA MDI 160/180 micrograms (μg) or AS MDI 180 μg treatment groups in a 1:1 ratio on top of their own usual maintenance therapy during treatment period. This study will also include a pharmacokinetic (PK) sub-study with single visit scheduled after the safety follow-up visit in the main study. During PK sub-study, single dose of open-label BDA MDI 160/180 μg will be administered.
Eligibility Criteria
Age Range: 12 years to 17 years
Interventions
BDA MDI
AS MDI
Conditions
Locations
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Anchorage, Alaska 99508
United States
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Gilbert, Arizona 85234
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Phoenix, Arizona 85016
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Little Rock, Arkansas 72202
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Huntington Beach, California 92647
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Huntington Beach, California 92648
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Long Beach, California 90806
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Long Beach, California 90815
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Madera, California 93636
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Mission Viejo, California 92691
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Moreno Valley, California 92553
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Orange, California 92868
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Redondo Beach, California 90277
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Riverside, California 92506
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San Diego, California 92123
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San Diego, California 92123
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San Francisco, California 94143
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Westminster, California 92683
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Denver, Colorado 80206
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Wilmington, Delaware 19803
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Destin, Florida 32541
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Jacksonville, Florida 32207
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Kendall, Florida 33176
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Largo, Florida 33777
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Miami, Florida 33145
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Pembroke Pines, Florida 33026
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Tampa, Florida 33613
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Atlanta, Georgia 30329
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Columbus, Georgia 31904
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Fayetteville, Georgia 30214
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Snellville, Georgia 30078
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Meridian, Idaho 83646
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Normal, Illinois 61761
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River Forest, Illinois 60305
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Indianapolis, Indiana 46202
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Kansas City, Kansas 66160
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Louisville, Kentucky 40202
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Louisville, Kentucky 40217
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Lafayette, Louisiana 70508
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New Orleans, Louisiana 70121
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New Orleans, Louisiana 70125
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Ellicott City, Maryland 21043
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Lanham, Maryland 20706
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Silver Spring, Maryland 20902
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White Marsh, Maryland 21162
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Boston, Massachusetts 02114
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Detroit, Michigan 48201
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Mankato, Minnesota 56001
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Kansas City, Missouri 64108
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Kansas City, Missouri 64118
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Missoula, Montana 59804
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Lincoln, Nebraska 68510
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Lincoln, Nebraska 68516
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Omaha, Nebraska 68114
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Newark, New Jersey 07103
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Northfield, New Jersey 08225
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Ocean City, New Jersey 07712
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Paramus, New Jersey 07652
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Albuquerque, New Mexico 87106
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Albany, New York 12208
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Cortland, New York 13045
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Hawthorne, New York 10532
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Hollis, New York 11423
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New York, New York 10019
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New York, New York 10032
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Rochester, New York 14607
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The Bronx, New York 10459
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The Bronx, New York 10461
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Vestal, New York 13850
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Vestal, New York 13850
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Watertown, New York 13601
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Charlotte, North Carolina 28277
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Cincinnati, Ohio 45229
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Columbus, Ohio 43205
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Columbus, Ohio 43228
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Dayton, Ohio 45424
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Findlay, Ohio 45840
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Toledo, Ohio 43617
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Oklahoma City, Oklahoma 73104
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Oklahoma City, Oklahoma 73120
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Yukon, Oklahoma 73099
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Pittsburgh, Pennsylvania 15241
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Charleston, South Carolina 29425
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Rock Hill, South Carolina 29730
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Sioux Falls, South Dakota 57105
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Nashville, Tennessee 37232
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Austin, Texas 78759
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Baytown, Texas 77521
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Beaumont, Texas 77701
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Beaumont, Texas 77702
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Bellaire, Texas 77401
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Corsicana, Texas 75110
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Dallas, Texas 75231
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El Paso, Texas 79912
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Frisco, Texas 75034
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Houston, Texas 77030
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Houston, Texas 77065
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Houston, Texas 77099
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Kerrville, Texas 78028
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McKinney, Texas 75069
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San Antonio, Texas 78215
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San Antonio, Texas 78229
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San Antonio, Texas 78249
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Tyler, Texas 75708
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West Jordan, Utah 84088
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Burlington, Vermont 05405
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Burke, Virginia 22015
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Bellingham, Washington 98225
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Vancouver, Washington 98664
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Beijing, 100050
China
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Beijing, 100191
China
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Bengbu, 233004
China
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Chengdu, 610066
China
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Chongqing, 401122
China
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Hohhot, 10050
China
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Mianyang, 621000
China
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Shanghai, 200062
China
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Shanghai, 200433
China
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Shanghai,
China
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Shantou, 515041
China
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Shenyang, 110004
China
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Shenzhen, 518026
China
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Suzhou, 215002
China
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Taizhou, 318000
China
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Tianjin, 300050
China
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Tianjin, 300134
China
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Tianjin, 300211
China
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Wuhan, 430000
China
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Yanji, 133000
China
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Yantai, 264000
China
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Zhongshan, 528400
China
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Chihuahua City, 31000
Mexico
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Chihuahua City, 31238
Mexico
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Guadalajara, 44100
Mexico
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Guadalajara, 44500
Mexico
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Monterrey, 64465
Mexico
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Durban, 3630
South Africa
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Durban, 4001
South Africa
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Durban, 4092
South Africa
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Krugersdorp, 1739
South Africa
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Middelburg, 1055
South Africa
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Panorama, 7500
South Africa
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Somerset West, 7130
South Africa
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Welkom, 9460
South Africa