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)

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Combination product: Budesonide/Albuterol metered dose inhaler, MDI; Combination product: Albuterol sulfate metered dose inhaler, MDI

Detailed Description

This is a randomized, double-blind, multicenter, event-driven, parallel group, Phase III study to assess the efficacy and safety of budesonide and albuterol metered dose inhaler (MDI) versus albuterol sulfate (AS) MDI in symptomatic Chinese adults with asthma. Both treatments will be administered as needed in response to asthma symptoms or prior to exercise. Approximately 790 participants who meet the eligibility criteria will be randomized.

The study will consist of 3 periods:

1. Screening period: 14 to 28 days
2. Treatment period: minimum of 24 weeks and maximum of 52 weeks
3. Safety follow-up period: occur 2 weeks (± 4 days) after Visit 8, EOS or PDV, whichever occurs first

790 participants who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to receive one of the following 2 treatments to be used as reliever therapy on top of usual maintenance treatment:

• BDA MDI 160/180 μg (administered as 2 actuations of BDA MDI 80/90 µg) as needed
• AS MDI 180 μg (administered as 2 actuations of AS MDI 90 μg) as needed

• Study Type: Interventional
• Enrollment (Estimated): 790
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• China
  • Baotou, China, 14010
    • Recruiting
    • Research Site
  • Baotou, China, 014010
    • Recruiting
    • Research Site
  • Beijing, China, 100191
    • Recruiting
    • Research Site
  • Beijing, China, 100029
    • Recruiting
    • Research Site
  • Beijing, China, 100039
    • Recruiting
    • Research Site
  • Beijing, China, 100020
    • Active, not recruiting
    • Research Site
  • Changchun, China, 130021
    • Recruiting
    • Research Site
  • Changchun, China, 130041
    • Recruiting
    • Research Site
  • Changsha, China, 410005
    • Recruiting
    • Research Site
  • Changsha, China, 410015
    • Recruiting
    • Research Site
  • Chengdu, China, 610000
    • Recruiting
    • Research Site
  • Chengdu, China, 610041
    • Recruiting
    • Research Site
  • Chengdu, China, 610072
    • Recruiting
    • Research Site
  • Chengdu, China, 610021
    • Recruiting
    • Research Site
  • Chengdu, China, 610500
    • Recruiting
    • Research Site
  • Chizhou, China, 247099
    • Recruiting
    • Research Site
  • Chongqing, China, 400010
    • Recruiting
    • Research Site
  • Chongqing, China, 400037
    • Recruiting
    • Research Site
  • Chongqing, China, 401320
    • Suspended
    • Research Site
  • Dazhou, China, 635000
    • Recruiting
    • Research Site
  • Deyang, China, 618000
    • Recruiting
    • Research Site
  • Ganzhou, China, 341099
    • Recruiting
    • Research Site
  • Guangyuan, China, 628000
    • Recruiting
    • Research Site
  • Guangzhou, China, 510080
    • Recruiting
    • Research Site
  • Guangzhou, China, 510080
    • Active, not recruiting
    • Research Site
  • Guangzhou, China, 510000
    • Active, not recruiting
    • Research Site
  • Guangzhou, China, 510145
    • Recruiting
    • Research Site
  • Guangzhou, China, 510163
    • Recruiting
    • Research Site
  • Guangzhou, China, 510317
    • Recruiting
    • Research Site
  • Haikou, China, 570208
    • Suspended
    • Research Site
  • Hangzhou, China, 310006
    • Recruiting
    • Research Site
  • Hangzhou, China, 310009
    • Withdrawn
    • Research Site
  • Hefei, China, 133500
    • Recruiting
    • Research Site
  • Hefei, China, 230601
    • Recruiting
    • Research Site
  • Hefei, China, 230061
    • Recruiting
    • Research Site
  • Heifei, China, 230011
    • Withdrawn
    • Research Site
  • Hohhot, China, 010017
    • Recruiting
    • Research Site
  • Hohhot, China, 010050
    • Recruiting
    • Research Site
  • Huizhou, China, 516001
    • Recruiting
    • Research Site
  • Huizhou, China, 516002
    • Recruiting
    • Research Site
  • Jinan, China, 250001
    • Recruiting
    • Research Site
  • Jinhua, China
    • Recruiting
    • Research Site
  • Jining, China, 272029
    • Recruiting
    • Research Site
  • Kunming, China, 650032
    • Recruiting
    • Research Site
  • Lanzhou, China, 730000
    • Recruiting
    • Research Site
  • Linhai, China, 317000
    • Recruiting
    • Research Site
  • Luoyang, China, 471000
    • Recruiting
    • Research Site
  • Luzhou, China, 646000
    • Recruiting
    • Research Site
  • Luzhou, China, 646000
    • Withdrawn
    • Research Site
  • Mianyang, China, 621000
