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
- 214
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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 â?? 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 â?? 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 H1.
- •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)
研究者
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