Actively Recruiting
Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma
Led by AstraZeneca · Updated on 2026-05-01
440
Participants Needed
135
Research Sites
177 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
P
Parexel
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed clinical diagnosis of asthma for at least 12 months
- Receiving stable scheduled asthma maintenance therapy for at least 3 months
- Using inhaled short-acting b22-agonist (SABA) as needed
- History of at least one severe asthma exacerbation within 12 months
- Use of Sponsor-provided albuterol sulfate inhalation aerosol
- Demonstrate acceptable metered-dose inhaler administration technique without spacers
- Able to perform reproducible peak expiratory flow measurements
- Adhere to protocol-specific contraception methods
- Negative urine pregnancy test for participants of childbearing potential
- Body mass index (BMI) less than 40 kg/m
- Capable of giving assent and caregiver capable of giving written informed consent
You will not qualify if you...
- Life-threatening asthma with history of intubation, respiratory arrest, or related severe events
- More than 3 severe asthma exacerbations within 12 months before screening
- Recent lower respiratory infection or severe asthma exacerbation treated with systemic corticosteroids within 4 weeks
- Unresolved upper respiratory infection requiring antibiotics
- Current smokers, former smokers with over 10 pack-years, or quit less than 6 months ago including vaping and marijuana
- Other significant lung diseases or regular oxygen use
- Clinically significant diseases including cardiovascular, hepatic, renal, hematological, neuropsychological, endocrine, or gastrointestinal disorders
- Cancer not in complete remission for at least 5 years
- Recent hospitalization for psychiatric disorder or suicide attempt within one year
- Significant alcohol or drug abuse
- Use of oral corticosteroids within 4 weeks or chronic use in prior 3 months
- Use of oral short-acting beta-agonists within one month
- Known or suspected allergy to albuterol, budesonide, or their excipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 135 locations
1
Research Site
Anchorage, Alaska, United States, 99508
Actively Recruiting
2
Research Site
Gilbert, Arizona, United States, 85234
Actively Recruiting
3
Research Site
Phoenix, Arizona, United States, 85016
Not Yet Recruiting
4
Research Site
Little Rock, Arkansas, United States, 72202
Completed
5
Research Site
Long Beach, California, United States, 90806
Actively Recruiting
6
Research Site
Long Beach, California, United States, 90815
Actively Recruiting
7
Research Site
Madera, California, United States, 93636
Not Yet Recruiting
8
Research Site
Mission Viejo, California, United States, 92691
Actively Recruiting
9
Research Site
Moreno Valley, California, United States, 92553
Actively Recruiting
10
Research Site
Orange, California, United States, 92868
Actively Recruiting
11
Research Site
Riverside, California, United States, 92506
Actively Recruiting
12
Research Site
San Diego, California, United States, 92123
Actively Recruiting
13
Research Site
San Diego, California, United States, 92123
Not Yet Recruiting
14
Research Site
San Francisco, California, United States, 94143
Withdrawn
15
Research Site
Westminster, California, United States, 92683
Actively Recruiting
16
Research Site
Denver, Colorado, United States, 80206
Actively Recruiting
17
Research Site
Wilmington, Delaware, United States, 19803
Actively Recruiting
18
Research Site
Destin, Florida, United States, 32541
Actively Recruiting
19
Research Site
Jacksonville, Florida, United States, 32207
Actively Recruiting
20
Research Site
Kendall, Florida, United States, 33176
Not Yet Recruiting
21
Research Site
Largo, Florida, United States, 33777
Completed
22
Research Site
Miami, Florida, United States, 33145
Actively Recruiting
23
Research Site
Pembroke Pines, Florida, United States, 33026
Not Yet Recruiting
24
Research Site
Tampa, Florida, United States, 33613
