A Clinical Trial to Evaluate the Efficacy and Safety of YMC026 in Respiratory Disease Patients

Yuhan

Status and phase: Completed; Phase 4

Conditions: Respiratory Disease

Treatments: Drug: YMC026; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03334916

YMC026

Details and patient eligibility

About

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

Full description

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.

Enrollment: 223 patients

Sex: All

Ages: 15 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Both gender, 15 years ≤ age < 75 years
2. Patients with BSS(Bronchitis Severity Score) ≥ 5point at screening visit and randomization visit
3. Written consent voluntarily to participate in this clinical trial

Exclusion criteria

1. Patients with severe respiratory disease
2. Patients with severe pulmonary disease
3. Patients who has history for drug hypersensitivity or allergic reaction in component of investigational product or similar drug
4. Patients with pregnant and/or have breast feeding
5. Patients who were treated with monoamine oxidase inhibitor, antihistamines, anti-viral drugs and glucocorticoids within 2 weeks prior to administration of investigational product
6. Patients who were treated with β2-agonist and anticholinergic drug within 1 weeks prior to administration of investigational product
7. Patients who were treated with secretolytics, mucolytics and bronchodilators within 1 day prior to administration of investigational product
8. Patients who are participating in another trial within 30 days prior to screening visit
9. Patients who investigators determines not appropriate to take part in this clinical study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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223 participants in 2 patient groups, including a placebo group

YMC026

Experimental group

Description:

108 subjects will be assigned in this group. They will be administered 20mL of YMC026 three times a day for 6 days.

Treatment:

Drug: YMC026

Placebo

Placebo Comparator group

Description:

108 subjects will be assigned in this group. They will be administered 20mL of placebo three times a day for 6 days.

Treatment:

Drug: Placebo