AsthmaPhase 3BAIYUNNCT06471257

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma

A Phase 3 study testing Budesonide/Albuterol metered dose inhaler, MDI and Albuterol sulfate metered dose inhaler, MDI in people with Asthma, run by AstraZeneca at 102 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma
What is being tested?: Budesonide/Albuterol metered dose inhaler, MDI and Albuterol sulfate metered dose inhaler, MDI
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,000 participants
Where: 102 sitesin 2 countries
Study dates: 17 Jun 2024to 4 Oct 2027
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

Show all 17Show fewer

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
Currently pregnant or breastfeeding
Participants who experience > 1 asthma exacerbation during the screening period

Trial locations and contacts

102 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

Country

City, postcode or hospital

Sites recruiting now only

102 sites in 2 countries

China101 sites, 83 recruiting

Research Site
Baotou, 014010
Recruiting
Research Site
Baotou, 14010
Recruiting
Research Site
Beijing, 100020
Active, not recruiting
Research Site
Beijing, 100029
Recruiting
Research Site
Beijing, 100039
Recruiting
Research Site
Beijing, 100191
Recruiting
Research Site
Changchun, 130021
Recruiting
Research Site
Changchun, 130041
Recruiting
Research Site
Changsha, 410005
Recruiting
Research Site
Changsha, 410015
Recruiting
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Chengdu, 610000
Recruiting
Research Site
Chengdu, 610021
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Research Site
Chengdu, 610041
Recruiting
Research Site
Chengdu, 610072
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Chengdu, 610500
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Chizhou, 247099
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Chongqing, 400010
Recruiting
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Chongqing, 400037
Recruiting
Research Site
Chongqing, 401320
Completed
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Dazhou, 635000
Recruiting
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Deyang, 618000
Recruiting
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Ganzhou, 341099
Recruiting
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Guangyuan, 628000
Recruiting
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Guangzhou, 510000
Active, not recruiting
Research Site
Guangzhou, 510080
Recruiting
Research Site
Guangzhou, 510080
Completed
Research Site
Guangzhou, 510145
Recruiting
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Guangzhou, 510163
Recruiting
Research Site
Guangzhou, 510317
Recruiting
Research Site
Haikou, 570208
Active, not recruiting
Research Site
Hangzhou, 310006
Recruiting
Research Site
Hangzhou, 310009
Withdrawn
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Hefei, 133500
Recruiting
Research Site
Hefei, 230061
Recruiting
Research Site
Hefei, 230601
Recruiting
Research Site
Heifei, 230011
Withdrawn
Research Site
Hohhot, 010017
Recruiting
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Hohhot, 010050
Recruiting
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Huizhou, 516001
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Huizhou, 516002
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Jinan, 250001
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Jinhua
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Jining, 272029
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Kunming, 650032
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Lanzhou, 730000
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Linhai, 317000
Recruiting
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Luoyang, 471000
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Luzhou, 646000
Recruiting
Research Site
Luzhou, 646000
Withdrawn
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Mianyang, 621000
Recruiting
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Nanchang, 330006
Recruiting
Research Site
Nanchong, 637000
Recruiting
Research Site
Nanjing, 210009
Recruiting
Research Site
Nanjing, 210012
Recruiting
Research Site
Nantong, 226001
Withdrawn
Research Site
Ningbo, 315010
Withdrawn
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Panjin, 124009
Withdrawn
Research Site
Panzhihua, 617099
Recruiting
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Pingxiang, 337055
Recruiting
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Qingdao, 266011
Recruiting
Research Site
Rui’an, 325200
Recruiting
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Sanya, 572000
Withdrawn
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Shanghai, 200032
Recruiting
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Shanghai, 200080
Completed
Research Site
Shanghai, 201199
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Shenyang, 110004
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Shenyang, 110032
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Shenzhen, 518020
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Shenzhen, 518036
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Shijiazhuang, 054001
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Shijiazhuang, 50051
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Suining, 629000
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Taiyuan, 030001
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Taiyuan, 030032
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Tianjin, 300050
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Ürümqi, 830054
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Wenzhou, 325000
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Research Site
Wenzhou, 325027
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Wuhan, 430030
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Research Site
Wuhan, 430060
Active, not recruiting
Research Site
Wuhu, 241000
Withdrawn
Research Site
Xi'an, 710006
Recruiting
Research Site
Xiamen, 361003
Recruiting
Research Site
Xintai, 54031
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Research Site
Xinxiang, 453002
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Xuzhou, 221000
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Research Site
Xuzhou, 221009
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Yangzhou, 225003
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Research Site
Yibin, 610500
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Yinchuan, 750001
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Research Site
Yinchuan, 750004
Completed
Research Site
Yueyang, 414000
Withdrawn
Research Site
Yuhuan, 317600
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Research Site
Zhangzhou, 363000
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Zhengzhou, 450003
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Zhengzhou, 450052
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Zhuhai, 519000
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Research Site
Zhuji, 311899
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Research Site
Zibo, 255036
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Research Site
Zigong, 643000
Withdrawn
Research Site
Zunyi, 563100
Recruiting

