Cosalin® Monotherapy Versus Cosalin® and Xarlin® Combination Therapy

Phase 4

• Conditions: Perennial Allergic Rhinitis
• Interventions: Drug: Xarlin (Levocetirizine); Drug: Cosalin (Petasites hybridus CO2 extract)

• Registration Number: NCT01062139
• Lead Sponsor: HK inno.N Corporation

Brief 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.

Study Timeline

• Study Start: 2009-10
• Status Verified: 2010-02
• Study First Submitted: 2010-02-02
• Study First Submitted QC: 2010-02-03
• Last Update Submitted: 2010-02-03
• Study First Posted: 2010-02-04
• Last Update Posted: 2010-02-04
• Primary Completion: 2010-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Petasites extract, levocetirizine	Xarlin (Levocetirizine)	Cosalin (Petasites hybridus CO2 extract), Xarlin (levocetirizine) combination therapy group
Petasites extract, levocetirizine	Cosalin (Petasites hybridus CO2 extract)	Cosalin (Petasites hybridus CO2 extract), Xarlin (levocetirizine) combination therapy group
Cosalin (Petasites hybridus CO2 extract)	Cosalin (Petasites hybridus CO2 extract)	Cosalin monotherapy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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 evening reflective 4 TSS from baseline to each day by using patient diary.	2 weeks
Compare percent change of instantaneous 5 TSS by using patient diary.	2 weeks
Compare responder rate (> 50% evening reflective 4TSS improvement) by using patient's 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