The purpose of the study is to Evaluate the Efficacy and Safety of QR052107B 100mg, QR052107B 400mg in Patients with Subacute Cough.
This study adopted a multicenter, randomized, parallel-group, double-blind and placebo-controlled design, and it was planned to enroll 270 patients with subacute cough following respiratory tract infection. After a screening period of 1-4 days, eligible subjects were randomized to the QR052107B 100 mg QD group, QR052107B 400 mg QD group and placebo group at a ratio of 1:1:1. The efficacy of QR052107B Tablets in the treatment of subacute cough was evaluated after 9 consecutive days of dosing. This study is divided into 3 stages: screening period, administration and observation period, and safety follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
270
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
GMR of mean coughs per hour within 24 hours on D10 versus baseline
The geometric mean ratio (GMR) of mean coughs per hour within 24 hours on day10 versus baseline.
Time frame: Baseline and day 10
GMR of mean coughs per hour within 24 h on D10 versus baseline in patients of ≥ 20 coughs per hour within 24 h at baseline
The geometric mean ratio of mean coughs per hour within 24 hours on day10 versus baseline in patients of ≥ 20 coughs per hour within 24 h at baseline.
Time frame: Baseline and day 10
GMR of mean coughs per hour within 24 h on D4 versus baseline in patients of ≥ 20 coughs per hour within 24 h at baseline
The geometric mean ratio of mean coughs per hour within 24 hours on day 4 versus baseline in patients of ≥ 20 coughs per hour within 24 h at baseline.
Time frame: Baseline and day 4
GMR of mean coughs per hour within 24 hours on D4 versus baseline
The geometric mean ratio of mean coughs per hour within 24 hours on day 4 versus baseline.
Time frame: Baseline and day 4
GMR of mean awake coughs per hour on D10 versus baseline
The geometric mean ratio of mean awake coughs per hour on day 10 versus baseline.
Time frame: Baseline and day 10
GMR of mean awake coughs per hour on D4 versus baseline
The geometric mean ratio of mean awake coughs per hour on day 4 versus baseline.
Time frame: Baseline and day 4
Change from baseline in cough severity VAS score on D4 and D10
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The changes in cough severity VAS score on D4 and D10 relative to baseline.
Time frame: Baseline, day 4 and day10
Change from baseline in LCQ-acute score on D4 and D10
The changes in LCQ-acute score on D4 and D10 relative to baseline.
Time frame: Baseline, day 4 and day10
Change from baseline in sleep VAS score on D4 and D10
The changes in sleep VAS score on D4 and D10 relative to baseline.
Time frame: Baseline, day 4 and day10