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Comparing two inhalers for asthma in Chinese adults

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)

Phase 3 Interventional AstraZeneca · NCT06471257

This study is testing whether a new inhaler that combines budesonide and albuterol works better for asthma symptoms in Chinese adults compared to a standard albuterol inhaler.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment790 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Locations102 sites (Baotou and 101 other locations)
Trial IDNCT06471257 on ClinicalTrials.gov

What this trial studies

This Phase III study evaluates the efficacy and safety of a budesonide and albuterol metered dose inhaler (MDI) compared to an albuterol sulfate MDI in symptomatic Chinese adults with asthma. The study is randomized, double-blind, and multicenter, involving approximately 790 participants who will be assigned to one of the two treatments. Participants will use the inhalers as needed in response to asthma symptoms or before exercise, with a treatment period lasting between 24 to 52 weeks. The study includes a screening period and a safety follow-up period after treatment.

Who should consider this trial

Good fit: Ideal candidates are symptomatic Chinese adults aged 18 and older with a documented history of asthma and recent severe exacerbations.

Not a fit: Patients with well-controlled asthma or those not meeting the eligibility criteria, such as those with FEV1 below 40% predicted, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective reliever therapy for asthma, potentially reducing the risk of severe exacerbations.

How similar studies have performed: Other studies have shown success with similar approaches in asthma management, indicating potential for positive outcomes in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Baotou and 101 other locations

+52 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions AsthmaChinese asthma populationPT027
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.