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

Korábbi kezelés

• 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
• Upper respiratory infection involving antibiotic treatment not resolved within 7 days before Visit 1
• Inability to abstain from protocol-defined prohibited medications during the study
• Having received a live attenuated vaccination within 7 days of Visit 1

Más betegség

• Chronic obstructive pulmonary disease or other significant lung disease
• 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
• 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

Laborértékek

• Clinically significant laboratory abnormalities

Egyéb

• Currently pregnant or breastfeeding
• Participants who experience > 1 asthma exacerbation during the screening period

• 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