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
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Petasites extract, levocetirizine
Cosalin (Petasites hybridus CO2 extract), Xarlin (levocetirizine) combination therapy group
干预措施: Xarlin (Levocetirizine) (Drug)
Petasites extract, levocetirizine
Cosalin (Petasites hybridus CO2 extract), Xarlin (levocetirizine) combination therapy group
干预措施: Cosalin (Petasites hybridus CO2 extract) (Drug)
Cosalin (Petasites hybridus CO2 extract)
Cosalin monotherapy
干预措施: Cosalin (Petasites hybridus CO2 extract) (Drug)
结局指标
主要结局
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.
时间窗: 2 weeks
次要结局
- 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 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 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)
- Compare percent change of evening reflective 4 TSS from baseline to each day by using patient diary.(2 weeks)
- Compare percent change of instantaneous 5 TSS by using patient diary.(2 weeks)
- Compare responder rate (> 50% evening reflective 4TSS improvement) by using patient's diary.(2 weeks)
- Compare percent change of instantaneous 4 TSS from baseline to each day by using patient diary.(2 weeks)
- Compare improvement of QoL from baseline to end of treatment, by using RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire).(2 weeks)