Actively Recruiting
A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma
Led by AstraZeneca · Updated on 2026-04-14
790
Participants Needed
102
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An event-driven, Phase III study to evaluate the efficacy and safety of BDA MDI compared with AS MDI in reducing the risk of a severe asthma exacerbation in symptomatic Chinese adults with asthma.
CONDITIONS
Official Title
A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented diagnosis of asthma by a physician for at least 12 months before Visit 1
- Receiving one scheduled asthma maintenance therapy for at least 3 months with stable dosing for the last 4 weeks before Visit 1
- Pre-bronchodilator lung function (FEV1) between 40% and less than 90% of predicted normal for adults
- Documented lung function improvement after albuterol use
- History of at least one severe asthma exacerbation within 12 months before Visit 1
- Asthma Control Questionnaire (ACQ-7) score of 1.5 or higher at Visit 1
- ACQ-5 score of 1.5 or higher at Visit 2
- Use of inhaled short-acting beta-agonist (SABA) as needed for at least 3 months before Visit 1
- Use of study-provided salbutamol inhaler on at least 3 days during the week before Visit 2
- Able to correctly use a metered dose inhaler (MDI) without a spacer as assessed by the investigator
- Able to perform acceptable and reproducible peak expiratory flow (PEF) measurements
- Body mass index (BMI) less than 40 kg/m2
- Female participants of childbearing potential must have a negative pregnancy test at Visit 1
- Women of childbearing potential must agree to use pregnancy prevention measures
- Willing and able to comply with study procedures and complete all required visits
You will not qualify if you...
- Diagnosis of chronic obstructive pulmonary disease (COPD) or other significant lung diseases
- Use of oral or systemic corticosteroids within 6 weeks before Visit 1
- Chronic use of oral corticosteroids for 3 weeks or more in the 3 months before Visit 1
- Use of biologic medicines or other prohibited medications within 3 months or 5 half-lives before Visit 1
- Current smokers, former smokers with more than 10 pack-years, or those who quit smoking less than 6 months before Visit 1
- History of life-threatening asthma requiring intubation or severe complications within 5 years before Visit 1
- Treatment for lower respiratory infection or asthma exacerbation within 6 weeks before Visit 1
- Upper respiratory infection requiring antibiotics not resolved within 7 days before Visit 1
- Significant laboratory abnormalities or clinically important diseases
- History of cancer not in remission for at least 5 years before Visit 1
- History of psychiatric illness, intellectual disability, or conditions affecting consent validity
- Known allergies to albuterol, budesonide, or inhaler components
- Inability to avoid prohibited medications during the study
- Receipt of live attenuated vaccine within 7 days before Visit 1
- Currently pregnant or breastfeeding
- More than one asthma exacerbation during the screening period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 102 locations
1
Research Site
Baotou, China, 014010
Actively Recruiting
2
Research Site
Baotou, China, 14010
Actively Recruiting
3
Research Site
Beijing, China, 100020
Actively Recruiting
4
Research Site
Beijing, China, 100029
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5
Research Site
Beijing, China, 100039
Actively Recruiting
6
Research Site
Beijing, China, 100191
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7
Research Site
Changchun, China, 130021
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8
Research Site
Changchun, China, 130041
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9
Research Site
Changsha, China, 410005
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10
Research Site
Changsha, China, 410015
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11
Research Site
Chengdu, China, 610000
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12
Research Site
Chengdu, China, 610021
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13
Research Site
Chengdu, China, 610041
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14
Research Site
Chengdu, China, 610072
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15
Research Site
Chengdu, China, 610500
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16
Research Site
Chizhou, China, 247099
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17
Research Site
Chongqing, China, 400010
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18
Research Site
Chongqing, China, 400037
Actively Recruiting
19
Research Site
Chongqing, China, 401320
Suspended
20
Research Site
Dazhou, China, 635000
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21
Research Site
Deyang, China, 618000
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22
Research Site
Ganzhou, China, 341099
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23
Research Site
Guangyuan, China, 628000
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24
Research Site
Guangzhou, China, 510000
Active, Not Recruiting
25
Research Site
Guangzhou, China, 510080
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26
Research Site
Guangzhou, China, 510080
Active, Not Recruiting
27
Research Site
Guangzhou, China, 510145
