Status:
COMPLETED
A Clinical Trial to Evaluate the Efficacy and Safety of YMC026 in Respiratory Disease Patients
Lead Sponsor:
Yuhan Corporation
Conditions:
Respiratory Disease
Eligibility:
All Genders
15-74 years
Phase:
PHASE4
Brief 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
Detailed 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 ...
Eligibility Criteria
Inclusion
- Both gender, 15 years ≤ age \< 75 years
- Patients with BSS(Bronchitis Severity Score) ≥ 5point at screening visit and randomization visit
- Written consent voluntarily to participate in this clinical trial
Exclusion
- Patients with severe respiratory disease
- Patients with severe pulmonary disease
- Patients who has history for drug hypersensitivity or allergic reaction in component of investigational product or similar drug
- Patients with pregnant and/or have breast feeding
- Patients who were treated with monoamine oxidase inhibitor, antihistamines, anti-viral drugs and glucocorticoids within 2 weeks prior to administration of investigational product
- Patients who were treated with β2-agonist and anticholinergic drug within 1 weeks prior to administration of investigational product
- Patients who were treated with secretolytics, mucolytics and bronchodilators within 1 day prior to administration of investigational product
- Patients who are participating in another trial within 30 days prior to screening visit
- Patients who investigators determines not appropriate to take part in this clinical study
Key Trial Info
Start Date :
October 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2018
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT03334916
Start Date
October 27 2017
End Date
October 30 2018
Last Update
January 16 2019
Active Locations (1)
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1
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, South Korea