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Status unknownNCT01062139Updated Feb 4, 2010

Cosalin® Monotherapy Versus Cosalin® and Xarlin® Combination Therapy

A Phase 4 interventional study of Xarlin (Levocetirizine) and Cosalin (Petasites hybridus CO2 extract) in Perennial Allergic Rhinitis, sponsored by HK inno.N Corporation. Status unknown. Open to participants aged 18 Years to 66 Years. Per ClinicalTrials.gov, last updated 2010-02-04.

Sponsored by HK inno.N Corporation · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2010), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 66 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Perennial Allergic Rhinitis
03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 100 is above the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

HK inno.N Corporation is the lead sponsor of 99 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 66 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Petasites extract, levocetirizine

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

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

  • Active comparator
    Cosalin (Petasites hybridus CO2 extract)

    Cosalin monotherapy

    Drug: Cosalin (Petasites hybridus CO2 extract)

Interventions

  • DrugXarlin (Levocetirizine)

    Combination therapy compared to mono therapy

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

  • DrugCosalin (Petasites hybridus CO2 extract)

    Combination therapy compared to mono therapy

06

What researchers measure

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.

    Time frame: 2 weeks

Secondary outcomes

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

    Time frame: 2 weeks

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

    Time frame: 2 weeks

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

    Time frame: 2 weeks

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

    Time frame: 2 weeks

  5. 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

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

    Time frame: 2 weeks

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

    Time frame: 2 weeks

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

    Time frame: 2 weeks

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

    Time frame: 2 weeks

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

    Time frame: 2 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01062139
Lead sponsor
HK inno.N Corporation
First posted
Feb 4, 2010
Start date
Oct 2009
Primary completion
Apr 2010 (estimated)
Last update
Feb 4, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

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