Actively Recruiting
BRISOTE: A Randomised, Double-Blind, Active-Controlled Study Evaluating Benralizumab 30 mg SC in Eosinophilic Asthma Patients Uncontrolled on Medium-Dose ICS Plus LABA
Led by AstraZeneca · Updated on 2026-05-13
400
Participants Needed
160
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates the efficacy and safety of benralizumab as an additional treatment for people aged 12 to 75 with uncontrolled eosinophilic asthma. These participants are already treated with a medium-dose inhaled corticosteroid and long-acting beta2-agonist (ICS-LABA). The study compares adding benralizumab to increasing the inhaled therapy to a higher dose ICS-LABA. The research is a randomized, double-blind, active-controlled phase 3b trial designed to evaluate these treatments in people with a history of eosinophilic asthma who remain uncontrolled on medium-dose ICS-LABA with or without other controllers except oral corticosteroids. Participants are randomly assigned to one of two groups: one receives benralizumab 30 mg by subcutaneous injection along with medium-dose ICS-LABA, and the other receives a placebo injection plus high-dose ICS-LABA. Doses of benralizumab or placebo are given every 4 weeks for the first three doses, then every 8 weeks, with up to seven injections during the study. The study treatment schedules continue for 48 weeks. During the study, participants will undergo assessments including lung function tests, asthma control questionnaires, and quality of life surveys. Researchers will track the annual rate of asthma exacerbations, time to first exacerbation, and safety events throughout the 48-week period. Compliance with asthma controller medication is monitored via daily diaries. This comprehensive evaluation helps understand the impact of adding benralizumab compared to increasing inhaled therapy dose in uncontrolled eosinophilic asthma.
CONDITIONS
Brief Title
Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Be between 12 and 75 years of age
- Have a documented history of physician-diagnosed asthma requiring treatment with at least medium-dose ICS and a LABA for at least 12 months before the first visit
- Have been treated with medium-dose ICS and LABA for at least 3 months before the first visit, with or without other asthma controllers (excluding oral corticosteroids)
- Weigh at least 35 kilograms
- Have a pre-bronchodilator FEV1 of 90% predicted or less
- Have had at least 2 asthma exacerbations in the 12 months before giving informed consent
- Have an ACQ-6 score of 1.5 or higher at the first visit and at least once during the run-in period
- Show evidence of asthma by excessive variability in lung function as defined in the protocol
- Have a peripheral blood eosinophil count of at least 150 cells per microliter
- Have at least 70% compliance with usual asthma controller ICS-LABA during the run-in period based on daily asthma diary
You will not qualify if you...
- Have other important pulmonary diseases besides asthma or systemic diseases associated with high eosinophil counts
- Have had an asthma exacerbation needing systemic corticosteroids or a respiratory infection requiring antibiotics or antivirals within 30 days before consent or during screening
- Have any unstable disorder that could affect study participation
- Have clinically significant chronic or ongoing active infections needing systemic treatment
- Be participating in another clinical study with an investigational product or post-authorization safety study
- Have a history of alcohol or drug abuse in the past 12 months
- Be a current smoker or a former smoker with 10 or more pack-years of smoking history; former smokers must have quit at least 6 months before the first visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 weeks
Participants receive subcutaneous injections of benralizumab or placebo in addition to inhaled corticosteroid-long-acting β2-agonist therapy. The first 3 doses are given every 4 weeks, followed by doses every 8 weeks.
