Perennial Allergic Rhinitis Clinical Trial
Official title:
A Randomized, Parallel, Double-blind, Multi-center, Comparative Study to Exploratively Evaluate the Efficacy and Safety of Cosalin® Monotherapy vs. Cosalin® and Xarlin® Combination Therapy in Patients With Allergic Rhinitis
Title of Study:
A randomized, parallel, double-blind, multi-center, comparative study to evaluate the
efficacy and safety of Cosalin monotherapy versus Cosalin and Xarlin combination therapy in
patients with allergic rhinitis
Objective of study:
To exploratively evaluate superiority of combination therapy - twice-daily Cosalin Tab
(Petasites hybridus CO2 extract) with once-daily Xarlin Tab (Levocetirizine HCl) - compared
to monotherapy of Cosalin with allergic rhinitis subjects.
Number of Subjects:
Total 100 subjects / Each group 50 subjects (combination therapy group, monotherapy group /
include 20% of subjects drop out rate)
Test Products:
Cosarlin (Petasites hybridus CO2 extract) 30 mg tablet Xarlin (Levocetirizine HCl) 5 mg
tablet
Study Design:
Development Phase: Phase IV Randomized, double blind, active-controlled, multi-center study
The subject, who is to satisfy inclusion criteria and not to satisfy any of exclusion
criteria will be allocated 1:1 to combination therapy group or mono therapy group,
randomized.
Written informed consent will be obtained from the subjects prior to study entry.
Dose, Mode of administration:
Monotherapy group - Cosalin 30mg tablet two times daily. Combination therapy group - Cosalin
30mg tablet two times daily and Xarlin 5mg tablet once daily.
Duration of Tx:
2 Weeks
Safety Endpoint:
Physical Exam, Adverse Events, Vital Signs at Visit 2 and 3.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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