RecruitingPhase 3NCT06471257

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma

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)

Sponsor

AstraZeneca

Enrollment

790 participants

Start Date

Jun 17, 2024

Study Type

INTERVENTIONAL

Conditions

Asthma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two inhaler medications (PT027 vs PT007) for Chinese adults with symptomatic asthma to see which is more effective and safer at controlling asthma symptoms. **You may be eligible if...** - You have been diagnosed with asthma by a doctor for at least 12 months - You have been on a stable asthma maintenance therapy for at least 3 months - Your asthma control questionnaire score shows your symptoms are not well controlled - You have had at least one severe asthma attack in the past 12 months - Your lung function test shows moderate impairment (FEV1 40-90% predicted) **You may NOT be eligible if...** - Your asthma is well controlled - You have COPD or another major lung condition - You recently had a serious asthma attack requiring hospitalization - You smoke or recently quit - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTBudesonide/Albuterol metered dose inhaler, MDI

Combination Product (Drug + Device)

COMBINATION_PRODUCTAlbuterol sulfate metered dose inhaler, MDI

Combination Product (Drug + Device)

Locations(102)

Research Site

Baotou, China

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Baotou, China

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Beijing, China

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Beijing, China

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Beijing, China

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Beijing, China

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Changchun, China

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Changchun, China

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Changsha, China

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Changsha, China

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Chengdu, China

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Chengdu, China

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Chengdu, China

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Chengdu, China

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Chengdu, China

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Chizhou, China

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Chongqing, China

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Chongqing, China

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Chongqing, China

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Dazhou, China

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Deyang, China

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Ganzhou, China

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Guangyuan, China

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Guangzhou, China

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Guangzhou, China

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Guangzhou, China

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Guangzhou, China

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Guangzhou, China

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Guangzhou, China

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Haikou, China

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Hangzhou, China

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Hangzhou, China

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Hefei, China

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Hefei, China

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Hefei, China

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Heifei, China

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Hohhot, China

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Hohhot, China

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Huizhou, China

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Huizhou, China

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Jinan, China

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Jinhua, China

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Jining, China

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Kunming, China

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Lanzhou, China

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Linhai, China

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Luoyang, China

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Luzhou, China

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Luzhou, China

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Mianyang, China

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Nanchang, China

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Nanchong, China

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Nanjing, China

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Nanjing, China

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Nantong, China

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Ningbo, China

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Panjin, China

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Panzhihua, China

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Pingxiang, China

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Qingdao, China

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Rui’an, China

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Sanya, China

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Shanghai, China

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Shanghai, China

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Shanghai, China

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Shenyang, China

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Shenyang, China

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Shenzhen, China

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Shenzhen, China

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Shijiazhuang, China

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Shijiazhuang, China

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Suining, China

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Taiyuan, China

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Taiyuan, China

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Tianjin, China

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Ürümqi, China

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Wenzhou, China

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Wenzhou, China

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Wuhan, China

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Wuhan, China

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Wuhu, China

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Xi'an, China

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Xiamen, China

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Xintai, China

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Xinxiang, China

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Xuzhou, China

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Xuzhou, China

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Yangzhou, China

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Yibin, China

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Yinchuan, China

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Yinchuan, China

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Yueyang, China

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Yuhuan, China

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Zhangzhou, China

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Zhengzhou, China

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Zhengzhou, China

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Zhuhai, China

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Zhuji, China

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Zibo, China

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Zigong, China

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Zunyi, China

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Hong Kong, Hong Kong

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