7 visits for subcutaneous injections over the treatment period
Trial Site Locations
Total: 160 locations
1
Research Site
Chandler, Arizona, United States, 85224
Withdrawn
2
Research Site
Sun City, Arizona, United States, 85351
Actively Recruiting
3
Research Site
Tucson, Arizona, United States, 85704
Actively Recruiting
4
Research Site
Bakersfield, California, United States, 93301
Not Yet Recruiting
5
Research Site
Inglewood, California, United States, 90301
Actively Recruiting
6
Research Site
Modesto, California, United States, 95355
Not Yet Recruiting
7
Research Site
Newport Beach, California, United States, 92663
Actively Recruiting
8
Research Site
Pasadena, California, United States, 91101
Actively Recruiting
9
Research Site
Denver, Colorado, United States, 80206
Withdrawn
10
Research Site
Cape Coral, Florida, United States, 33990
Actively Recruiting
11
Research Site
Hialeah, Florida, United States, 33015
Not Yet Recruiting
12
Research Site
Lauderdale Lakes, Florida, United States, 33313
Actively Recruiting
13
Research Site
Leesburg, Florida, United States, 34748
Actively Recruiting
14
Research Site
Miami, Florida, United States, 33122
Not Yet Recruiting
15
Research Site
Miami, Florida, United States, 33155
Not Yet Recruiting
16
Research Site
Miami, Florida, United States, 33175
Actively Recruiting
17
Research Site
Orlando, Florida, United States, 32819
Actively Recruiting
18
Research Site
Plantation, Florida, United States, 33324
Not Yet Recruiting
19
Research Site
Tampa, Florida, United States, 33607
Actively Recruiting
20
Research Site
Winter Park, Florida, United States, 32789
Actively Recruiting
21
Research Site
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
22
Research Site
Henderson, Nevada, United States, 89052
Actively Recruiting
23
Research Site
Northfield, New Jersey, United States, 08225
Actively Recruiting
24
Research Site
Union City, New Jersey, United States, 07087
Not Yet Recruiting
25
Research Site
New Hyde Park, New York, United States, 11042
Actively Recruiting
26
Research Site
The Bronx, New York, United States, 10459
Actively Recruiting
27
Research Site
Oklahoma City, Oklahoma, United States, 73103
Withdrawn
28
Research Site
Oklahoma City, Oklahoma, United States, 73111
Actively Recruiting
29
Research Site
DuBois, Pennsylvania, United States, 15801
Actively Recruiting
30
Research Site
Warwick, Rhode Island, United States, 02886
Actively Recruiting
31
Research Site
Greenville, South Carolina, United States, 29607
Actively Recruiting
32
Research Site
Houston, Texas, United States, 77099
Not Yet Recruiting
33
Research Site
McKinney, Texas, United States, 75069
Actively Recruiting
34
Research Site
San Antonio, Texas, United States, 78251
Actively Recruiting
35
Research Site
Dimitrovgrad, Bulgaria, 6400
Not Yet Recruiting
36
Research Site
Haskovo, Bulgaria, 6300
Not Yet Recruiting
37
Research Site
Pleven, Bulgaria, 5800
Not Yet Recruiting
38
Research Site
Plovdiv, Bulgaria, 4002
Actively Recruiting
39
Research Site
Plovdiv, Bulgaria, 4023
Not Yet Recruiting
40
Research Site
Rousse, Bulgaria, 7002
Actively Recruiting
41
Research Site
Sofia, Bulgaria, 1142
Actively Recruiting
42
Research Site
Sofia, Bulgaria, 1431
Actively Recruiting
43
Research Site
Stara Zagora, Bulgaria, 6000
Actively Recruiting
44
Research Site
Stara Zagora, Bulgaria, 6000
Not Yet Recruiting
45
Research Site
Edmonton, Alberta, Canada, T6G 2C8
Withdrawn
46
Research Site
Kamloops, British Columbia, Canada, V2C 5T1
Actively Recruiting
47
Research Site
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
