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

Recruiting now · Phase 3

Conditions studied: Asthma

In brief

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.

Key facts

Study ID: NCT06471257
Run by: AstraZeneca
People needed: 1000
Starts: 2024-06-17
Expected to finish: 2027-10-04
Last updated by the study team: 2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

Research Site — Guangzhou, China (enrolling)
Research Site — Guangzhou, China (enrolling)
Research Site — Baotou, China (enrolling)
Research Site — Beijing, China (enrolling)
Research Site — Baotou, China (enrolling)
Research Site — Changchun, China (enrolling)
Research Site — Changchun, China (enrolling)
Research Site — Beijing, China (enrolling)
Research Site — Changsha, China (enrolling)
Research Site — Chengdu, China (enrolling)
Research Site — Beijing, China (enrolling)
Research Site — Chengdu, China (enrolling)
Research Site — Chengdu, China (enrolling)
Research Site — Chengdu, China (enrolling)
Research Site — Chizhou, China (enrolling)
Research Site — Chongqing, China (enrolling)
Research Site — Chongqing, China (enrolling)
Research Site — Changsha, China (enrolling)
Research Site — Dazhou, China (enrolling)
Research Site — Deyang, China (enrolling)
Research Site — Ganzhou, China (enrolling)
Research Site — Guangyuan, China (enrolling)
Research Site — Chengdu, China (enrolling)
Research Site — Guangzhou, China (enrolling)
Research Site — Guangzhou, China (enrolling)

Full record on ClinicalTrials.gov

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