A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma
NCT ID: NCT06471257
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
790 participants
INTERVENTIONAL
2024-06-17
2026-10-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BDA MDI
BDA MDI 160/180 μg (administered as 2 actuations of BDA MDI 80/90 μg)
Budesonide/Albuterol metered dose inhaler, MDI
Combination Product (Drug + Device)
AS MDI
AS MDI 180 μg (administered as 2 actuations of AS MDI 90 μg)
Albuterol sulfate metered dose inhaler, MDI
Combination Product (Drug + Device)
Interventions
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Budesonide/Albuterol metered dose inhaler, MDI
Combination Product (Drug + Device)
Albuterol sulfate metered dose inhaler, MDI
Combination Product (Drug + Device)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Baotou, , China
Research Site
Baotou, , China
Research Site
Beijing, , China
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Changchun, , China
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Changchun, , China
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Changsha, , China
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Changsha, , China
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Chengdu, , China
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Chengdu, , China
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Chengdu, , China
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Chengdu, , China
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Chengdu, , China
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Chizhou, , China
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Chongqing, , China
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Chongqing, , China
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Chongqing, , China
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Dazhou, , China
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Deyang, , China
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Ganzhou, , China
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Guangyuan, , China
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Guangzhou, , China
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Guangzhou, , China
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Guangzhou, , China
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Guangzhou, , China
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Guangzhou, , China
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Haikou, , China
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Hangzhou, , China
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Hangzhou, , China
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Hefei, , China
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Hefei, , China
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Hefei, , China
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Heifei, , China
Research Site
Hohhot, , China
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Hohhot, , China
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Huizhou, , China
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Huizhou, , China
Research Site
Jinan, , China
Research Site
Jinhua, , China
Research Site
Jining, , China
Research Site
Kunming, , China
Research Site
Lanzhou, , China
Research Site
Linhai, , China
Research Site
Luoyang, , China
Research Site
Luzhou, , China
Research Site
Luzhou, , China
Research Site
Mianyang, , China
Research Site
Nanchang, , China
Research Site
Nanchong, , China
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Nanjing, , China
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Nanjing, , China
Research Site
Nantong, , China
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Ningbo, , China
Research Site
Panjin, , China
Research Site
Panzhihua, , China
Research Site
Pingxiang, , China
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Qingdao, , China
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Rui’an, , China
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Sanya, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Shenyang, , China
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Shenyang, , China
Research Site
Shenzhen, , China
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Shenzhen, , China
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Shijiazhuang, , China
Research Site
Shijiazhuang, , China
Research Site
Suining, , China
Research Site
Taiyuan, , China
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Taiyuan, , China
Research Site
Tianjin, , China
Research Site
Ürümqi, , China
Research Site
Wenzhou, , China
Research Site
Wenzhou, , China
Research Site
Wuhan, , China
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Wuhan, , China
Research Site
Wuhu, , China
Research Site
Xi'an, , China
Research Site
Xiamen, , China
Research Site
Xintai, , China
Research Site
Xinxiang, , China
Research Site
Xuzhou, , China
Research Site
Xuzhou, , China
Research Site
Yangzhou, , China
Research Site
Yibin, , China
Research Site
Yinchuan, , China
Research Site
Yinchuan, , China
Research Site
Yueyang, , China
Research Site
Yuhuan, , China
Research Site
Zhangzhou, , China
Research Site
Zhengzhou, , China
Research Site
Zhengzhou, , China
Research Site
Zhuhai, , China
Research Site
Zhuji, , China
Research Site
Zibo, , China
Research Site
Zigong, , China
Research Site
Zunyi, , China
Research Site
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Other Identifiers
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D6935C00003
Identifier Type: -
Identifier Source: org_study_id
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