48
Research Site
Ajax, Ontario, Canada, L1S 2J5
Actively Recruiting
49
Research Site
Toronto, Ontario, Canada, M5T 3A9
Actively Recruiting
50
Research Site
Windsor, Ontario, Canada, N8X 1T3
Actively Recruiting
51
Research Site
Québec, Quebec, Canada, G1G 3Y8
Actively Recruiting
52
Research Site
Sainte-Foy, Quebec, Canada, G1V 4G5
Actively Recruiting
53
Research Site
Beijing, China, 100020
Actively Recruiting
54
Research Site
Beijing, China, 100044
Actively Recruiting
55
Research Site
Beijing, China, 102218
Actively Recruiting
56
Research Site
Changsha, China, 410004
Actively Recruiting
57
Research Site
Chongqing, China, 400042
Actively Recruiting
58
Research Site
Fuzhou, China, 350001
Not Yet Recruiting
59
Research Site
Fuzhou, China, 350005
Not Yet Recruiting
60
Research Site
Fuzhou, China, 350008
Actively Recruiting
61
Research Site
Guangzhou, China, 510120
Actively Recruiting
62
Research Site
Guangzhou, China, 510180
Actively Recruiting
63
Research Site
Hangzhou, China, 31000
Actively Recruiting
64
Research Site
Hangzhou, China, 310014
Actively Recruiting
65
Research Site
Hefei, China, 230061
Actively Recruiting
66
Research Site
Huizhou, China, 516002
Actively Recruiting
67
Research Site
Jinan, China, 250021
Actively Recruiting
68
Research Site
Linyi, China, 276100
Not Yet Recruiting
69
Research Site
Ningbo, China, 315020
Actively Recruiting
70
Research Site
Qinhuangdao, China
Actively Recruiting
71
Research Site
Shanghai, China, 200080
Actively Recruiting
72
Research Site
Shanghai, China, 200433
Actively Recruiting
73
Research Site
Wenzhou, China, 325027
Actively Recruiting
74
Research Site
Wuhan, China, 430030
Actively Recruiting
75
Research Site
Xuzhou, China, 221000
Actively Recruiting
76
Research Site
Yinchuan, China, 750004
Actively Recruiting
77
Research Site
Zhengzhou, China, 450000
Actively Recruiting
78
Research Site
Bayonne, France, 64109
Actively Recruiting
79
Research Site
Créteil, France, 94010
Actively Recruiting
80
Research Site
La Tronche, France, 38043
Actively Recruiting
81
Research Site
Lyon, France, 69317
Actively Recruiting
82
Research Site
Montpellier, France, 34295
Actively Recruiting
83
Research Site
Pessac, France, F-33604
Actively Recruiting
84
Research Site
Suresnes, France, 92150
Actively Recruiting
85
Research Site
Toulouse, France, 31059
Actively Recruiting
86
Research Site
Villeurbanne, France, 69100
Actively Recruiting
87
Research Site
Berlin, Germany, 10367
Actively Recruiting
88
Research Site
Berlin, Germany, 10717
Actively Recruiting
89
Research Site
Bonn, Germany, 53119
Not Yet Recruiting
90
Research Site
Cottbus, Germany, 03050
Actively Recruiting
91
Research Site
Delitzsch, Germany, 4509
Withdrawn
92
Research Site
Frankfurt am Main, Germany, 60389
Not Yet Recruiting
93
Research Site
Geesthacht, Germany, 21502
Actively Recruiting
94
Research Site
Hemer, Germany, 58675
Not Yet Recruiting
95
Research Site
Landsberg, Germany, 86899
Not Yet Recruiting
96
Research Site
Langen, Germany, 63225
Not Yet Recruiting
97
Research Site
Lübeck, Germany, 23552
Actively Recruiting
98
Research Site
Mönchengladbach, Germany, 41063
Not Yet Recruiting
99
Research Site
München, Germany, 81377
Suspended
100
Research Site
München-Pasing, Germany, 81241
Not Yet Recruiting
101
Research Site
Neu-Isenburg, Germany, 63263
Not Yet Recruiting
102
Research Site
Wiesbaden, Germany, 65183
Actively Recruiting
103
Research Site
Witten, Germany, 58452
Not Yet Recruiting
104
Research Site
Zossen, Germany, 15806
Not Yet Recruiting
105
Research Site
Hong Kong, Hong Kong, 999077
Withdrawn
106