    • Recruiting
    • Research Site
  • Nanchang, China, 330006
    • Recruiting
    • Research Site
  • Nanchong, China, 637000
    • Recruiting
    • Research Site
  • Nanjing, China, 210009
    • Recruiting
    • Research Site
  • Nanjing, China, 210012
    • Recruiting
    • Research Site
  • Nantong, China, 226001
    • Withdrawn
    • Research Site
  • Ningbo, China, 315010
    • Withdrawn
    • Research Site
  • Panjin, China, 124009
    • Withdrawn
    • Research Site
  • Panzhihua, China, 617099
    • Recruiting
    • Research Site
  • Pingxiang, China, 337055
    • Recruiting
    • Research Site
  • Qingdao, China, 266011
    • Recruiting
    • Research Site
  • Rui’an, China, 325200
    • Recruiting
    • Research Site
  • Sanya, China, 572000
    • Withdrawn
    • Research Site
  • Shanghai, China, 200032
    • Recruiting
    • Research Site
  • Shanghai, China, 201199
    • Recruiting
    • Research Site
  • Shanghai, China, 200080
    • Completed
    • Research Site
  • Shenyang, China, 110004
    • Recruiting
    • Research Site
  • Shenyang, China, 110032
    • Recruiting
    • Research Site
  • Shenzhen, China, 518036
    • Recruiting
    • Research Site
  • Shenzhen, China, 518020
    • Recruiting
    • Research Site
  • Shijiazhuang, China, 50051
    • Recruiting
    • Research Site
  • Shijiazhuang, China, 054001
    • Recruiting
    • Research Site
  • Suining, China, 629000
    • Recruiting
    • Research Site
  • Taiyuan, China, 030001
    • Recruiting
    • Research Site
  • Taiyuan, China, 030032
    • Recruiting
    • Research Site
  • Tianjin, China, 300050
    • Recruiting
    • Research Site
  • Wenzhou, China, 325027
    • Recruiting
    • Research Site
  • Wenzhou, China, 325000
    • Recruiting
    • Research Site
  • Wuhan, China, 430030
    • Recruiting
    • Research Site
  • Wuhan, China, 430060
    • Recruiting
    • Research Site
  • Wuhu, China, 241000
    • Withdrawn
    • Research Site
  • Xi'an, China, 710006
    • Suspended
    • Research Site
  • Xiamen, China, 361003
    • Recruiting
    • Research Site
  • Xintai, China, 54031
    • Recruiting
    • Research Site
  • Xinxiang, China, 453002
    • Recruiting
    • Research Site
  • Xuzhou, China, 221000
    • Recruiting
    • Research Site
  • Xuzhou, China, 221009
    • Recruiting
    • Research Site
  • Yangzhou, China, 225003
    • Recruiting
    • Research Site
  • Yibin, China, 610500
    • Recruiting
    • Research Site
  • Yinchuan, China, 750001
    • Recruiting
    • Research Site
  • Yinchuan, China, 750004
    • Active, not recruiting
    • Research Site
  • Yueyang, China, 414000
    • Withdrawn
    • Research Site
  • Yuhuan, China, 317600
    • Recruiting
    • Research Site
  • Zhangzhou, China, 363099
    • Recruiting
    • Research Site
  • Zhengzhou, China, 450052
    • Recruiting
    • Research Site
  • Zhengzhou, China, 450003
    • Recruiting
    • Research Site
  • Zhuhai, China, 519000
    • Recruiting
    • Research Site
  • Zhuji, China, 311899
    • Recruiting
    • Research Site
  • Zibo, China, 255036
    • Recruiting
    • Research Site
  • Zigong, China, 643000
    • Withdrawn
    • Research Site
  • Zunyi, China, 563100
    • Recruiting
    • Research Site
  • Ürümqi, China, 830054
    • Recruiting
    • Research Site
• Hong Kong
  • Hong Kong, Hong Kong, 999077
    • Active, not recruiting
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Documented physician-diagnosed asthma for at least 12 months prior to Visit 1
2. Receiving 1 of the scheduled asthma maintenance therapies for 3 months with stable dosing for at least the last 4 weeks before Visit 1
3. Pre-bronchodilator FEV1 of ≥ 40% to < 90% predicted normal value for adults.
4. Documented reversibility to albuterol
5. A documented history of at least one severe asthma exacerbation within 12 months before Visit 1
6. ACQ-7 score ≥ 1.5 assessed at Visit 1
7. ACQ-5 score ≥ 1.5 assessed at Visit 2
8. Receiving inhaled SABA as needed prior to Visit 1 for at least 3 months
9. 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
10. Demonstrate acceptable MDI administration technique as assessed by the investigator; use of spacers is prohibited
11. Able to perform acceptable and reproducible PEF measurements as assessed by the investigator
12. BMI < 40 kg/m2
13. Negative pregnancy test (urine at Visit 1) for female participants of childbearing potential
14. Women of childbearing potential must agree to prevent pregnancy
15. Compliance: must be willing to remain at the study site as required per protocol and complete all visit assessments

