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

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.

Study Overview

• Status: Unknown
• Conditions: Perennial Allergic Rhinitis
• Intervention / Treatment: Drug: Xarlin (Levocetirizine); Drug: Cosalin (Petasites hybridus CO2 extract)

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male and female volunteer more than 18 years old and less than 66 years old.
2. A volunteer who is informed about this study and sign the informed consent.
3. A volunteer who is diagnosed perennial allergic rhinitis greater than grade3 at visit 1(screening visit) by allergy skin test or serum IgE antibody assay in 24 months.
4. A volunteer who has score 8 and more than 8 point 4 Total Symptom Score (4TSS - runny nose, nasal congestion, itchy nose, sneezing).

Exclusion Criteria:

1. A volunteer who has hypersensitivity to Levocetirizine or Hydroxyzine
2. A volunteer who has hypersensitivity to Petasites hybridus leaves.
3. A volunteer who has anaphylaxis or hypersensitivity to allergy skin test.
4. A volunteer who has serious renal failure or liver failure. Ingestion of antibiotics during previous two weeks from Visit 1, cause of upper respiratory infection(include paranasal sinus).
5. A volunteer who need to use steroids cause of asthma.
6. A volunteer who is using steroids, decongestants, antihistamine.
7. A volunteer who has rhinitis medicamentosa.
8. A volunteer who has seasonal allergic rhinitis.
9. A volunteer who has Galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption genetic disorder .
10. A volunteer who is an alcoholic or a drug addict.
11. Women who are pregnant, breast-feeding, women who plan to get pregnant during the trial period, or do not use authorized contraceptive methods (e.g: sterilization, intrauterine device, combined use of oral contraceptives and barrier contraceptive, combined use of other hormone delivery systems and barrier contraceptive and combined use of contraceptive cream, jelly or foam and diaphragm or condom) in spite of possibility of pregnancy.
12. A volunteer who has experience to take test products in 1 month.
13. A volunteer who is concluded poor compliance or fail to follow medical instruction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Petasites extract, levocetirizine; Cosalin (Petasites hybridus CO2 extract), Xarlin (levocetirizine) combination therapy group	Drug: Xarlin (Levocetirizine); Combination therapy compared to mono therapy; Other Names: Cosalin (Petasites hybridus CO2 extract); Xyarin (levocetirizine); Drug: Cosalin (Petasites hybridus CO2 extract); Combination therapy compared to mono therapy
Active Comparator: Cosalin (Petasites hybridus CO2 extract); Cosalin monotherapy	Drug: Cosalin (Petasites hybridus CO2 extract); Combination therapy compared to mono therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Compare efficacy improvement of combination therapy group and mono therapy group by percent change of 4 TSS from baseline to end of treatment by investigator.	2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Compare percent change of evening reflective 4 TSS from baseline to end of treatment by using patient diary.	2 weeks
Compare percent change of instantaneous 4 TSS from baseline to end of treatment by using patient diary.	2 weeks
Compare percent change of evening reflective nasal congestion score from baseline to end of treatment by using patient diary.	2 weeks
Compare percent change of instantaneous nasal congestion score from baseline to end of treatment by using patient diary.	2 weeks
Compare percent change of evening reflective 5 TSS (5 TSS - runny nose, itchy nose, sneezing, ocular symptom, nasal congestion)by using patient diary.	2 weeks
Compare percent change of instantaneous 5 TSS by using patient diary.	2 weeks
Compare percent change of evening reflective 4 TSS from baseline to each day by using patient diary.	2 weeks
Compare percent change of instantaneous 4 TSS from baseline to each day by using patient diary.	2 weeks
Compare improvement of QoL from baseline to end of treatment, by using RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire).	2 weeks
Compare responder rate (> 50% evening reflective 4TSS improvement) by using patient's diary.	2 weeks

Collaborators and Investigators

• Sponsor: HK inno.N Corporation

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Anticipated): April 1, 2010
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: February 2, 2010
• First Submitted That Met QC Criteria: February 3, 2010
• First Posted (Estimate): February 4, 2010

Study Record Updates

• Last Update Posted (Estimate): February 4, 2010
• Last Update Submitted That Met QC Criteria: February 3, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Cetirizine; Levocetirizine
• Other Study ID Numbers: CJ_COS_M01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No