Efficacy and safety of olopatadine-mometasone combination nasal spray for the treatment of seasonal allergic rhinitis
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Background Patients with moderate-to-severe allergic rhinitis (AR) often experience a heavy clinical burden and require more medications to alleviate nasal symptoms. The aim of this study was to evaluate the efficacy and safety of GSP301, a fixed-dose combination nasal spray containing olopatadine hydrochloride and mometasone furoate, in patients with seasonal AR (SAR). Methods In this multicenter, randomized, double-blind, parallel-group study, moderate-to-severe SAR patients were assigned at a 1:1:1 ratio to receive intranasal GSP301, olopatadine hydrochloride (OLO), or mometasone furoate (MF) for 14 days. The primary endpoint was the change from baseline in the average A.M. and P.M. 12-hour reflective total nasal symptom score (rTNSS). Secondary endpoints included changes in the instantaneous TNSS (iTNSS), individual nasal symptoms, reflective total ocular symptom score (rTOSS), instantaneous total ocular symptom score (iTOSS), individual ocular symptoms, and rhinoconjunctivitis quality-of-life questionnaire (RQLQ). Exploratory endpoints and adverse events were also analyzed. Results Among the 534 subjects, the GSP301 group demonstrated statistically significant improvements in the average rTNSS compared with the OLO group [posterior least square mean difference (LSMD) = −0.56; P < 0.0001] and the MF group (posterior LSMD=−0.43; P < 0.0001). Consistent benefits were observed across secondary endpoints, including iTNSS, rTOSS, RQLQ, and individual nasal and ocular symptoms (all P < 0.05). Additionally, GSP301 reduced the levels of interleukin (IL)-5 and eosinophilic cationic protein (ECP) in nasal secretions. Treatment-emergent adverse events (TEAEs) occurred in 11.2%, 13.5%, and 11.3% of patients in the GSP301, OLO, and MF groups, respectively. Conclusion Compared with OLO and MF, GSP301 demonstrated superior efficacy, safety, and potential advantages in alleviating local inflammation in patients with moderate-to-severe SAR.
Authors: Yutong Sima, Xueyan Wang, Xueyan Wang, Tao Zhang, Zhiwei Cao, Wei Chen, Fang Quan, Xiaoyong Ren, Yi Yang, Shiping Bao, Lifeng Xie, Changqing Zhao, Qinna Zhang, Zhimin Xing, Huifang Zhou, Jianjun Chen, Qingquan Hua, Ling Zhou, Xiaobing Zhang, Xiong Chen, Chao Li, Ruixia Ma, Hua Zhang, Zhendong Xu, Mei Han, Xiangdong Wang, Xiangdong Wang, Luo Zhang
Institutions: Beijing Tongren Hospital, Capital Medical University, Beijing Municipal Education Commission, Beijing Shijitan Hospital, Nankai University, Sheng Jing Hospital, China Medical University, Central Hospital of Wuhan, Huazhong University of Science and Technology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an Jiaotong University, Second Affiliated Hospital of Xi'an Jiaotong University, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Hospital, Beijing YouAn Hospital, Peking University Third Hospital, Shanxi Medical University, Second Hospital of Shanxi Medical University, First Hospital of Shanxi Medical University, Peking University People's Hospital, Tianjin Medical University General Hospital, Tianjin Medical University, Wuhan Union Hospital, Renmin Hospital of Wuhan University, First Affiliated Hospital of Heilongjiang University of Chinese Medicine, First Hospital of Lanzhou University, Zhongnan Hospital of Wuhan University, Second Hospital of Tianjin Medical University, Yinchuan First People's Hospital, Xinjiang Medical University, First Affiliated Hospital of Xinjiang Medical University, Baotou Central Hospital, Changchun University of Chinese Medicine, The Affiliated Hospital to Changchun University of Chinese Medicine
Language: English
Subfield: Immunology and Allergy
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,508
Funder: Glenmark Pharmaceuticals
OpenAlex ID: W7128821980