Efficacy and Safety of Modified Yupingfeng Nasal Spray in Controlling the Recurrence of Persistent and Moderate-Severe Allergic Rhinitis: Study Protocol for a Multicenter, Open-Label, Randomized, and Parallel-Arm Trial

Abstract

Background. Recurrent episode of allergic rhinitis (AR) is one of the leading illnesses that affects patients. However, there is little research evidence to support pharmacotherapy for AR recurrence. Therefore, this study was designed to explore the efficacy of pharmacotherapy in the control of the recurrence of AR. Methods. In this study, a multicenter, open-label, randomized, and parallel-arm trial will be conducted at three study centers. A total of 190 subjects aged 18–65 with persistent and moderate-severe AR (Qi deficiency and blood stasis syndrome) will be randomly assigned to receive the modified Yupingfeng nasal spray or mometasone furoate aqueous nasal spray. When subjects’ rhinitis control assessment test (RCAT) score is >21 for two weeks, they will stop taking the medication and enter the follow-up. Once a relapse occurs, the time point will be recorded, and the follow-up stops. The primary outcome is the six-month recurrence rate of AR after intervention withdrawal. The secondary outcomes are the one-month recurrence rate of AR, the RCAT score, the duration of follow-up, the duration of medication, the nasal endoscopic results, and questionnaires to evaluate symptoms, signs, and quality of life. The mechanism outcomes include some indicators that may be associated with AR recurrence. In addition, electrocardiograms and other safety indicators will be applied to evaluate the drug’s safety. Discussion. This is the first study to explore the efficacy of traditional Chinese medicine nasal spray on AR from the perspective of controlling recurrence. The results of this trial may provide valuable clinical evidence for controlling the recurrence of this disease by pharmacotherapy. Trial Registration. This study was registered with registration number ChiCTR2100047053 (Chinese Clinical Trial Registry, https://www.chictr.org.cn/showproj.aspx?proj=127432 on June 7, 2021).