Perennial Allergic RhinitisPhase 4NCT01062139
Cosalin® Monotherapy Versus Cosalin® and Xarlin® Combination Therapy
A Phase 4 study testing Xarlin (Levocetirizine) and Cosalin (Petasites hybridus CO2 extract) in people with Perennial Allergic Rhinitis, run by HK inno.N Corporation.
Trial 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 … Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- Xarlin (Levocetirizine) and Cosalin (Petasites hybridus CO2 extract)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Apr 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 13Show fewer
- 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
About this study
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
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.
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- Xarlin (Levocetirizine), Cosalin (Petasites hybridus CO2 extract)
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xarlin (Levocetirizine)Drug
Also called Cosalin (Petasites hybridus CO2 extract), Xyarin (levocetirizine)
Combination therapy compared to mono therapy
Cosalin (Petasites hybridus CO2 extract)Drug
Combination therapy compared to mono therapy
| Study group | Role | What they receive |
|---|---|---|
| Petasites extract, levocetirizine | Experimental | Cosalin (Petasites hybridus CO2 extract), Xarlin (levocetirizine) combination therapy group Receives: Drug: Xarlin (Levocetirizine); Drug: Cosalin (Petasites hybridus CO2 extract) |
| Cosalin (Petasites hybridus CO2 extract) | Active comparator | Cosalin monotherapy Receives: Drug: Cosalin (Petasites hybridus CO2 extract) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (10)
Compare percent change of evening reflective 4 TSS from baseline to end of treatment by using patient diary.
Measured: 2 weeks
Compare percent change of instantaneous 4 TSS from baseline to end of treatment by using patient diary.
Measured: 2 weeks
Compare percent change of evening reflective nasal congestion score from baseline to end of treatment by using patient diary.
Measured: 2 weeks
Compare percent change of instantaneous nasal congestion score from baseline to end of treatment by using patient diary.
Measured: 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.
Measured: 2 weeks
Compare percent change of instantaneous 5 TSS by using patient diary.
Measured: 2 weeks
Compare percent change of evening reflective 4 TSS from baseline to each day by using patient diary.
Measured: 2 weeks
Compare percent change of instantaneous 4 TSS from baseline to each day by using patient diary.
Measured: 2 weeks
Compare improvement of QoL from baseline to end of treatment, by using RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire).
Measured: 2 weeks
Compare responder rate (> 50% evening reflective 4TSS improvement) by using patient's diary.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startOct 2009
- Primary completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perennial Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062139
- Sponsor's protocol ID
- CJ_COS_M01
- Status last verified
- Feb 2010
- First submitted
- 2 Feb 2010
- Last updated
- 4 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01062139
- Acronym / sponsor ID
- CJ_COS_M01
- Conditions
- Perennial Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Apr 2010 (estimated)
- First posted
- 4 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Petasites extract, levocetirizine | Experimental | Drug: Xarlin (Levocetirizine), Drug: Cosalin (Petasites hybridus CO2 extract)Cosalin (Petasites hybridus CO2 extract), Xarlin (levocetirizine) combination therapy group |
| Cosalin (Petasites hybridus CO2 extract) | Active comparator | Drug: Cosalin (Petasites hybridus CO2 extract)Cosalin monotherapy |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xarlin (Levocetirizine)Also: Cosalin (Petasites hybridus CO2 extract), Xyarin (levocetirizine)Combination therapy compared to mono therapy | Drug | Petasites extract, levocetirizine |
| Cosalin (Petasites hybridus CO2 extract)Combination therapy compared to mono therapy | Drug | Cosalin (Petasites hybridus CO2 extract), Petasites extract, levocetirizine |
Primary outcome
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
10 secondary outcomes
Compare percent change of evening reflective 4 TSS from baseline to end of treatment by using patient diary.
Time frame: 2 weeks
Compare percent change of instantaneous 4 TSS from baseline to end of treatment by using patient diary.
Time frame: 2 weeks
Compare percent change of evening reflective nasal congestion score from baseline to end of treatment by using patient diary.
Time frame: 2 weeks
Compare percent change of instantaneous nasal congestion score from baseline to end of treatment by using patient diary.
Time frame: 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.
Time frame: 2 weeks
Compare percent change of instantaneous 5 TSS by using patient diary.
Time frame: 2 weeks
Compare percent change of evening reflective 4 TSS from baseline to each day by using patient diary.
Time frame: 2 weeks
Compare percent change of instantaneous 4 TSS from baseline to each day by using patient diary.
Time frame: 2 weeks
Compare improvement of QoL from baseline to end of treatment, by using RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire).
Time frame: 2 weeks
Compare responder rate (> 50% evening reflective 4TSS improvement) by using patient's diary.
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xarlin (Levocetirizine) and Cosalin (Petasites hybridus CO2 extract) in people with Perennial Allergic Rhinitis, run by HK inno.N Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2010.