A Prospective, Multi-Centric, Double Blind, Parallel Group, Active Controlled Randomized Study to Evaluate the Efficacy and Safety of Bilastine and Montelukast Fixed Dose Combination tablets in Adult Patients with Allergic Rhinitis

Hetero Labs Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年12月19日

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•1. Adult male or female patients with age of 18 to 65 years and willing to give written, signed, and dated informed consent to participate in the study
•2. Patients with documented and/or clinical history of Allergic Rhinitis (AR), for at least 1 year prior to the study inclusion
•3. Patients with moderate to severe baseline 12-hour nasal symptom score
•4. Females of childbearing potential who are sexually active must agree to use adequate contraception
•5. Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range

•1. Patients who have non-allergic rhinitis (vasomotor, infectious, drug-induced)
•2. Patients who had undergone nasal surgery within the previous 6 months.
•3. Patients with nasal polyps, significant deviation of the nasal septum or significant nasal tract structural malformation
•4. Patients with a history of acute or chronic sinusitis, asthma or any other condition that can interfere with the aim of the study.
•5. Patients with Upper respiratory tract infections within 3 weeks prior to the study
•6. Patients planning to travel outside of the study area during the course of the study
•7. Patients who will be operating heavy machinery or need to drive motor vehicles as an essential part of their profession
•8. Patients with HIV infection, chronic hepatitis B, or hepatitis C Infection
•9. Currently participating in another investigational study or has participated in an investigational study within 30 days prior to Screening.

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