Efficacy and safety of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride in Perennial Allergic Rhinitis (PAR) patients: A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial

Hanmi Pharm0 个研究点目标入组 280 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

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•Patients with at least 2 years history of PAR prior to the study
•- Positive results of skin prick test
•- Patients who provided a signed written informed consent form
•- Patients who are able and willing to complete subject diaries
•- Patients who agree to maintain consistency in their surroundings throughout the study period

•- Patients also with non-allergic rhinitis with different causes.
•- Patients with severe asthma
•- Presence of nasal polyps or any clinically important nasal anomaly.
•- History of acute ? chronic sinusitis within 30 days of Visit 1
•- History of intranasal / eye surgeries within 3 months of Visit 1
•- Initiation of immunotherapy or dose modification within 1 month prior to Visit 1
•- Upper respiratory infections including cold and systemic infections within 3 weeks of Visit 1.
•- Chronic use of tricyclic antidepressants, beta agonists, bronchodilators, etc. that may affect the efficacy of study drug
•- At Visit 2, patients who recorded Daytime Nasal Symptom Scores for fewer than 4 days in the subject diary during the last one week of baseline period

发起方

Hanmi Pharm