AstraZeneca
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.
Asthma
BDA MDI
AS MDI
PHASE3
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.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 440 participants |
Masking : | DOUBLE |
Primary Purpose : | TREATMENT |
Official Title : | A Randomized, Double-blind, Multicenter, Parallel Group, Phase IIIb 52 Week Study Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma (ACADIA) |
Actual Study Start Date : | 2024-05-20 |
Estimated Primary Completion Date : | 2027-10-13 |
Estimated Study Completion Date : | 2027-10-13 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 12 Years to 17 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
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Anchorage, Alaska, United States, 99508
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Gilbert, arizona, United States, 85234
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Little Rock, arkansas, United States, 72202
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Mission Viejo, California, United States, 92691
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Orange, California, United States, 92868
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Riverside, California, United States, 92506
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San Diego, California, United States, 92123
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San Francisco, California, United States, 94143
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Westminster, California, United States, 92683
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Denver, Colorado, United States, 80206
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Wilmington, Delaware, United States, 19803
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Destin, Florida, United States, 32541
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Jacksonville, Florida, United States, 32207
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Miami, Florida, United States, 33145
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Seminole, Florida, United States, 33777
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Columbus, Georgia, United States, 31904
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Fayetteville, Georgia, United States, 30214
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Normal, Illinois, United States, 61761
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River Forest, Illinois, United States, 60305
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Indianapolis, Indiana, United States, 46202
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Louisville, Kentucky, United States, 40202
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Lafayette, Louisiana, United States, 70508
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New Orleans, Louisiana, United States, 70121
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Silver Spring, Maryland, United States, 20902
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White Marsh, Maryland, United States, 21162
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Detroit, Michigan, United States, 48201
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Mankato, Minnesota, United States, 56001
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Missoula, Montana, United States, 59804
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Lincoln, Nebraska, United States, 68510
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Omaha, Nebraska, United States, 68114
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Newark, New Jersey, United States, 07103
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Northfield, New Jersey, United States, 08225
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Ocean City, New Jersey, United States, 07712
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Albuquerque, New Mexico, United States, 87106
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Bronx, New York, United States, 10459
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Cortland, New York, United States, 13045
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Hawthorne, New York, United States, 10532
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Hollis, New York, United States, 11423
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New York, New York, United States, 10019
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New York, New York, United States, 10032
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Rochester, New York, United States, 14607
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Vestal, New York, United States, 13850
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Vestal, New York, United States, 13850
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Watertown, New York, United States, 13601
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Charlotte, North Carolina, United States, 28277
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Cincinnati, Ohio, United States, 45229
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Columbus, Ohio, United States, 43205
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Dayton, Ohio, United States, 45424
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Toledo, Ohio, United States, 43617
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Oklahoma City, Oklahoma, United States, 73104
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Oklahoma City, Oklahoma, United States, 73120
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Yukon, Oklahoma, United States, 73099
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Pittsburgh, Pennsylvania, United States, 15241
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Charleston, South Carolina, United States, 29425
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Rock Hill, South Carolina, United States, 29730
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Sioux Falls, South Dakota, United States, 57105
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Nashville, Tennessee, United States, 37232
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Austin, Texas, United States, 78759
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Baytown, Texas, United States, 77521
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Beaumont, Texas, United States, 77701
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Corsicana, Texas, United States, 75110
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dallas, Texas, United States, 75231
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Frisco, Texas, United States, 75034
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Houston, Texas, United States, 77065
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Houston, Texas, United States, 77099
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Kerrville, Texas, United States, 78028
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McKinney, Texas, United States, 75069
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Saint Anthony, Texas, United States, 78215
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Saint Anthony, Texas, United States, 78229
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West Jordan, Utah, United States, 84088
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Burlington, Vermont, United States, 05405
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Burke, Virginia, United States, 22015
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Bellingham, Washington, United States, 98225
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Vancouver, Washington, United States, 98664
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Beijing, China, 100050
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Beijing, China, 100191
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Bengbu, China, 233060
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Chengdu, China, 610066
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Chongqing, China, 401122
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Hohhot, China, 10050
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Mianyang, China, 621000
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Shanghai, China, 200062
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Shanghai, China, 200433
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Shanghai, China,
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Shenyang, China, 110004
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Shenzhen, China, 518034
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Taizhou, China, 318000
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Tianjin, China, 300052
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Tianjin, China, 300134
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Wuhan, China, 430000
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Which one, China, 133000
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Zhongshan, China, 528400