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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
Time to first severe asthma exacerbation — 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.
Trial sites (102)
Facility
City
Region
Status
Research Site
Baotou
China
Recruiting
Research Site
Baotou
China
Recruiting
Research Site
Beijing
China
Active Not Recruiting
Research Site
Beijing
China
Recruiting
Research Site
Beijing
China
Recruiting
Research Site
Beijing
China
Recruiting
Research Site
Changchun
China
Recruiting
Research Site
Changchun
China
Recruiting
Research Site
Changsha
China
Recruiting
Research Site
Changsha
China
Recruiting
Research Site
Chengdu
China
Recruiting
Research Site
Chengdu
China
Recruiting
Research Site
Chengdu
China
Recruiting
Research Site
Chengdu
China
Recruiting
Research Site
Chengdu
China
Recruiting
Research Site
Chizhou
China
Recruiting
Research Site
Chongqing
China
Recruiting
Research Site
Chongqing
China
Recruiting
Research Site
Chongqing
China
Completed
Research Site
Dazhou
China
Recruiting
Research Site
Deyang
China
Recruiting
Research Site
Ganzhou
China
Recruiting
Research Site
Guangyuan
China
Recruiting
Research Site
Guangzhou
China
Active Not Recruiting
Research Site
Guangzhou
China
Recruiting
Research Site
Guangzhou
China
Completed
Research Site
Guangzhou
China
Recruiting
Research Site
Guangzhou
China
Recruiting
Research Site
Guangzhou
China
Recruiting
Research Site
Haikou
China
Active Not Recruiting
Research Site
Hangzhou
China
Recruiting
Research Site
Hangzhou
China
Withdrawn
Research Site
Hefei
China
Recruiting
Research Site
Hefei
China
Recruiting
Research Site
Hefei
China
Recruiting
Research Site
Heifei
China
Withdrawn
Research Site
Hohhot
China
Recruiting
Research Site
Hohhot
China
Recruiting
Research Site
Huizhou
China
Recruiting
Research Site
Huizhou
China
Recruiting
+ 62 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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