A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma
BAIYUN
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)
1 other identifier
interventional
790
2 countries
102
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Jun 2024
Typical duration for phase_3 asthma
102 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2024
CompletedStudy Start
First participant enrolled
June 17, 2024
CompletedFirst Posted
Study publicly available on registry
June 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 30, 2026
May 18, 2026
May 1, 2026
2.4 years
May 29, 2024
May 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Severe asthma exacerbation rate (annualized)
24 to 52 weeks
Total SCS exposure over the treatment period
24 to 52 weeks
ACQ-5 responder (≥ 0.5 decrease)
Week 24
AQLQ+12 responder (≥ 0.5 increase)
Week 24
Study Arms (2)
BDA MDI
EXPERIMENTALBDA MDI 160/180 μg (administered as 2 actuations of BDA MDI 80/90 μg)
AS MDI
ACTIVE COMPARATORAS MDI 180 μg (administered as 2 actuations of AS MDI 90 μg)
Interventions
Combination Product (Drug + Device)
Combination Product (Drug + Device)
Eligibility Criteria
You may qualify if:
- 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
- ACQ-5 score ≥ 1.5 assessed at Visit 2
- 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
You may not qualify if:
- Chronic obstructive pulmonary disease or other significant lung disease
- Oral/SCS use (any dose) within 6 weeks before Visit 1
- Chronic use of OCS ≥ 3 weeks use in 3 months prior to Visit 1
- Having received any marketed or investigational biologic within 3 months or 5 half-lives before Visit 1, whichever is longer, or any other prohibited medication
- Current smokers, former smokers with \> 10 pack-years history, or former smokers who stopped smoking \< 6 months before Visit 1
- Life-threatening asthma as defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s) within last 5 years of Visit 1
- Completed treatment for lower respiratory infection or asthma exacerbation within 6 weeks of Visit 1
- Upper respiratory infection involving antibiotic treatment not resolved within 7 days before Visit 1
- Clinically significant laboratory abnormalities
- Historical or current evidence of a clinically significant disease
- Cancer not in complete remission for at least 5 years before Visit 1
- History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions if their magnitude is limiting informed consent validity
- Have a known or suspected hypersensitivity to albuterol/salbutamol, or budesonide and/or their excipients
- Inability to abstain from protocol-defined prohibited medications during the study
- Having received a live attenuated vaccination within 7 days of Visit 1
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (102)
Research Site
Baotou, 014010, China
Research Site
Baotou, 14010, 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
Changchun, 130041, 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
Chizhou, 247099, China
Research Site
Chongqing, 400010, China
Research Site
Chongqing, 400037, China
Research Site
Chongqing, 401320, 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, 230061, China
Research Site
Hefei, 230601, China
Research Site
Heifei, 230011, China
Research Site
Hohhot, 010017, China
Research Site
Hohhot, 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, 317000, China
Research Site
Luoyang, 471000, China
Research Site
Luzhou, 646000, China
Research Site
Luzhou, 646000, China
Research Site
Mianyang, 621000, China
Research Site
Nanchang, 330006, China
Research Site
Nanchong, 637000, China
Research Site
Nanjing, 210009, China
Research Site
Nanjing, 210012, China
Research Site
Nantong, 226001, China
Research Site
Ningbo, 315010, China
Research Site
Panjin, 124009, 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
Shenyang, 110032, 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, 300050, China
Research Site
Ürümqi, 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
Zhangzhou, 363099, China
Research Site
Zhengzhou, 450003, China
Research Site
Zhengzhou, 450052, China
Research Site
Zhuhai, 519000, China
Research Site
Zhuji, 311899, China
Research Site
Zibo, 255036, China
Research Site
Zigong, 643000, China
Research Site
Zunyi, 563100, China
Research Site
Hong Kong, 999077, Hong Kong
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2024
First Posted
June 24, 2024
Study Start
June 17, 2024
Primary Completion (Estimated)
October 30, 2026
Study Completion (Estimated)
October 30, 2026
Last Updated
May 18, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.