Withdrawn
25
Research Site
Atlanta, Georgia, United States, 30329
Actively Recruiting
26
Research Site
Columbus, Georgia, United States, 31904
Actively Recruiting
27
Research Site
Fayetteville, Georgia, United States, 30214
Actively Recruiting
28
Research Site
Snellville, Georgia, United States, 30078
Not Yet Recruiting
29
Research Site
Meridian, Idaho, United States, 83646
Withdrawn
30
Research Site
Normal, Illinois, United States, 61761
Actively Recruiting
31
Research Site
River Forest, Illinois, United States, 60305
Withdrawn
32
Research Site
Indianapolis, Indiana, United States, 46202
Actively Recruiting
33
Research Site
Kansas City, Kansas, United States, 66160
Actively Recruiting
34
Research Site
Louisville, Kentucky, United States, 40202
Actively Recruiting
35
Research Site
Lafayette, Louisiana, United States, 70508
Actively Recruiting
36
Research Site
New Orleans, Louisiana, United States, 70121
Actively Recruiting
37
Research Site
Ellicott City, Maryland, United States, 21043
Actively Recruiting
38
Research Site
Silver Spring, Maryland, United States, 20902
Actively Recruiting
39
Research Site
White Marsh, Maryland, United States, 21162
Actively Recruiting
40
Research Site
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
41
Research Site
Detroit, Michigan, United States, 48201
Actively Recruiting
42
Research Site
Mankato, Minnesota, United States, 56001
Active, Not Recruiting
43
Research Site
Kansas City, Missouri, United States, 64108
Withdrawn
44
Research Site
Kansas City, Missouri, United States, 64118
Actively Recruiting
45
Research Site
Missoula, Montana, United States, 59804
Actively Recruiting
46
Research Site
Lincoln, Nebraska, United States, 68510
Actively Recruiting
47
Research Site
Lincoln, Nebraska, United States, 68516
Actively Recruiting
48
Research Site
Omaha, Nebraska, United States, 68114
Actively Recruiting
49
Research Site
Newark, New Jersey, United States, 07103
Actively Recruiting
50
Research Site
Northfield, New Jersey, United States, 08225
Actively Recruiting
51
Research Site
Ocean City, New Jersey, United States, 07712
Actively Recruiting
52
Research Site
Paramus, New Jersey, United States, 07652
Actively Recruiting
53
Research Site
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
54
Research Site
Albany, New York, United States, 12208
Actively Recruiting
55
Research Site
Cortland, New York, United States, 13045
Actively Recruiting
56
Research Site
Hawthorne, New York, United States, 10532
Actively Recruiting
57
Research Site
Hollis, New York, United States, 11423
Withdrawn
58
Research Site
New York, New York, United States, 10019
Withdrawn
59
Research Site
New York, New York, United States, 10032
Actively Recruiting
60
Research Site
Rochester, New York, United States, 14607
Completed
61
Research Site
The Bronx, New York, United States, 10459
Actively Recruiting
62
Research Site
The Bronx, New York, United States, 10461
Actively Recruiting
63
Research Site
Vestal, New York, United States, 13850
Actively Recruiting
64
Research Site
Vestal, New York, United States, 13850
Withdrawn
65
Research Site
Watertown, New York, United States, 13601
Actively Recruiting
66
Research Site
Charlotte, North Carolina, United States, 28277
Withdrawn
67
Research Site
Cincinnati, Ohio, United States, 45229
Not Yet Recruiting
68
Research Site
Columbus, Ohio, United States, 43205
Not Yet Recruiting
69
Research Site
Columbus, Ohio, United States, 43228
Not Yet Recruiting
70
Research Site
Dayton, Ohio, United States, 45424
Actively Recruiting
71
Research Site
Findlay, Ohio, United States, 45840
Actively Recruiting
72
Research Site
Toledo, Ohio, United States, 43617
Actively Recruiting
73
Research Site
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
74
Research Site
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
75
Research Site
Yukon, Oklahoma, United States, 73099
Actively Recruiting
76
Research Site
Pittsburgh, Pennsylvania, United States, 15241
Actively Recruiting
77
Research Site
Charleston, South Carolina, United States, 29425
