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Cosalin® Monotherapy Versus Cosalin® and Xarlin® Combination Therapy

Primary Purpose

Perennial Allergic Rhinitis

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Xarlin (Levocetirizine)

Cosalin (Petasites hybridus CO2 extract)

About this trial

This is an interventional treatment trial for Perennial Allergic Rhinitis

Eligibility Criteria

18 Years - 66 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female volunteer more than 18 years old and less than 66 years old.
A volunteer who is informed about this study and sign the informed consent.
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.
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:

A volunteer who has hypersensitivity to Levocetirizine or Hydroxyzine
A volunteer who has hypersensitivity to Petasites hybridus leaves.
A volunteer who has anaphylaxis or hypersensitivity to allergy skin test.
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).
A volunteer who need to use steroids cause of asthma.
A volunteer who is using steroids, decongestants, antihistamine.
A volunteer who has rhinitis medicamentosa.
A volunteer who has seasonal allergic rhinitis.
A volunteer who has Galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption genetic disorder .
A volunteer who is an alcoholic or a drug addict.
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.
A volunteer who has experience to take test products in 1 month.
A volunteer who is concluded poor compliance or fail to follow medical instruction

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Petasites extract, levocetirizine

Cosalin (Petasites hybridus CO2 extract)

Arm Description

Cosalin (Petasites hybridus CO2 extract), Xarlin (levocetirizine) combination therapy group

Cosalin monotherapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Compare percent change of evening reflective 4 TSS from baseline to end of treatment by using patient diary.

Compare percent change of instantaneous 4 TSS from baseline to end of treatment by using patient diary.

Compare percent change of evening reflective nasal congestion score from baseline to end of treatment by using patient diary.

Compare percent change of instantaneous nasal congestion score from baseline to end of treatment by using patient diary.

Compare percent change of evening reflective 5 TSS (5 TSS - runny nose, itchy nose, sneezing, ocular symptom, nasal congestion)by using patient diary.

Compare percent change of instantaneous 5 TSS by using patient diary.

Compare percent change of evening reflective 4 TSS from baseline to each day by using patient diary.

Compare percent change of instantaneous 4 TSS from baseline to each day by using patient diary.

Compare improvement of QoL from baseline to end of treatment, by using RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire).

Compare responder rate (> 50% evening reflective 4TSS improvement) by using patient's diary.

Full Information

NCT ID

NCT01062139

First Posted

February 2, 2010

Last Updated

February 3, 2010

Sponsor

HK inno.N Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01062139

Brief Title

Cosalin® Monotherapy Versus Cosalin® and Xarlin® Combination Therapy

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Unknown status

Study Start Date

October 2009 (undefined)

Primary Completion Date

April 2010 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

HK inno.N Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Perennial Allergic Rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Petasites extract, levocetirizine

Arm Type

Experimental

Arm Description

Cosalin (Petasites hybridus CO2 extract), Xarlin (levocetirizine) combination therapy group

Arm Title

Cosalin (Petasites hybridus CO2 extract)

Arm Type

Active Comparator

Arm Description

Cosalin monotherapy

Intervention Type

Drug

Intervention Name(s)

Xarlin (Levocetirizine)

Other Intervention Name(s)

Cosalin (Petasites hybridus CO2 extract), Xyarin (levocetirizine)

Intervention Description

Combination therapy compared to mono therapy

Intervention Type

Drug

Intervention Name(s)

Cosalin (Petasites hybridus CO2 extract)

Intervention Description

Combination therapy compared to mono therapy

Primary Outcome Measure Information:

Title

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.

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Compare percent change of evening reflective 4 TSS from baseline to end of treatment by using patient diary.

Time Frame

2 weeks

Title

Compare percent change of instantaneous 4 TSS from baseline to end of treatment by using patient diary.

Time Frame

2 weeks

Title

Compare percent change of evening reflective nasal congestion score from baseline to end of treatment by using patient diary.

Time Frame

2 weeks

Title

Compare percent change of instantaneous nasal congestion score from baseline to end of treatment by using patient diary.

Time Frame

2 weeks

Title

Compare percent change of evening reflective 5 TSS (5 TSS - runny nose, itchy nose, sneezing, ocular symptom, nasal congestion)by using patient diary.

Time Frame

2 weeks

Title

Compare percent change of instantaneous 5 TSS by using patient diary.

Time Frame

2 weeks

Title

Compare percent change of evening reflective 4 TSS from baseline to each day by using patient diary.

Time Frame

2 weeks

Title

Compare percent change of instantaneous 4 TSS from baseline to each day by using patient diary.

Time Frame

2 weeks

Title

Compare improvement of QoL from baseline to end of treatment, by using RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire).

Time Frame

2 weeks

Title

Compare responder rate (> 50% evening reflective 4TSS improvement) by using patient's diary.

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

66 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female volunteer more than 18 years old and less than 66 years old. A volunteer who is informed about this study and sign the informed consent. 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. 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: A volunteer who has hypersensitivity to Levocetirizine or Hydroxyzine A volunteer who has hypersensitivity to Petasites hybridus leaves. A volunteer who has anaphylaxis or hypersensitivity to allergy skin test. 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). A volunteer who need to use steroids cause of asthma. A volunteer who is using steroids, decongestants, antihistamine. A volunteer who has rhinitis medicamentosa. A volunteer who has seasonal allergic rhinitis. A volunteer who has Galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption genetic disorder . A volunteer who is an alcoholic or a drug addict. 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. A volunteer who has experience to take test products in 1 month. A volunteer who is concluded poor compliance or fail to follow medical instruction

12. IPD Sharing Statement

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Cosalin® Monotherapy Versus Cosalin® and Xarlin® Combination Therapy

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