Research Site
Pok Fu Lam, Hong Kong, 999077
Actively Recruiting
107
Research Site
Shatin, Hong Kong, 0000
Actively Recruiting
108
Research Site
Ballinasloe, Ireland, H53 T971
Actively Recruiting
109
Research Site
Cork, Ireland, T12 DFK4
Actively Recruiting
110
Research Site
Dublin, Ireland, D15 X40D
Actively Recruiting
111
Research Site
Moneymore, Ireland, A92 VW28
Actively Recruiting
112
Research Site
Bari, Italy, 70124
Not Yet Recruiting
113
Research Site
Bergamo, Italy, 24127
Actively Recruiting
114
Research Site
Brescia, Italy, 25123
Actively Recruiting
115
Research Site
Cagliari, Italy, 09122
Actively Recruiting
116
Research Site
Catanzaro, Italy, 88100
Actively Recruiting
117
Research Site
Genoa, Italy, 16132
Actively Recruiting
118
Research Site
Milan, Italy, 20122
Actively Recruiting
119
Research Site
Modena, Italy, 41124
Withdrawn
120
Research Site
Montebelluna, Italy, 31044
Actively Recruiting
121
Research Site
Naples, Italy, 80131
Actively Recruiting
122
Research Site
Roma, Italy, 00161
Actively Recruiting
123
Research Site
Roma, Italy, 00168
Actively Recruiting
124
Research Site
Rozzano, Italy, 20089
Actively Recruiting
125
Research Site
Verona, Italy, 37124
Actively Recruiting
126
Research Site
Lørenskog, Norway, N-1478
Actively Recruiting
127
Research Site
Alcorcón, Spain, 28922
Actively Recruiting
128
Research Site
Alzira (Valencia), Spain, 46600
Actively Recruiting
129
Research Site
Badalona, Spain, 08916
Actively Recruiting
130
Research Site
Barakaldo, Spain, 48902
Actively Recruiting
131
Research Site
Barcelona, Spain, 08025
Actively Recruiting
132
Research Site
Barcelona, Spain, 08035
Actively Recruiting
133
Research Site
Burgos, Spain, 09006
Actively Recruiting
134
Research Site
Cáceres, Spain, 10003
Actively Recruiting
135
Research Site
Granada, Spain, 18014
Actively Recruiting
136
Research Site
Jerez de la Frontera, Spain, 11407
Actively Recruiting
137
Research Site
Lugo, Spain, 27003
Actively Recruiting
138
Research Site
Madrid, Spain, 28034
Actively Recruiting
139
Research Site
Madrid, Spain, 28041
Actively Recruiting
140
Research Site
Madrid, Spain, 28050
Not Yet Recruiting
141
Research Site
Marbella, Spain, 29600
Actively Recruiting
142
Research Site
Marbella, Spain, 29603
Actively Recruiting
143
Research Site
Málaga, Spain, 29010
Actively Recruiting
144
Research Site
Mérida, Spain, 06800
Actively Recruiting
145
Research Site
Palma de Mallorca, Spain, 7120
Actively Recruiting
146
Research Site
Santander, Spain, 39008
Actively Recruiting
147
Research Site
Aarau, Switzerland, 5001
Actively Recruiting
148
Research Site
Basel, Switzerland, 4031
Actively Recruiting
149
Research Site
Lausanne, Switzerland, 1011
Actively Recruiting
150
Research Site
Sankt Gallen, Switzerland, 9007
Actively Recruiting
151
Research Site
Sion, Switzerland, 1951
Actively Recruiting
152
Research Site
Belfast, United Kingdom, BT9 7AB
Actively Recruiting
153
Research Site
Birmingham, United Kingdom, B9 5SS
Actively Recruiting
154
Research Site
Bradford, United Kingdom, BD9 6RJ
Actively Recruiting
155
Research Site
Bristol, United Kingdom, BS10 5NB
Actively Recruiting
156
Research Site
Chorley, United Kingdom, PR7 1PP
Actively Recruiting
157
Research Site
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
158
Research Site
Liverpool, United Kingdom, L7 8XP
Not Yet Recruiting
159
Research Site
Nottingham, United Kingdom, NG7 2UH
Withdrawn
160
Research Site
Portsmouth, United Kingdom, PO6 3LY
Withdrawn
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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