Actively Recruiting
78
Research Site
Rock Hill, South Carolina, United States, 29730
Active, Not Recruiting
79
Research Site
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
80
Research Site
Nashville, Tennessee, United States, 37232
Actively Recruiting
81
Research Site
Austin, Texas, United States, 78759
Actively Recruiting
82
Research Site
Baytown, Texas, United States, 77521
Actively Recruiting
83
Research Site
Beaumont, Texas, United States, 77701
Actively Recruiting
84
Research Site
Beaumont, Texas, United States, 77702
Not Yet Recruiting
85
Research Site
Bellaire, Texas, United States, 77401
Actively Recruiting
86
Research Site
Corsicana, Texas, United States, 75110
Actively Recruiting
87
Research Site
Dallas, Texas, United States, 75231
Actively Recruiting
88
Research Site
Frisco, Texas, United States, 75034
Withdrawn
89
Research Site
Houston, Texas, United States, 77065
Actively Recruiting
90
Research Site
Houston, Texas, United States, 77099
Actively Recruiting
91
Research Site
Kerrville, Texas, United States, 78028
Withdrawn
92
Research Site
McKinney, Texas, United States, 75069
Actively Recruiting
93
Research Site
San Antonio, Texas, United States, 78215
Actively Recruiting
94
Research Site
San Antonio, Texas, United States, 78229
Actively Recruiting
95
Research Site
Tyler, Texas, United States, 75708
Completed
96
Research Site
West Jordan, Utah, United States, 84088
Actively Recruiting
97
Research Site
Burlington, Vermont, United States, 05405
Actively Recruiting
98
Research Site
Burke, Virginia, United States, 22015
Withdrawn
99
Research Site
Bellingham, Washington, United States, 98225
Completed
100
Research Site
Vancouver, Washington, United States, 98664
Actively Recruiting
101
Research Site
Beijing, China, 100050
Actively Recruiting
102
Research Site
Beijing, China, 100191
Actively Recruiting
103
Research Site
Bengbu, China, 233004
Actively Recruiting
104
Research Site
Chengdu, China, 610066
Actively Recruiting
105
Research Site
Chongqing, China, 401122
Actively Recruiting
106
Research Site
Hohhot, China, 10050
Actively Recruiting
107
Research Site
Mianyang, China, 621000
Actively Recruiting
108
Research Site
Shanghai, China, 200062
Actively Recruiting
109
Research Site
Shanghai, China, 200433
Actively Recruiting
110
Research Site
Shanghai, China
Actively Recruiting
111
Research Site
Shantou, China, 515041
Actively Recruiting
112
Research Site
Shenyang, China, 110004
Actively Recruiting
113
Research Site
Shenzhen, China, 518026
Actively Recruiting
114
Research Site
Suzhou, China, 215002
Actively Recruiting
115
Research Site
Taizhou, China, 318000
Actively Recruiting
116
Research Site
Tianjin, China, 300050
Actively Recruiting
117
Research Site
Tianjin, China, 300134
Actively Recruiting
118
Research Site
Tianjin, China, 300211
Actively Recruiting
119
Research Site
Wuhan, China, 430000
Actively Recruiting
120
Research Site
Yanji, China, 133000
Actively Recruiting
121
Research Site
Yantai, China, 264000
Actively Recruiting
122
Research Site
Zhongshan, China, 528400
Actively Recruiting
123
Research Site
Chihuahua City, Mexico, 31000
Actively Recruiting
124
Research Site
Chihuahua City, Mexico, 31238
Actively Recruiting
125
Research Site
Guadalajara, Mexico, 44100
Actively Recruiting
126
Research Site
Guadalajara, Mexico, 44500
Actively Recruiting
127
Research Site
Monterrey, Mexico, 64465
Actively Recruiting
128
Research Site
Durban, South Africa, 3630
Actively Recruiting
129
Research Site
Durban, South Africa, 4001
Actively Recruiting
130
Research Site
Durban, South Africa, 4092
Actively Recruiting
131
Research Site
Krugersdorp, South Africa, 1739
Actively Recruiting
132
Research Site
Middelburg, South Africa, 1055
Actively Recruiting
133
Research Site
Panorama, South Africa, 7500
Actively Recruiting
134
Research Site
Somerset West, South Africa, 7130
Not Yet Recruiting
135
Research Site
Welkom, South Africa, 9460
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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