This is a phase II, randomised, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of HSK31858 in patients with airway mucus hypersecretion in chronic airway inflammatory diseases
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
309
Affiliated Beijing Chaoyang Hospital of Capital Medical University
Beijing, Beijing Municipality, China
Change from baseline in 24 hour sputum weight
Change from baseline in 24 hour sputum weight after 12 weeks of treatment
Time frame: 12-week treatment period
Change from baseline in expectoration difficulty score
Change from baseline in expectoration difficulty score after 4, 8 and 12 weeks of treatment.The expectoration difficulty score adopt a 4-level evaluation standard, 0 points for no expectoration, 1 points for easy expectoration, 2 points for moderate expectoration difficulty, and 3 points for hardest expectoration.
Time frame: 12-week treatment period
Change from baseline in sputum trait score
Change from baseline in sputum trait score after 4, 8, and 12 weeks of treatment.The sputum trait score was based on the Miller classification, according to the proportion of purulent part to total sputum volume.
Time frame: 12-week treatment period
Change from baseline in sputum viscosity score
Change from baseline in sputum viscosity score after 4, 8, and 12 weeks of treatment.The sputum viscosity score is based on a 5-level evaluation standard. Sputum adhering to the cup wall of the container and not sliding down is 1 point; sputum slowly sliding through the cup wall of the container under the action of gravity is 2 points; sputum sliding in large pieces through the cup wall under the action of gravity is 3 points; sputum is easily poured out and a small amount of thin mucus sticks to the cup wall of the container. No residual sputum on the wall of the container 5 points.
Time frame: 12-week treatment period
Change from baseline in cough severity score
Change from baseline in cough severity score after 4, 8, and 12 weeks of treatment.The visual analog scale (VAS) was used to score the severity of cough: a line 10 cm long was drawn on the white paper, and the corresponding scale was marked to indicate the severity of cough. The score was 0 to 10 points, 0 was no cough and no trouble to the patient, and 10 was the most serious cough and the most serious trouble to the patient.
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Time frame: 12-week treatment period
Change from baseline in cough and sputum assessment questionnaire
Change from baseline in cough and sputum assessment questionnaire after 4, 8, and 12 weeks of treatment.The cough and sputum assessment questionnaire is an evaluation tool used to evaluate the impact of cough and sputum on the quality of life of patients. The contents involved four dimensions: cough symptoms, cough effects, sputum symptoms and sputum effects. Each dimension contained different items, which were scored and statistically converted, with a total score of 100 points. The lower the score, the heavier airway mucus hypersecretion.
Time frame: 12-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 12 week.
Time frame: 12-week treatment period