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Cosalin® Monotherapy Versus Cosalin® and Xarlin® Combination Therapy | Clinical Trials | Clareo Health

UNKNOWNPHASE4

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

NCT01062139•HK inno.N Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 66 years

Sex

ALL

Healthy Volunteers

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.
+3 more criteria

Key Dates

Start Date

October 1, 2009

Primary Completion Date

April 1, 2010

Last Updated

February 4, 2010

Enrollment

100

ACTUAL participants

Conditions

Perennial Allergic Rhinitis

Interventions

Xarlin (Levocetirizine)

DRUG

Cosalin (Petasites hybridus CO2 extract)

DRUG

A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis

NCT01425632

Perennial Allergic Rhinitis

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TERMINATEDPHASE3

Efficacy and Safety Evaluation for the Treatment of Asthma and Allergic Rhinitis/Rhinoconjunctivitis

NCT04874714

Allergic RhinoconjunctivitisPerennial Allergic Rhinitis+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Cosalin® Monotherapy Versus Cosalin® and Xarlin® Combination Therapy

Inclusion Criteria

Exclusion Criteria

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