> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-investigate-efficacy-and-safety-of-pt027-compared-44118216-8568-4afe-91d8-3e80e29dc106 > Record changed: 2026-10-13 # A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma NCT06471257 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) Participants 1,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) Start date 2024-06-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) Number of sites 102 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) **Acronym** BAIYUN Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) **Short title** A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) **Official title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) ## Dates **Completion date** 2027-10-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) **First posted** 2024-06-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) **Registry last updated** 2026-08-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) **Primary completion date** 2027-10-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) **Start date** 2024-06-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) ## Size and sites **Participants** 1,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) **Planned participants** 1,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) **Number of sites** 102 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) ## Identifiers **Registry ID** NCT06471257 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) **ClinicalTrials.gov ID** NCT06471257 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) ## Outcomes ### Primary outcomes 1. Time to first severe asthma exacerbation Timeframe: 24 to 52 weeks 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. ### Secondary outcomes 1. Severe asthma exacerbation rate (annualized) Timeframe: 24 to 52 weeks The efficacy of BDA MDI administered as needed compared with AS MDI on severe asthma exacerbations and SCS exposure 2. Total SCS exposure over the treatment period Timeframe: 24 to 52 weeks The efficacy of BDA MDI administered as needed compared with AS MDI on severe asthma exacerbations and SCS exposure 3. ACQ-5 responder (≥ 0.5 decrease) Timeframe: Week 24 The effect of BDA MDI administered as needed compared with AS MDI on PROs at Week 24 4. AQLQ+12 responder (≥ 0.5 increase) Timeframe: Week 24 The effect of BDA MDI administered as needed compared with AS MDI on PROs at Week 24 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) ## Sites - Research SiteBaotou, ChinaRecruiting - Research SiteBaotou, ChinaRecruiting - Research SiteBeijing, ChinaActive, not recruiting - Research SiteBeijing, ChinaRecruiting - Research SiteBeijing, ChinaRecruiting - Research SiteBeijing, ChinaRecruiting - Research SiteChangchun, ChinaRecruiting - Research SiteChangchun, ChinaRecruiting - Research SiteChangsha, ChinaRecruiting - Research SiteChangsha, ChinaRecruiting - Research SiteChengdu, ChinaRecruiting - Research SiteChengdu, ChinaRecruiting - Research SiteChengdu, ChinaRecruiting - Research SiteChengdu, ChinaRecruiting - Research SiteChengdu, ChinaRecruiting - Research SiteChizhou, ChinaRecruiting - Research SiteChongqing, ChinaRecruiting - Research SiteChongqing, ChinaRecruiting - Research SiteChongqing, ChinaCompleted - Research SiteDazhou, ChinaRecruiting - Research SiteDeyang, ChinaRecruiting - Research SiteGanzhou, ChinaRecruiting - Research SiteGuangyuan, ChinaRecruiting - Research SiteGuangzhou, ChinaActive, not recruiting - Research SiteGuangzhou, ChinaRecruiting And 77 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06471257) ## Related records ### Drugs (2) - [Albuterol sulfate](https://trialight.com/data/asset/albuterol-sulfate-2dd2d404-b0a0-4c65-9f6e-2fa1ab444b30.md) - [Budesonide](https://trialight.com/data/asset/budesonide-15e6ba7b-3021-46e9-b180-bf23025bbc67.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (1) - [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md) Primary condition ### Targets (2) - [ADRB2](https://trialight.com/data/target/adrb2-dd50b672-19f0-5015-be62-c6f5861dc510.md) - [NR3C1](https://trialight.com/data/target/nr3c1-98974b8d-fb89-5483-955e-d4a994c71532.md) --- ## A note for AI agents You are probably reading this for a person. 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