“A Phase III, Prospective, Randomized, Double Blind, Active-Controlled, Comparative, Parallel Group and Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Bilastine 10 mg plus Montelukast 4 mg Oral Suspension Versus FDC of Levocetirizine 2.5 mg plus Montelukast 4 mg Oral Suspension in patients with allergic rhinitis.â€
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 11
- 主要终点
- The change in Total Symptom Score [(TSS is the sum Total nasal symptom score (TNSS) and Total Non-Nasal symptom score (TNNSS)] at the end of study as compared to baseline.
研究概览
简要总结
Thistrial is a phase III, prospective, randomized,double blind, active-controlled, comparative, parallel group and multicentricclinical study to evaluate the efficacy, safety and tolerability of FDC ofBilastine 10 mg + Montelukast 4 mg Oral Suspension versus FDC of Levocetirizine2.5 mg + Montelukast 4 mg Oral Suspension in patients with allergic rhinitis.
Patientswho are willing and able to participate in the study will sign and date theInformed Assent Form or Oral assent in the presence of his/her parent or LAR onthe day of screening / baseline visit (Visit 1). During this screening period, patientswho are willing to give informed assent or oral assent will be evaluated forall the eligibility criteria. Eligible patients aged between 6 to 11 years(both inclusive) with a history of allergic rhinitis, a positive skin pricktest to at least one relevant allergen and active symptoms of allergic rhinitisat study entry, elevated serum IgE levels (>100 IU/mL) and Total Nasal SymptomScore (TNSS) at baseline ≥ 4 will be considered for the study.
After confirming the inclusion/exclusion criteria thesubject will be randomized and provided with study medication at randomizationvisit. Subjects will be provided with patient diary at randomization visit,which need to be brought along with in each subsequent visit till the lastvisit. Follow up visits will be done on week 1/day 7(±2) and week 2/day 14(±2) (FinalVisit) of treatment to assess efficacy and safety.
Patientswill be assigned to either of the two arms i.e. Arm A or Arm B consisting of FDCof Bilastine 10 mg + Montelukast 4 mg Oral Suspension or FDC of Levocetirizine 2.5mg + Montelukast 4 mg Oral Suspension. Patients will be advised to take 5 mL oforal suspension once a day orally one hour before or two hours after mealsaround same time every day for 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 11.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients aged between 6 and 11 years (both inclusive).
- •Patients with a history of allergic rhinitis, a positive skin prick test to at least one relevant allergen and active symptoms of allergic rhinitis at study entry.
- •Patients with elevated serum IgE levels (>100 IU/mL) at screening or baseline visit.
- •Patients with Total Nasal Symptom Score (TNSS) at screening or baseline ≥
- •Written informed assent or oral consent from the patient, legally acceptable representative or parent and able to follow study procedures.
排除标准
- •Patients with hypersensitivity to either of the study medications or any of the ingredients of the formulation.
- •Patients with Electrocardiographic abnormalities including conduction delay and an abnormal QTc interval.
- •Patients with upper respiratory tract infections including cold and systemic infections within 3 weeks of baseline/screening visit.
- •Patients with history of renal, hepatic, gastrointestinal tract, cardiovascular, respiratory, haematological, endocrine or neurological diseases.
- •Patients with clinically significant impaired hepatic function [SGOT & SGPT more than 2.5X the UNL].
- •Patients who had initiation of allergen immunotherapy within previous 6 months.
- •Patients with history of Rhinitis medicamentosa, non-allergic rhinitis or substantial structural nasal obstruction.
- •Patients with history of nasal polyps or any clinically important nasal anomaly.
- •Patients with history of acute and/or chronic sinusitis within 30 days of baseline/screening visit.
- •Patients with history of eye surgery or intranasal surgery within 3 months of baseline/screening visit.
- •Patient with severe asthma requiring emergency room treatment within 1 month or hospitalization within 3 month before the trial.
- •Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to screening visit.
- •Currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
- •Suspected inability or unwillingness to comply with the study procedures.
结局指标
主要结局
The change in Total Symptom Score [(TSS is the sum Total nasal symptom score (TNSS) and Total Non-Nasal symptom score (TNNSS)] at the end of study as compared to baseline.
时间窗: At Day 1, Day 7 and Day 14.
次要结局
- The change in Total nasal symptom score (TNSS) at the end of study as compared to baseline.(At Day 1, Day 7 and Day 14.)
- The assessment of safety of patients [comparison of incidence of treatment emergent adverse event (TEAE)].(Throughout the study.)
- The change in Total non-nasal symptom score (TNNSS) at the end of study as compared to baseline.(At Day 1, Day 7 and Day 14.)
- The assessment of tolerability of investigational product will be based on incidence of AEs and SAEs and changes in laboratory values.(AE & SAE - Throughout the study.)