This study will assess the efficacy and safety of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 610 in adults with severe eosinophilic asthma. Plan to recruit 120 subjects, and the subjects divided into 3 groups: 610 100mg group, 610 300mg group and placebo group. The study is divided into screening period of 4 weeks, treatment period of 16 weeks and follow-up period of 8 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 16
FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry.
Time frame: Baseline (Day 1) and at week 16
Changes from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at weeks 4, 8, and 12
FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry.
Time frame: Baseline (Day 1) and at week 4,8,12
Percentage change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at weeks 4, 8, 12, 16
Percentage of FEV1 will be measured using spirometry.
Time frame: Baseline (Day 1) and at week 4,8,12
Number of asthma exacerbation through study week 16
Asthma exacerbation are defined as worsening of asthma which required use of systemic corticosteroids (≥3 days. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits.
Time frame: From baseline (Day 1) to week 16
Time to first asthma exacerbation event
Asthma exacerbation are defined as worsening of asthma which required use of systemic corticosteroids (≥3 days. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits.
Time frame: From baseline (Day 1) to week 16
Number of asthma exacerbations requiring hospitalization (including intubation and ICU admission) or emergency room visits (not conversion to hospitalization)
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Asthma exacerbations that are associated with a hospitalization or an emergency room visit.
Time frame: From baseline (Day 1) to week 16
Number of asthma exacerbations requiring hospitalization (including intubation and ICU admission)
Asthma exacerbations that are associated with a hospitalization.
Time frame: From baseline (Day 1) to week 16
Puffs of rescue medication for asthma exacerbations
Albuterol or levalbuterol for an asthma exacerbation is considered rescue medication.
Time frame: From baseline (Day 1) to week 16
Change from baseline in Asthma Control Questionnaire score at week 4,8,12,16
The ACQ has 7 questions- the first 5 items assess the most common asthma symptoms plus 6. short-acting bronchodilator use and 7. FEV1 (pre-bronchodilator use, % and % predicted use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6= maximum impairment).
Time frame: Baseline (Day 1) and at week 4,8,12,16
Change From Baseline in the St. George's Respiratory Questionnaire Total Score at week 16
The St. George's Respiratory Questionnaire is an established instrument, comprising 50 questions, evaluating symptoms, activity, and impacts; to measure Quality of Life in participants with diseases of airway obstruction and to elicit the participant's opinion of his/her health.
Time frame: Baseline (Day 1) and at week 16