The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma.
The total duration of study per patient is approximately 66 weeks, including 6 weeks of screening period, 52 weeks of treatment period and 8 weeks of follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
480
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGAnnualized rate of severe exacerbation events
Annualized rate of severe exacerbation events during the 52-week placebo-controlled treatment period
Time frame: Up to 52 weeks
Time to first severe exacerbation event
Time to first severe exacerbation event during the 52-week placebo-controlled treatment period
Time frame: Up to 52 weeks
Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit
Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit during the 52-week placebo-controlled treatment period
Time frame: Up to 52 weeks
Change from baseline in ACQ score
Change from baseline to week 52 in ACQ score
Time frame: Up to 52 weeks
Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ)
Change from baseline to week 52 in SGRQ score
Time frame: Up to 52 weeks
Change in pre-bronchodilator forced expiratory volume (FEV1)
Absolute change from baseline to week 52 in pre-bronchodilator FEV1
Time frame: Up to 52 weeks
Assessment of adverse events (AEs)
Number of participants with adverse events (AEs)
Time frame: Up to 60 weeks
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