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This is a phase 4, randomized, double-blind, multicenter clinical trial to evaluate the efficacy and safety of YMC026 in respiratory disease patients with cough and sputum as the main symptoms
The study has planned 4 visits during 2 weeks period (1 week of screening period, 1 week of treatment period). All subjects who agree to participate in the study and voluntarily give written informed consent are assessed by inclusion and exclusion criteria at the screening visit. After the screening period, the final eligibility of the subjects will be assessed at the randomization visit. Subjects who are determined to be appropriate for this study will be allocated to experimental group(YMC026) or control group(placebo) randomly in a 1:1 ratio. Subject will be administered the investigational product daily for 6 days. The safety for the subjects will be assessed at Day 3 and Day 6 visit, and the efficacy evaluation will be assessed at Day 6 visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YMC026 | Experimental | 108 subjects will be assigned in this group. They will be administered 20mL of YMC026 three times a day for 6 days. |
|
| Placebo | Placebo Comparator | 108 subjects will be assigned in this group. They will be administered 20mL of placebo three times a day for 6 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YMC026 | Drug | YMC026 20mL TID |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline BSS at Day 6 | Bronchitis Severity Score | Baseline(Day 0), Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline BCSS at Day 6 | Breathlessness, Cough, and Sputum Scale | Baseline(Day 0), Day 6 |
| Patients´ evaluation of symptoms of cough and sputum on patient's diary | Day 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea, Seoul St.Mary's Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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| Drug |
Placebo 20mL TID |
|