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

RecruitingPhase 3Ages 18 Years - anyAllAstraZeneca
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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 โ‰ฅ 1.5 assessed at Visit 1 7. ACQ-5 score โ‰ฅ 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 โ‰ฅ 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
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What it tests

  • Budesonide/Albuterol metered dose inhaler, MDI
  • Albuterol sulfate metered dose inhaler, MDI
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Where

102 sites
Research Site
Baotou, China
Research Site
Baotou, China
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Changchun, China
Research Site
Changchun, China

โ€ฆand 94 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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