Other trials in China

Hong Kong1 site

Research Site
Hong Kong, 999077
Active, not recruiting

Other trials in Hong Kong

About this study

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)

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.

Read the 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 1000 participants who meet the eligibility criteria will be randomized.

The study will consist of 3 periods:

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

1000 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

Conditions: Asthma
Being tested: Budesonide/Albuterol metered dose inhaler, MDI, Albuterol sulfate metered dose inhaler, MDI
Keywords: Asthma, Chinese asthma population, PT027
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Budesonide/Albuterol metered dose inhaler, MDICombination product
Also called PT027
Combination Product (Drug + Device)
Albuterol sulfate metered dose inhaler, MDICombination product
Also called PT007
Combination Product (Drug + Device)

Study groups in NCT06471257
Study group	Role	What they receive
BDA MDI	Experimental	BDA MDI 160/180 μg (administered as 2 actuations of BDA MDI 80/90 μg) Receives: Combination Product: Budesonide/Albuterol metered dose inhaler, MDI
AS MDI	Active comparator	AS MDI 180 μg (administered as 2 actuations of AS MDI 90 μg) Receives: Combination Product: Albuterol sulfate metered dose inhaler, MDI

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 24 to 52 weeks

Secondary outcomes (4)

Severe asthma exacerbation rate (annualized)
The efficacy of BDA MDI administered as needed compared with AS MDI on severe asthma exacerbations and SCS exposure
Measured: 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
Measured: 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
Measured: 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
Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jun 20244 Oct 2027

First posted24 Jun 2024
Study start17 Jun 2024
Primary completion4 Oct 2027 (estimated)
Study completion4 Oct 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06471257
Sponsor's protocol ID: D6935C00003
Acronym: BAIYUN
Status last verified: Sep 2026
First submitted: 29 May 2024
Last updated: 21 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Interested in taking part?

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
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RecruitingPhase 2
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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT06471257
Acronym / sponsor ID: BAIYUN / D6935C00003
Conditions: Asthma
Keywords: Asthma, Chinese asthma population, PT027
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 1,000 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 17 Jun 2024 (actual)
Primary completion: 4 Oct 2027 (estimated)
Study completion: 4 Oct 2027 (estimated)
First posted: 24 Jun 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

The study will consist of 3 periods:

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

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
BDA MDI	Experimental	Combination Product: Budesonide/Albuterol metered dose inhaler, MDIBDA MDI 160/180 μg (administered as 2 actuations of BDA MDI 80/90 μg)
AS MDI	Active comparator	Combination Product: Albuterol sulfate metered dose inhaler, MDIAS MDI 180 μg (administered as 2 actuations of AS MDI 90 μg)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Budesonide/Albuterol metered dose inhaler, MDIAlso: PT027Combination Product (Drug + Device)	Combination product	BDA MDI
Albuterol sulfate metered dose inhaler, MDIAlso: PT007Combination Product (Drug + Device)	Combination product	AS MDI

Primary outcome

Time to first severe asthma exacerbation
Time frame: 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.

4 secondary outcomes

Severe asthma exacerbation rate (annualized)
Time frame: 24 to 52 weeks
Total SCS exposure over the treatment period
Time frame: 24 to 52 weeks
ACQ-5 responder (≥ 0.5 decrease)
Time frame: Week 24
AQLQ+12 responder (≥ 0.5 increase)
Time frame: Week 24

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
Individual participant dataSharing planned: Yes. 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.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

102 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Budesonide/Albuterol metered dose inhaler, MDI and Albuterol sulfate metered dose inhaler, MDI in people with Asthma, run by AstraZeneca at 102 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in China, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first severe asthma exacerbation (time frame: 24 to 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06471257.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.