Asthma
Conditions
Interventions
Control group:AS MDI 180 µg (administered as 2 actuations of AS MDI 90 µg) as needed
Test group:BDA MDI 160/180 µg (administered as 2 actuations of BDA MDI 80/90 µg) as needed
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1 Give their signed written ICF to participate prior to any study specific procedures 2 Female or male aged = 18 years at the time of ICF 3 Documented physician-diagnosed asthma for at least 12 months prior to Visit 1 4 Receiving 1 of the following scheduled asthma maintenance therapies for 3 months with stable dosing for at least the last 4 weeks before Visit 1: (a) Medium-to-high-dose ICS (Appendix A) (b) Medium-to-high-dose ICS and 1 additional maintenance therapy from the following: LTRA, LAMA, or theophylline (c) Low-to-high-dose ICS in combination with LABA with or without 1 additional maintenance therapy from the following: LTRA, LAMA, or theophylline (i) Up to 20% of all randomized participants (on ICS alone or ICS in combination with LABA) will be permitted to have an additional maintenance medication (theophylline, LTRA, or LAMA) The below defines the minimally acceptable documentation required to support inclusion criterion 4: Signed and dated notes from a referring physician, including name, dose, and duration of the ICS or ICS/LABA inhaler (or names and doses, if used as separate inhalers) and LTRA, LAMA, or theophylline, if applicable, and/or Evidence of prescriptions for an ICS, ICS/LABA, and LTRA, LAMA, or theophylline if applicable, medications that demonstrate coverage for the duration specified in inclusion criteria 5 Pre-bronchodilator FEV1 of = 40% to < 90% predicted normal value for adults. If FEV1 values are not within the permitted range at Visit 1, one re-test must be performed at Visit 1a before advancing to Visit 2 or confirming screen failure. 6 Documented reversibility to albuterol with an increase in FEV1 = 12% and 200 ml relative to baseline either in the 12 months prior to Visit 1 or after administration of Sponsor-provided salbutamol sulfate inhalation aerosol via non-central spirometry at Visit 1 (or 1a, with repeat at 1b if necessary). If reversibility is not documented nor demonstrated at Visit 1, 1 re-test for reversibility testing must be done at Visit 1a before advancing to Visit 2 for participants without documented historical reversibility or confirming screen failure. Note: Reversibility testing is still required at Visit 1/1a/1b, even if the participant has documented historical reversibility reported in the 12 months prior to Visit 1 (for baseline characterization). Participants who do not meet inclusion criteria 6 will be permitted to rescreen. Each participant may rescreen only once. 7 A documented history of at least one severe asthma exacerbation within 12 months before Visit 1 For inclusion, a severe exacerbation is considered to be any deterioration of asthma that led to at least 1 of the following conditions: (a) A temporary bolus/burst of SCS for at least 3 consecutive days to treat symptoms of asthma worsening; a single depo-injectable dose of corticosteroids will be considered equivalent to a 3-day bolus/burst of SCS (b) An emergency room or urgent care visit (defined as evaluation and treatment for < 24 hours in an emergency department or urgent care center) due to asthma that required SCS (as per the above) (c) An in-patient hospitalization (defined as admission to an in-patient facility and/or evaluation and treatment in a healthcare facility for = 24 hours) due to asthma The below defines what is acceptable to document exacerbations for inclusion in this study: Discharge summaries from a hospital, emergency room, or an urgent care facility indicating that a particip
Exclusion criteria
Exclusion criteria: 1 Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia), including regular or occasional use of oxygen 2 Oral/SCS use (any dose) within 6 weeks before Visit 1 Participants who have experienced an asthma exacerbation requiring oral/systemic glucocorticosteroid in the 6 weeks before Visit 1 cannot be enrolled in the study because of the 6 weeks wash out of the oral/SCS, but can enter Visit 1 once the wash out period has been met Note: Participants who fail due to exclusion criteria 2 will be permitted to rescreen. Each participant may rescreen only once. 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 1.5 times the upper limit of the reference range (b) serum TBL > 1.5 times the upper limit of the reference range (c) serum ALT or AST value > 2.5 times the upper limit of the reference range Note: Laboratory tests may be repeated once: if laboratory tests have to be repeated, the results must be available for review before Visit 2 (randomization). 10 Having any of the following results at Visit 1: (a) an abnormal ECG that is, in the investigator’s opinion, clinically significant (b) QTCF interval > 480 ms based on the Fridericia correction where QTCF=QT/RR 0.33) 11 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 analysis if the disease/condition exacerbated during the study. 12 Cancer not in complete remission for at least 5 years before Visit 1 Note: Participants with squamous cell carcinoma of the skin, basal cell carcinoma of t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first severe asthma exacerbation;Salbutamol reversibility test;Lung function test (FEV1); | — |
Secondary
| Measure | Time frame |
|---|---|
| Severe asthma exacerbation rate a (annualized);ACQ-5 responders (decline = 0.5) at Week 24;Respondents to the Asthma Quality of Life Questionnaire (decline = 0.5) at week 24; | — |
Countries
China
Contacts
Public ContactWeimin Li; Gang Wang
West China Hospital of Sichuan University
Outcome results
None listed