CTRI/2017/06/008889已完成3 期
A Comparative, Two arm, Randomized, Double blind, Parallel group, Non- Crossover, Multicentric Clinical Study to evaluate Efficacy, Safety and Tolerability of Bilastine Tablet 20 mg as compared with Levocetirizine Tablet 5 mg for the Treatment of Allergic Rhinoconjunctivitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 18
- 主要终点
- Mean change in TSS (Total Symptom Score) of Allergic Rhinoconjunctivitis after 28 days treatment with Bilastine Tablets 20 mg Vs. Levocetirizine Tablets 5 mg.
研究概览
简要总结
This study is A Comparative, Two arm, Randomized, Doubleblind, Parallel group, Non- Crossover, Multicentric Clinical Study to evaluateEfficacy, Safety and Tolerability of Bilastine Tablet 20 mg as compared withLevocetirizine Tablet 5 mg for the Treatment of Allergic Rhinoconjunctivitis.
Primary objective of this trial is to study the Mean change in TSS (TotalSymptom Score) of Allergic Rhinoconjunctivitis after 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects of both genders with age ≥ 18 years and ≤ 65 years.
- •2.Subjects with total IgE level ≥75kU/L will be included.
- •3.Subjects with absolute eosinophil count value of 80 cells/ml will be included.
- •4.All patients will additionally require to have a minimum reflective Total nasal symptom (TNSS) score and Total Non-nasal symptoms (Non – TNSS) of ≥ 72 as sum of the six assessments in the last 3 days of the screening period; oTotal Nasal Symptoms (TNSS): obstruction, rhinorrhoea, itching and sneezing oTotal Non-nasal symptoms (Non -TNSS): ocular itching, lacrimation, itching of ears and/or palate and ocular redness Each of these symptoms will be assessed over the preceding 12 hours, twice daily, graded on a pre-determined severity scale of 0-3 to Total nasal symptom (TNSS) score and Total Non-nasal symptoms (Non – TNSS).
- •5.Freshly diagnosed subject will be included in the study.
- •6.Patients with Acute Bronchial Asthma will be included in the study (Diagnosed by Spirometry).
- •7.Female patients of child bearing potential those are non-pregnant and willing to use effective contraceptive method during participation in the study.
- •If the subject is not already consuming Oral Contraceptives, they should opt for IUCD.
- •8.Subject willing to sign informed consent form (ICF) prior to any screening procedure.
排除标准
- •1.Patients with hypersensitivity to H
- •2.Patients with H2 antihistamines within 3 days of randomization.
- •3.Patients with systemic or intranasal corticosteroids within 4 weeks 4.Patients with intranasal and systemic decongestants within 3 days of randomization to treatment will be excluded from the study 5.Patients who had received allergen immunotherapy 6.CNS acting agents (including antidepressants, sedatives, anxiolytics, hypnotics, opioids or neuroleptics) at any time will be also excluded.
- •7.Patients who had undergone nasal surgery in the previous 6 months and patients with nasal polyps, large adenoids, significant deviation of the nasal septum, acute or chronic sinusitis, any injury or tumor in the nose.
- •8.Patients with upper respiratory tract infection.
- •9.Patients with Chronic/ Perennial Asthma 10.Patients who are currently using beta blockers or corticosteroids 11.Patients with parasite infections (such as tapeworms, roundworms, flatworms and ringworms) [Diagnosed by stool test] 12.Any clinically significant condition (cardiovascular, neurological, hepatic, renal or malignant diseases).
- •13.History of alcohol abuse and Current smokers.
- •14.Pregnant or lactating women 15.Patients with Diabetes Mellitus 16.Subjects who have participated in other clinical studies within 3 months 17.Those with any medical condition judged by investigators to possibly jeopardize the evaluation of efficacy and safety of therapy 18.Subject with the following clinically significant laboratory abnormalities: AST, ALT, Serum Bilirubin > 2 x Upper Limit Normal (ULN) Serum Creatinine, BUN > 2 x Upper Limit Normal (ULN).
结局指标
主要结局
Mean change in TSS (Total Symptom Score) of Allergic Rhinoconjunctivitis after 28 days treatment with Bilastine Tablets 20 mg Vs. Levocetirizine Tablets 5 mg.
时间窗: Mean change in TSS (Total Symptom Score) of Allergic Rhinoconjunctivitis after 28 days treatment with Bilastine Tablets 20 mg Vs. Levocetirizine Tablets 5 mg.
次要结局
- 1.QOL (Quality of Life) assessed by the RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire(Day 7, Day 14, Day 21 and Day 28)
研究者
研究点 (18)
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