Clinical trial NCT06471257: A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Chinese asthma population
PT027
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-06-24
Enrollment: 790
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 790 participants who meet the eligibility criteria will be randomized.

The study will consist of 3 periods:

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

790 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

Eligibility 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

Primary outcomes:
measure: Time to first severe asthma exacerbation
timeFrame: 24 to 52 weeks
Secondary outcomes:
measure: Severe asthma exacerbation rate (annualized)
timeFrame: 24 to 52 weeks
measure: Total SCS exposure over the treatment period
timeFrame: 24 to 52 weeks
measure: ACQ-5 responder (≥ 0.5 decrease)
timeFrame: Week 24
measure: AQLQ+12 responder (≥ 0.5 increase)
timeFrame: Week 24
Other outcomes:
Locations:
city: Baotou
country: China
facility: Research Site
city: Baotou
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Changchun
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Chuangchun
country: China
facility: Research Site
city: Dazhou
country: China
facility: Research Site
city: Deyang
country: China
facility: Research Site
city: Ganzhou
country: China
facility: Research Site
city: Guangyuan
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Haikou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Hefei
country: China
facility: Research Site
city: Hefei
country: China
facility: Research Site
city: Hefei
country: China
facility: Research Site
city: Heifei
country: China
facility: Research Site
city: Hohhot
country: China
facility: Research Site
city: Huhehaote
country: China
facility: Research Site
city: Huizhou
country: China
facility: Research Site
city: Huizhou
country: China
facility: Research Site
city: Jinan
country: China
facility: Research Site
city: Jinhua
country: China
facility: Research Site
city: Jining
country: China
facility: Research Site
city: Kunming
country: China
facility: Research Site
city: Lanzhou
country: China
facility: Research Site
city: Linhai
country: China
facility: Research Site
city: Luoyang
country: China
facility: Research Site
city: Luzhou
country: China
facility: Research Site
city: Mianyang
country: China
facility: Research Site
city: Nan Chong
country: China
facility: Research Site
city: Nanchang
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Nantong
country: China
facility: Research Site
city: Ningbo
country: China
facility: Research Site
city: Panjin
country: China
facility: Research Site
city: Panzhihua
country: China
facility: Research Site
city: Pingxiang
country: China
facility: Research Site
city: Qingdao
country: China
facility: Research Site
city: Rui'an
country: China
facility: Research Site
city: Sanya
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Shenzhen
country: China
facility: Research Site
city: Shenzhen
country: China
facility: Research Site
city: Shijiazhuang
country: China
facility: Research Site
city: Shijiazhuang
country: China
facility: Research Site
city: Suining
country: China
facility: Research Site
city: Taiyuan
country: China
facility: Research Site
city: Taiyuan
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Urumqi
country: China
facility: Research Site
city: Wenzhou
country: China
facility: Research Site
city: Wenzhou
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Wuhu
country: China
facility: Research Site
city: Xi'an
country: China
facility: Research Site
city: Xiamen
country: China
facility: Research Site
city: Xintai
country: China
facility: Research Site
city: Xinxiang
country: China
facility: Research Site
city: Xuzhou
country: China
facility: Research Site
city: Xuzhou
country: China
facility: Research Site
city: Yangzhou
country: China
facility: Research Site
city: Yibin
country: China
facility: Research Site
city: Yinchuan
country: China
facility: Research Site
city: Yinchuan
country: China
facility: Research Site
city: Yueyang
country: China
facility: Research Site
city: Yuhuan
country: China
facility: Research Site
city: Zhengzhou
country: China
facility: Research Site
city: Zhengzhou
country: China
facility: Research Site
city: Zhuhai
country: China
facility: Research Site
city: Zhuji
country: China
facility: Research Site
city: Zibo
country: China
facility: Research Site
city: Zigong
country: China
facility: Research Site
city: Zunyi
country: China
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
Study officials:
References: