RecruitingPhase 3NCT06471257
A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma
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)
Sponsor
AstraZeneca
Enrollment
790 participants
Start Date
Jun 17, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria15
- 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
Exclusion Criteria17
- 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
Interventions
COMBINATION_PRODUCTBudesonide/Albuterol metered dose inhaler, MDI
Combination Product (Drug + Device)
COMBINATION_PRODUCTAlbuterol sulfate metered dose inhaler, MDI
Combination Product (Drug + Device)
Locations(101)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06471257
Related Trials
A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
NCT06052267393 locations
A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma
NCT06664619138 locations
Genetic Association With Various Severities, Phenotypes and Endotypes of Asthma.
NCT061960342 locations
To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong
NCT046397911 location
Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma
NCT047069881 location