Asthma
Conditions
Interventions
B Group :Sequence 1: Treatment Period 1 (BDA MDI HFO) ? Treatment Period 2 (BDA MDI HFA) ? Treatment Period 3 (Placebo MDI HFA)
Sequence 2: Treatment Period 1 (BDA MDI HFO) ? Treatment Period 2 (Place
A1 Group :Sequence 1: Treatment period 1 (BDA MDI HFO) ? Treatment period 2 (BDA MDI HFA) ? Treatment period 3 (BDA MDI HFO)
Sequence 2: Treatment period 1 (BDA MDI HFO) ? Treatment period 2 (BDA MDI
A2 Group :Sequence 1: Treatment period 1 (BDA MDI HFA) ? Treatment period 2 (BDA MDI HFO) ? Treatment period 3 (BDA MDI HFA)
Sequence 2: Treatment period 1 (BDA MDI HFA) ? Treatment period 2 (BDA MDI
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Participant must be >= 18 years of age at the time of signing the ICF. 2. Participants who have physician diagnosed asthma as defined by GINA (GINA, 2023) for at least 12 months prior to Visit 1. 3. Eligible participants are on either a) no daily inhaled maintenance therapy or b) daily inhaled maintenance therapy with low-dose ICS or low-dose ICS-LABA (see Table 5). Participants who are on low-dose ICS maintenance therapy are required to be stable on therapy for a minimum of 3 months prior to Visit 1; participants using low-dose ICS-LABA maintenance regimens are required to be stable on therapy for a minimum of 6 months prior to Visit 1. 4. Participants with a pre-bronchodilator FEV1 of >= 60% and = 60% and 12% and > 200 mL increase in FEV1 relative to baseline following administration of study-provided SABA at Visit 1 or Visit 1a (GINA, 2023, Pellegrino et al, 2005). 7.Participants able to demonstrate acceptable spirometry performance as defined by the acceptability and repeatability criteria in the ATS/ERS Standardization of Spirometry 2019 update (Graham et al, 2019). 8.Participants who are willing and, in the opinion of the investigator, able to adjust current asthma therapy, as required by the protocol. 9.Participants with a body mass index = 50 years old would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment.*Female participants of childbearing potential must use one highly effective form of birth control. A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. Females of childbearing potential who are sexually active with a non-sterilized male partner must agree to use one highly effective method of birth control, as defined below, from enrollment throughout the study and until at least 14 days after last dose of study intervention. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female condom and male condom should not be used together.*All females of childbearing potential must have a negative serum pregnancy test result at Visit 1.*Females < 50 years o
Exclusion criteria
Exclusion criteria: 1.Confirmed or suspected diagnosis of COPD or clinically significant non-asthma airway/lung disease. 2.Systemic corticosteroid use (eg, prednisone for 3 or more days or a single depo-injectable dose of corticosteroids) for any respiratory, immune, or allergy-attributed disease within 6 months prior to Visit 1. 3.An upper respiratory infection requiring antibiotic treatment that is not resolved within 7 days prior to Visit 1. 4.A lower respiratory infection in the 4 weeks prior to Visit 1. 5.Life-threatening asthma defined as any history of significant asthma episode(s) requiring admission to an intensive care unit, positive pressure ventilation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) within 5 years of Visit 1. 6.Hospitalization due to asthma within 12 months or systemic corticosteroid usage (eg, prednisone for 3 or more days or a single depo-injectable dose of corticosteroids) for asthma within 6 months prior to Visit 1. 7.A severe asthma exacerbation during the run-in period (see Section 8.3.5.3). 8.An ePRO device alert during the run-in period with investigator-confirmed worsening asthma symptoms (see Section 8.3.5.2). 9.Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (eg, congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia, coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (eg, uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison’s disease, Cushing’s syndrome), or gastrointestinal (eg, poorly controlled peptic ulcer, gastroesophageal reflux disease) disorders. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the participant at risk through study participation or that could affect the efficacy or safety analyses if the disease/condition exacerbated during the study. 10.Unresectable cancer that has not been in complete remission for at least 5 years prior to Visit 1.Note: Squamous cell and basal cell carcinomas of the skin are allowed if, in the opinion of the investigator, the condition has been clinically controlled and the participant’s inclusion in the study does not represent a safety concern. 11.Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1. 12.Known history of drug or alcohol abuse within 12 months of Visit 1 or known abuse at any time during the study. 13.Not considered likely to be able to abstain from reliever use within 6 hours prior to lung function testing at each study visit. 14.Chronic use of systemic corticosteroid for asthma, defined as = 2 weeks, within 12 months prior to Visit 1. 15.Unable to abstain from any protocol-defined prohibited medications during the run-in or treatment periods (see Section 6.9). 16.Use of herbal products by either inhalation or nebulizer or oral herbal products (containing glucocorticoid-like activity) within 2 weeks prior to Visit 1 or refusal to stop use for the duration of the study. 17.Participation in another clinical study with a study intervention administered or device within 30 days or 5 half-lives, whichever is longer, prior to Visit 1. 18.Participants with a known hypersensitivity to albuterol or budesonide and/or excipients of BDA and/or HFA/HFO propellants. 19.Participants with ECG QTcF interval > 480 msec. 20.Any clinically relevant abnormal fin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in peak FEV1 from baseline measured from 0-60 minutes after dosing on Day 29; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in morning pre-dose trough FEV1 on Day 29;Adverse event; | — |
Countries
China
Contacts
Public ContactZhang Min
Shanghai General Hospital
Outcome results
None listed