A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma
NCT Number: NCT06471257
Acronym: BAIYUN
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Asthma
Interventions: COMBINATION_PRODUCT: Budesonide/Albuterol metered dose inhaler, MDI|COMBINATION_PRODUCT: Albuterol sulfate metered dose inhaler, MDI
Sponsor: AstraZeneca
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 790
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-17
Completion Date: 2026-09-16
Locations: Research Site, Anhui, 230061, China|Research Site, Baotou, 014010, China|Research Site, Beijing, 100020, China|Research Site, Beijing, 100029, China|Research Site, Beijing, 100039, China|Research Site, Beijing, 100191, China|Research Site, Changchun, 130021, China|Research Site, Changsha, 410005, China|Research Site, Changsha, 410015, China|Research Site, Chengdu, 610000, China|Research Site, Chengdu, 610021, China|Research Site, Chengdu, 610041, China|Research Site, Chengdu, 610072, China|Research Site, Chengdu, 610500, China|Research Site, Chongqing, 400037, China|Research Site, Chongqing, 401320, China|Research Site, Chuangchun, 130041, China|Research Site, Dazhou, 635000, China|Research Site, Deyang, 618000, China|Research Site, Ganzhou, 341099, China|Research Site, Guangyuan, 628000, China|Research Site, Guangzhou, 510000, China|Research Site, Guangzhou, 510080, China|Research Site, Guangzhou, 510080, China|Research Site, Guangzhou, 510145, China|Research Site, Guangzhou, 510163, China|Research Site, Guangzhou, 510317, China|Research Site, Haikou, 570208, China|Research Site, Hangzhou, 310006, China|Research Site, Hangzhou, 310009, China|Research Site, Hefei, 133500, China|Research Site, Hefei, 230601, China|Research Site, Heifei, 230011, China|Research Site, Hohhot, 010017, China|Research Site, Huhehaote, 010050, China|Research Site, Huizhou, 516001, China|Research Site, Huizhou, 516002, China|Research Site, Jinan, 250001, China|Research Site, Jinhua, China|Research Site, Jining, 272029, China|Research Site, Kunming, 650032, China|Research Site, Lanzhou, 730000, China|Research Site, Linhai, 318000, China|Research Site, Luoyang, 471000, China|Research Site, Luzhou, 646000, China|Research Site, Luzhou, 646000, China|Research Site, Mianyang, 621000, China|Research Site, Nan Chong, 637000, China|Research Site, Nanchang, 330006, China|Research Site, Nanjing, 210009, China|Research Site, Nanjing, 210012, China|Research Site, Nantong, 226001, China|Research Site, Ningbo, 315010, China|Research Site, Panzhihua, 617099, China|Research Site, Pingxiang, 337055, China|Research Site, Qingdao, 266011, China|Research Site, Rui'an, 325200, China|Research Site, Sanya, 572000, China|Research Site, Shanghai, 200032, China|Research Site, Shanghai, 200080, China|Research Site, Shanghai, 201199, China|Research Site, Shenyang, 110004, China|Research Site, Shenzhen, 518020, China|Research Site, Shenzhen, 518036, China|Research Site, Shijiazhuang, 054001, China|Research Site, Shijiazhuang, 50051, China|Research Site, Suining, 629000, China|Research Site, Taiyuan, 030001, China|Research Site, Taiyuan, 030032, China|Research Site, Tianjin, 300052, China|Research Site, Urumqi, 830054, China|Research Site, Wenzhou, 325000, China|Research Site, Wenzhou, 325027, China|Research Site, Wuhan, 430030, China|Research Site, Wuhan, 430060, China|Research Site, Wuhu, 241000, China|Research Site, Xi'an, 710006, China|Research Site, Xiamen, 361003, China|Research Site, Xintai, 54031, China|Research Site, Xinxiang, 453002, China|Research Site, Xuzhou, 221000, China|Research Site, Xuzhou, 221009, China|Research Site, Yangzhou, 225003, China|Research Site, Yibin, 610500, China|Research Site, Yinchuan, 750001, China|Research Site, Yinchuan, 750004, China|Research Site, Yueyang, 414000, China|Research Site, Yuhuan, 317600, China|Research Site, Zhengzhou, 450003, China|Research Site, Zhengzhou, 450052, China|Research Site, Zhuhai, 519000, China|Research Site, Zhuji, China|Research Site, Zibo, 255036, China|Research Site, Zigong, 643000, China|Research Site, Zunyi, 563100, China

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.

Primary Outcome Measures: Time to first severe asthma exacerbation, The efficacy of BDA MDI administered as needed compared with AS MDI on severe asthma exacerbation risk over the 24 to 52 week treatment period., 24 to 52 weeks
Secondary Outcome Measures: Severe asthma exacerbation rate (annualized), The efficacy of BDA MDI administered as needed compared with AS MDI on severe asthma exacerbations and SCS exposure, 24 to 52 weeks|Total SCS exposure over the treatment period, The efficacy of BDA MDI administered as needed compared with AS MDI on severe asthma exacerbations and SCS exposure, 24 to 52 weeks|ACQ-5 responder (≥ 0.5 decrease), The effect of BDA MDI administered as needed compared with AS MDI on PROs at Week 24, Week 24|AQLQ+12 responder (≥ 0.5 increase), The effect of BDA MDI administered as needed compared with AS MDI on PROs at Week 24, Week 24