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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QR052107B 100 mg QD | Active Comparator | Participants will be treated with one tablet of QR052107B 100mg, three tablets of placebo once daily for up to 9 days. |
|
| QR052107B 400 mg QD | Active Comparator | Participants will be treated with four tablets of QR052107B 100mg once daily for up to 9 days. |
|
| placebo QD | Placebo Comparator | Participants will be treated with four tablets of placebo once daily for up to 9 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QR052107B 100 mg | Drug | QR052107B 100 mg QD |
| |
| QR052107B 400 mg |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ting Yang, MD | China-Japan Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| D003371 | Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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Eligible subjects were randomized at a ratio of 1:1:1 into QR052107B 100 mg QD, QR052107B 400 mg QD and placebo groups and then entered the administration and observation period.
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The treatment assignment during the the administration and observation period will be kept blinded to participants, investigators, care providers, and outcome assessors if applicable.
| Drug |
QR052107B 400 mg QD |
|
| Placebo | Drug | placebo QD |
|
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. |
| 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. | 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. | 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. | Baseline and day 4 |
| Change from baseline in cough severity VAS score on D4 and D10 | The changes in cough severity VAS score on D4 and D10 relative to baseline. | 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. | 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. | Baseline, day 4 and day10 |
| D013568 | Pathological Conditions, Signs and Symptoms |