Cosalin® Monotherapy Versus Cosalin® and Xarlin® Combination Therapy

NCT01062139 | Unknown Phase 4

• 1 other identifier: CJ_COS_M01
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Perennial Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

Study Arms (2)

Petasites extract, levocetirizine

EXPERIMENTAL

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

Drug: Xarlin (Levocetirizine); Drug: Cosalin (Petasites hybridus CO2 extract)

Cosalin (Petasites hybridus CO2 extract)

ACTIVE COMPARATOR

Cosalin monotherapy

Drug: Cosalin (Petasites hybridus CO2 extract)

Interventions

Xarlin (Levocetirizine) DRUG

Combination therapy compared to mono therapy

Also known as: Cosalin (Petasites hybridus CO2 extract), Xyarin (levocetirizine)

Petasites extract, levocetirizine

Cosalin (Petasites hybridus CO2 extract) DRUG

Combination therapy compared to mono therapy

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

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• HK inno.N Corporation: lead

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

levocetirizine

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 4, 2010
• Study Start: October 1, 2009
• Primary Completion: April 1, 2010
• Last Updated: February 4, 2010

Record last verified: 2010-02