A Randomized, Double-blind, Multicentre, Event-driven, Parallel Group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Symptomatic Chinese Adults With Asthma (BAIYUN)

Status: Recruiting
Location: See all (98) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Documented physician-diagnosed asthma for at least 12 months prior to Visit 1

• Receiving 1 of the scheduled asthma maintenance therapies for 3 months with stable dosing for at least the last 4 weeks before Visit 1

• Pre-bronchodilator FEV1 of ≥ 40% to \< 90% predicted normal value for adults.

• Documented reversibility to albuterol

• A documented history of at least one severe asthma exacerbation within 12 months before Visit 1

• ACQ-7 score ≥ 1.5 assessed at Visit 1

• Receiving inhaled SABA as needed prior to Visit 1 for at least 3 months

• Use of Sponsor-provided salbutamol sulfate inhalation aerosol as needed medication due to asthma symptoms on at least 3 days during the last week of the run-in period before Visit 2

⁃ Demonstrate acceptable MDI administration technique as assessed by the investigator; use of spacers is prohibited

⁃ Able to perform acceptable and reproducible PEF measurements as assessed by the investigator

⁃ BMI \< 40 kg/m2

⁃ Negative pregnancy test (urine at Visit 1) for female participants of childbearing potential

⁃ Women of childbearing potential must agree to prevent pregnancy

⁃ Compliance: must be willing to remain at the study site as required per protocol and complete all visit assessments

Locations
Other Locations
China
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Baotou
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Baotou
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NOT_YET_RECRUITING
Beijing
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Beijing
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Beijing
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Beijing
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Changchun
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Changsha
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Changsha
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Chengdu
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Chengdu
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Chengdu
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Chengdu
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Chengdu
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Chongqing
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Chongqing
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Chongqing
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Chuangchun
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Dazhou
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Deyang
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Ganzhou
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Guangyuan
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Guangzhou
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Guangzhou
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Guangzhou
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Guangzhou
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Guangzhou
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Haikou
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Hangzhou
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Hangzhou
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Hefei
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Hefei
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Hefei
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Heifei
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Hohhot
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Hohhot
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Huizhou
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Huizhou
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Jinan
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Jinhua
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Jining
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Kunming
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Lanzhou
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Linhai
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Luoyang
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Luzhou
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Mianyang
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Nanchang
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Nanchong
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Nanjing
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Nanjing
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Nantong
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Ningbo
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Panjin
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Panzhihua
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Pingxiang
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Qingdao
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Rui’an
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Sanya
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Shanghai
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Shanghai
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Shanghai
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Shenyang
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Shenyang
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Shenzhen
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Shenzhen
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Shijiazhuang
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Shijiazhuang
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Suining
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Taiyuan
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Taiyuan
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Tianjin
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Ürümqi
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Wenzhou
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Wenzhou
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Wuhan
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Wuhan
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Wuhu
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Xi'an
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Xiamen
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Xintai
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Xinxiang
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Xuzhou
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Xuzhou
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Yangzhou
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Yibin
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Yinchuan
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Yinchuan
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Yueyang
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Yuhuan
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Zhengzhou
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Zhengzhou
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Zhuhai
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Zhuji
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Zibo
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Zigong
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Zunyi
Hong Kong Special Administrative Region
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Hong Kong
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2024-06-17
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 790
Treatments
Experimental: BDA MDI
BDA MDI 160/180 μg (administered as 2 actuations of BDA MDI 80/90 μg)
Active_comparator: AS MDI
AS MDI 180 μg (administered as 2 actuations of AS MDI 90 μg)
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov

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