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

• Status: Completed
• Trial end date: 2018-10-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhan Corporation

Criteria

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