Intranasal budesonide for rhinitis during a high airborne pollution period: a randomized controlled trial

Yuan Zhang; Chunguang Shan; Weiwei Liu; Yaozhong Han; Guanggang Shi; Yongjian Ma; Kerstin Wagner; Xiaoyan Tian; Lili Zhang; Allan Joseph Larona; Steven Sacavage; Kathleen Franklin; Chengshuo Wang; Luo Zhang

doi:10.1186/s13223-022-00686-y

Intranasal budesonide for rhinitis during a high airborne pollution period: a randomized controlled trial

Allergy Asthma Clin Immunol. 2022 Jun 20;18(1):56. doi: 10.1186/s13223-022-00686-y.

Authors

Yuan Zhang^{1

2

3}, Chunguang Shan⁴, Weiwei Liu⁵, Yaozhong Han⁶, Guanggang Shi⁷, Yongjian Ma⁸, Kerstin Wagner⁹, Xiaoyan Tian¹⁰, Lili Zhang¹⁰, Allan Joseph Larona¹¹, Steven Sacavage⁹, Kathleen Franklin⁹, Chengshuo Wang^{12

13

14}, Luo Zhang^{15

16

17}

Affiliations

¹ Department of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, China.
² Beijing Laboratory of Allergic Diseases and Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otolaryngology, Beijing, People's Republic of China.
³ Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China.
⁴ Department of Otolaryngology Head and Neck Surgery, The Second Hospital to Hebei Medical University, Shijiazhuang, Hebei, China.
⁵ Department of Otolaryngology Head and Neck Surgery, Cangzhou Center Hospital, Cangzhou, Hebei, China.
⁶ Department of Otolaryngology Head and Neck Surgery, The No.2 Hospital of Baoding, Baoding, Hebei, China.
⁷ Department of Otolaryngology Head and Neck Surgery, Shandong Provincial Hospital, Jinan, Shandong, China.
⁸ Department of Otolaryngology Head and Neck Surgery, The No.2 People's Hospital of Weifang, Weifang, Shandong, China.
⁹ Johnson & Johnson Consumer Inc, Fort Washington, PA, USA.
¹⁰ Johnson & Johnson Consumer China Ltd, Shanghai, China.
¹¹ Johnson & Johnson Consumer Regional Office Asia Pacific, Singapore, Singapore.
¹² Department of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, China. wangcs830@126.com.
¹³ Beijing Laboratory of Allergic Diseases and Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otolaryngology, Beijing, People's Republic of China. wangcs830@126.com.
¹⁴ Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China. wangcs830@126.com.
¹⁵ Department of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, China. dr.luozhang@139.com.
¹⁶ Beijing Laboratory of Allergic Diseases and Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otolaryngology, Beijing, People's Republic of China. dr.luozhang@139.com.
¹⁷ Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China. dr.luozhang@139.com.

Abstract

Background: Air pollution may induce or reinforce nasal inflammation regardless of allergy status. There is limited direct clinical evidence informing the treatment of airborne pollution-related rhinitis.

Objective: To assess the effectiveness of intranasal budesonide in adults with self-reported rhinitis symptoms triggered/worsened by airborne pollution.

Methods: Adults in northern China with self-reported rhinitis symptoms triggered or worsened by airborne pollution were randomized to budesonide 256 µg/day or placebo for 10 days in pollution season (October 2019 to February 2020). The primary endpoint was the mean change from baseline in 24-h reflective total nasal symptom score (rTNSS) averaged over 10 days. The secondary endpoints were subject-assessed Global Impression of Change (SGIC), mean change from baseline in individual nasal symptom severity, and mean change from baseline in individual non-nasal symptoms of cough and postnasal drip severity. One-sided P < 0.0125 was considered statistically significant.

Results: After an interruption by COVID-19, an interim analysis showed that the study could be ended for efficacy with n = 206 participants (103/group) since the primary efficacy endpoint demonstrated significant results. The final efficacy results showed that the 10-day-averaged rTNSS change in the budesonide group was greater than with placebo (- 2.20 vs - 1.72, P = 0.0107). Budesonide also significantly improved 10-day-averaged itching/sneezing change (- 0.75 vs - 0.51, P = 0.0009). Results for SGIC and all other individual symptoms did not show significant differences between the two groups.

Conclusions: Intranasal budesonide 256 µg once daily improved the total nasal symptoms and itching/sneezing over 10 days in adults with rhinitis triggered/worsened by airborne pollution.

Keywords: Air quality index; Airborne pollution; Budesonide; Intranasal corticosteroid; Intranasal spray; Non-allergic rhinitis; Perennial allergic rhinitis; Pollution; Rhinitis; Seasonal allergic rhinitis.