This is a phase II, randomised, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of HSK31858 in patients with bronchial asthma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
219
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
The annualized asthma exacerbation rate within 24 weeks
Total number of acute exacerbations of bronchial asthma occurring within 24 weeks of study dosing / actual length of follow-up within 24 weeks of dosing
Time frame: 24-week treatment period
The annualized asthma exacerbation rate within 48 weeks
Total number of acute exacerbations of bronchial asthma occurring within 48 weeks of study dosing / actual length of follow-up within 48 weeks of dosing
Time frame: 48-week treatment period
Time to first acute exacerbation of bronchial asthma
Length of time from randomization to first acute exacerbation of bronchial asthma within 48 weeks of treatment
Time frame: 48-week treatment period
Change from Baseline in forced expiratory volume in 1 second (FEV1)
Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at each clinical visit during the treatment period
Time frame: 48-week treatment period
Change from baseline in peak expiratory flow(PEF)
Change from baseline in peak expiratory flow (PEF) at each clinical visit during the treatment period
Time frame: 48-week treatment period
Change from baseline in Asthma Control Test (ACT)
Change from baseline in Asthma Control Test (ACT) score at each clinical visit during the treatment period.The ACT score is a questionnaire designed to assess the level of asthma control, including the impact of asthma on daily life, number of breathlessness episodes, asthma symptoms, use of rescue medication, and self-assessment of asthma control. The ACT score is a questionnaire designed to assess the level of asthma control, including the impact of asthma on daily life, number of breathlessness episodes, asthma symptoms, use of rescue medication, and self-assessment of asthma control.
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Time frame: 48-week treatment period
Change from baseline in the 5-item Asthma Control Questionnaire (ACQ-5)
Change from baseline in the 5-item Asthma Control Questionnaire (ACQ-5) score at each clinical visit during the treatment period.5-item Asthma Control Questionnaire(ACQ-5) is a scoring scale used to assess asthma control in patients over the past week. It addresses asthma-related symptoms and consists of five items, each scored on a scale of 0 to 6, with higher scores indicating poorer control。Take the average score of 5 questions: \<0.75 points indicate that asthma has been fully controlled; a score between 0.75 and 1.5 indicates that asthma is well controlled; and a score of \>1.5 indicates that asthma is not controlled.
Time frame: 48-week treatment period
Change from baseline in 24-h sputum weight
Change from baseline in 24-h sputum weight at each clinical visit during the treatment period
Time frame: 48-week treatment period
The number of puffs of rescue medication used
The number of puffs of rescue medication used at each clinical visit during the treatment period
Time frame: 48-week treatment period
Change from baseline in Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ)
Change from baseline in Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) scores after 12, 24, 36, and 48 weeks of treatment.The Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) is dedicated to assessing the quality of daily life in adults with asthma. The Asthma Quality of Life Questionnaire is a 7-point scale, with 1 indicating the worst and 7 the best. The sum of each item scores is the total score. The maximum total score is 105, with higher scores indicating better asthma control and lower scores indicating poorer quality of life.
Time frame: 48-week treatment period
The proportion of patients without acute exacerbation of bronchial asthma
The proportion of patients without acute exacerbation of bronchial asthma after 24 and 48 weeks of treatment
Time frame: 48-week treatment period
Patient Global Impression of Change (PGIC)
Patient Global Impression of Change (PGIC) after 24 and 48 weeks of treatment.The PGIC scale is an assessment of the overall change in the patient's condition since the start of the study and is rated on a 7-point scale: a score of 1 represents extreme improvement, 2 represents significant improvement, 3 represents slight improvement, 4 represents no improvement, 5 represents slight deterioration, 6 represents significant deterioration and 7 represents critical deterioration.
Time frame: 48-week treatment period