NCT01062139

Cosalin® Monotherapy Versus Cosalin® and Xarlin® Combination Therapy

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: HK inno.N Corporation · Industry
• Sex: All
• Age: 18 Years – 66 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Perennial Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Xarlin (Levocetirizine)	Combination therapy compared to mono therapy
DRUG	Cosalin (Petasites hybridus CO2 extract)	Combination therapy compared to mono therapy

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-04-01
• First posted: 2010-02-04
• Last updated: 2010-02-04