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Cosalin® Monotherapy Versus Cosalin® and Xarlin® Combination Therapy

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
CJ Cheiljedang Corporation
ClinicalTrials.gov Identifier:
NCT01062139
First received: February 2, 2010
Last updated: February 3, 2010
Last verified: February 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Perennial Allergic Rhinitis
 Drug: Xarlin (Levocetirizine)
Drug: Cosalin (Petasites hybridus CO2 extract)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CJ Cheiljedang Corporation:

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. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare percent change of evening reflective 4 TSS from baseline to end of treatment by using patient diary. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Compare percent change of instantaneous 4 TSS from baseline to end of treatment by using patient diary. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Compare percent change of evening reflective nasal congestion score from baseline to end of treatment by using patient diary. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Compare percent change of instantaneous nasal congestion score from baseline to end of treatment by using patient diary. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Compare percent change of instantaneous 5 TSS by using patient diary. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Compare percent change of evening reflective 4 TSS from baseline to each day by using patient diary. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Compare percent change of instantaneous 4 TSS from baseline to each day by using patient diary. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Compare improvement of QoL from baseline to end of treatment, by using RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire). [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Compare responder rate (> 50% evening reflective 4TSS improvement) by using patient's diary. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: October 2009
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 66 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Hyo Hyoung, Lee / CRA, CJ Cheiljedang Corporation
ClinicalTrials.gov Identifier: NCT01062139     History of Changes
Other Study ID Numbers: CJ_COS_M01
Study First Received: February 2, 2010
Last Updated: February 3, 2010
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Levocetirizine
 Cetirizine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013