孟鲁卡斯特
医学
左西替利嗪
非索非那定
哮喘
随机对照试验
临床终点
内科学
麻醉
鼻塞
不利影响
过敏
胃肠病学
药理学
外科
鼻子
免疫学
作者
Shubhadeep Sinha,Sridevi Perapogu,Sreenivasa Chary Sriramadasu,Sunidhi Ramesh,Jaimanti Bakshi,Ajit Singh,Abdul Khabeer Ahmed,B. Mohan Reddy,Muralidhar Panapakam,Leela Talluri,Ramya Vattipalli
标识
DOI:10.1080/02770903.2023.2209175
摘要
AbstractBackground Histamine and cysteinyl leukotrienes (CysLTs) are potent inflammatory mediators in allergic rhinitis (AR). Studies involving other combinations of antihistaminics (Levocetirizine) and highly selective leukotriene receptor antagonist (LTA) (Montelukast) combination have shown additive benefits and are widely prescribed for AR.Objective Evaluate the efficacy and safety of Bilastine 20 mg and Montelukast 10 mg fixed-dose combination (FDC) therapy in patients with AR.Methods A randomized, double-blind, comparative, parallel, phase III study was conducted to evaluate efficacy and safety of Bilastine 20 mg and Montelukast 10 mg FDC at 16 tertiary care otolaryngology centres in India. Adult patients with AR for one year with IgE antibody positive and 12-h NSS score >36 in 3 days were randomized to receive either Bilastine 20 mg and Montelukast 10 mg or Montelukast 10 mg & Levocetirizine 5 mg tablets for 4 weeks. The change in total symptom score (nasal symptom scores (NSS) & non-nasal symptom scores (NNSS)) from baseline to week 4 was assessed as primary endpoint. Secondary endpoints included changes in TSS, NSS, NNSS, individual symptom scores (ISS), Rhinoconjunctivitis Quality of Life (RQLQ), discomfort due to rhinitis (VAS), and clinical global impression (CGI) scores.Results The change in mean TSS from baseline to week 4 in Test group (16.6 units) was comparable to reference group (17 units) (p= 0.8876). The difference in change in mean NSS, NNSS and ISS from baseline to day 7, 14, 28 were comparable. RQLQ improved from baseline to Day 28. Significant improvements were observed in discomfort due to AR measured by VAS and CGI scores from baseline to day 14 and 28. The safety and tolerability of patients were comparable between the groups. All adverse events (AEs) were mild to moderate in severity. No patient discontinued due to AEs.Conclusions The FDC of Bilastine 20 mg and Montelukast 10 mg was efficacious and well tolerated in Indian patients with AR.Keywords: Second-generation antihistamineleukotriene receptor antagonistsafetyclinical trialtotal symptom scoreallergic rhinitisfixed-dose combination Disclosure statementNone declared.Additional informationFundingThis study was sponsored by Hetero Labs Limited.
科研通智能强力驱动
Strongly Powered by AbleSci AI