Exclusion Criteria:

1. Chronic obstructive pulmonary disease or other significant lung disease
2. Oral/SCS use (any dose) within 6 weeks before Visit 1
3. Chronic use of OCS ≥ 3 weeks use in 3 months prior to Visit 1
4. 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
5. Current smokers, former smokers with > 10 pack-years history, or former smokers who stopped smoking < 6 months before Visit 1
6. 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
7. Completed treatment for lower respiratory infection or asthma exacerbation within 6 weeks of Visit 1
8. Upper respiratory infection involving antibiotic treatment not resolved within 7 days before Visit 1
9. Clinically significant laboratory abnormalities
10. Historical or current evidence of a clinically significant disease
11. Cancer not in complete remission for at least 5 years before Visit 1
12. History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions if their magnitude is limiting informed consent validity
13. Have a known or suspected hypersensitivity to albuterol/salbutamol, or budesonide and/or their excipients
14. Inability to abstain from protocol-defined prohibited medications during the study
15. Having received a live attenuated vaccination within 7 days of Visit 1
16. Currently pregnant or breastfeeding
17. Participants who experience > 1 asthma exacerbation during the screening period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BDA MDI; BDA MDI 160/180 μg (administered as 2 actuations of BDA MDI 80/90 μg)	Combination product: Budesonide/Albuterol metered dose inhaler, MDI; Combination Product (Drug + Device); Other Names: PT027
Active Comparator: AS MDI; AS MDI 180 μg (administered as 2 actuations of AS MDI 90 μg)	Combination product: Albuterol sulfate metered dose inhaler, MDI; Combination Product (Drug + Device); Other Names: PT007

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Asthma; PT027; Chinese asthma population
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Polycyclic Compounds; Pregnanes; Steroids; Fused-Ring Compounds; Pregnenediones; Pregnenes; Budesonide
• Other Study ID Numbers: D6935C00003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No