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28
Research Site
Guangzhou, China, 510163
Actively Recruiting
29
Research Site
Guangzhou, China, 510317
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30
Research Site
Haikou, China, 570208
Suspended
31
Research Site
Hangzhou, China, 310006
Actively Recruiting
32
Research Site
Hangzhou, China, 310009
Withdrawn
33
Research Site
Hefei, China, 133500
Actively Recruiting
34
Research Site
Hefei, China, 230061
Actively Recruiting
35
Research Site
Hefei, China, 230601
Actively Recruiting
36
Research Site
Heifei, China, 230011
Withdrawn
37
Research Site
Hohhot, China, 010017
Actively Recruiting
38
Research Site
Hohhot, China, 010050
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39
Research Site
Huizhou, China, 516001
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40
Research Site
Huizhou, China, 516002
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41
Research Site
Jinan, China, 250001
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42
Research Site
Jinhua, China
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43
Research Site
Jining, China, 272029
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44
Research Site
Kunming, China, 650032
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45
Research Site
Lanzhou, China, 730000
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46
Research Site
Linhai, China, 317000
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47
Research Site
Luoyang, China, 471000
Actively Recruiting
48
Research Site
Luzhou, China, 646000
Actively Recruiting
49
Research Site
Luzhou, China, 646000
Withdrawn
50
Research Site
Mianyang, China, 621000
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51
Research Site
Nanchang, China, 330006
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52
Research Site
Nanchong, China, 637000
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53
Research Site
Nanjing, China, 210009
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54
Research Site
Nanjing, China, 210012
Actively Recruiting
55
Research Site
Nantong, China, 226001
Withdrawn
56
Research Site
Ningbo, China, 315010
Withdrawn
57
Research Site
Panjin, China, 124009
Withdrawn
58
Research Site
Panzhihua, China, 617099
Actively Recruiting
59
Research Site
Pingxiang, China, 337055
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60
Research Site
Qingdao, China, 266011
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61
Research Site
Rui’an, China, 325200
Actively Recruiting
62
Research Site
Sanya, China, 572000
Withdrawn
63
Research Site
Shanghai, China, 200032
Actively Recruiting
64
Research Site
Shanghai, China, 200080
Completed
65
Research Site
Shanghai, China, 201199
Actively Recruiting
66
Research Site
Shenyang, China, 110004
Actively Recruiting
67
Research Site
Shenyang, China, 110032
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68
Research Site
Shenzhen, China, 518020
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69
Research Site
Shenzhen, China, 518036
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70
Research Site
Shijiazhuang, China, 054001
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71
Research Site
Shijiazhuang, China, 50051
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72
Research Site
Suining, China, 629000
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73
Research Site
Taiyuan, China, 030001
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74
Research Site
Taiyuan, China, 030032
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75
Research Site
Tianjin, China, 300050
Actively Recruiting
76
Research Site
Ürümqi, China, 830054
Actively Recruiting
77
Research Site
Wenzhou, China, 325000
Actively Recruiting
78
Research Site
Wenzhou, China, 325027
Actively Recruiting
79
Research Site
Wuhan, China, 430030
Actively Recruiting
80
Research Site
Wuhan, China, 430060
Actively Recruiting
81
Research Site
Wuhu, China, 241000
Withdrawn
82
Research Site
Xi'an, China, 710006
Suspended
83
Research Site
Xiamen, China, 361003
Actively Recruiting
84
Research Site
Xintai, China, 54031
Actively Recruiting
85
Research Site
Xinxiang, China, 453002
Actively Recruiting
86
Research Site
Xuzhou, China, 221000
Actively Recruiting
87
Research Site
Xuzhou, China, 221009
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88
Research Site
Yangzhou, China, 225003
Actively Recruiting
89
Research Site
Yibin, China, 610500
Actively Recruiting
90
Research Site
Yinchuan, China, 750001
Actively Recruiting
91
Research Site
Yinchuan, China, 750004
Active, Not Recruiting
92
Research Site
Yueyang, China, 414000
Withdrawn
93
Research Site
Yuhuan, China, 317600
Actively Recruiting
94
Research Site
Zhangzhou, China, 363099
Actively Recruiting
95
Research Site
Zhengzhou, China, 450003
Actively Recruiting
96
Research Site
Zhengzhou, China, 450052
Actively Recruiting
97
Research Site
Zhuhai, China, 519000
Actively Recruiting
98
Research Site
Zhuji, China, 311899
Actively Recruiting
99
Research Site
Zibo, China, 255036
Actively Recruiting
100
Research Site
Zigong, China, 643000
Withdrawn
101
Research Site
Zunyi, China, 563100
Actively Recruiting
102
Research Site
Hong Kong, Hong Kong, 999077
Active, Not 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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