ObjectiveTo assess the clinical effectiveness of fluticasone furoate nasal spray (FFNS) versus placebo on nasal symptoms and safety in children with perennial allergic rhinitis (AR). MethodsA comprehensive review was conducted with data obtained from Medline and Embase databases up to April 2023. The population of interest was patients aged 2-12 years with perennial AR. The selection was limited to randomized controlled trials (RCTs), comparing FFNS with placebo. Outcomes of interest included the reflective total nasal symptoms scores (rTNSS) and safety. To assess the minimal clinically important difference for rTNSS, the Cohen's guideline was used. If the pooled standardized mean difference (SMD) and the lower limit of the 95 percent confidence interval (CI) exceeded the threshold of -0.20, effects were considered clinically significant. ResultsThree RCTs (959 pediatric patients) were selected. One study evaluated the short-term use of FFNS, another evaluated the long-term use of FFNS, and another evaluated both the short-term and long-term use of FFNS. FFNS produced a statistically significant reduction over placebo in rTNSS (SMD -0.18; 95 percent CI -0.35 to -0.01, p = 0.03) in long-term treatment studies, but not in short-term treatment studies. However, since the mean reduction did not reach the minimum clinically important difference (SMD -0.20), these results were considered clinically not relevant. Safety outcomes with FFNS were similar to placebo. ConclusionsThe currently available evidence suggests that FFNS, 110 mu g once daily, compared to placebo, does not produce a meaningful clinical effect on nasal symptom in children with perennial AR.
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Valley Allergy & Asthma Treatment Ctr, Valley Clin Res Ctr, Easton, PA USAValley Allergy & Asthma Treatment Ctr, Valley Clin Res Ctr, Easton, PA USA
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Capital Med Univ, Beijing Childrens Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R ChinaCapital Med Univ, Beijing Childrens Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China
Zhang, Yamei
Wei, Ping
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Chongqing Med Univ, Childrens Hosp, Dept Otolaryngol, Chongqing, Peoples R ChinaCapital Med Univ, Beijing Childrens Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China
Wei, Ping
Chen, Bobei
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Wenzhou Med Univ, Affiliated Hosp 2, Dept Otolaryngol, Wenzhou, Zhejiang, Peoples R ChinaCapital Med Univ, Beijing Childrens Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China
Chen, Bobei
Li, Xiaoyan
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Shanghai Jiao Tong Univ, Childrens Hosp, Dept Otolaryngol Head & Neck Surg, Shanghai, Peoples R ChinaCapital Med Univ, Beijing Childrens Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China
Li, Xiaoyan
Luo, Xianyang
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Xiamen Univ, Med Coll, Affiliated Hosp 1, Dept Otolaryngol Head & Neck Surg, Xiamen, Fujian, Peoples R ChinaCapital Med Univ, Beijing Childrens Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China
Luo, Xianyang
Chen, Xianming
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Fuzhou Gen Hosp, Dept Otorhinolaryngol, Fuzhou, Fujian, Peoples R ChinaCapital Med Univ, Beijing Childrens Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China
Chen, Xianming
Xiang, Mingliang
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Shanghai Jiao Tong Univ, Sch Med, Ruijin Hosp, Dept Otolaryngol Head & Neck Surg, Shanghai, Peoples R ChinaCapital Med Univ, Beijing Childrens Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China
Xiang, Mingliang
Li, Lan
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Shenzhen Childrens Hosp, Dept Otolaryngol, Shenzhen, Guangdong, Peoples R ChinaCapital Med Univ, Beijing Childrens Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China
Li, Lan
Zhao, Sijun
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Hunan Childrens Hosp, Dept Otolaryngol & Head & Neck Surg, Changsha, Hunan, Peoples R ChinaCapital Med Univ, Beijing Childrens Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China
Zhao, Sijun
Xiao, Xuping
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Hunan Normal Univ, Affiliated Hosp 1, Hunan Prov Peoples Hosp, Dept Otolaryngol Head & Neck Surg, Changsha, Hunan, Peoples R ChinaCapital Med Univ, Beijing Childrens Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China
Xiao, Xuping
Yang, Xinmin
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Cent South Univ, Xiangya Hosp 2, Dept Otolaryngol Head & Neck Surg, Changsha, Hunan, Peoples R ChinaCapital Med Univ, Beijing Childrens Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China
Yang, Xinmin
Chen, Jie
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Shanghai Jiao Tong Univ, Sch Med, Shanghai Childrens Med Ctr, Dept Otorhinolaryngol Head & Neck Surg, Shanghai, Peoples R ChinaCapital Med Univ, Beijing Childrens Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China
Chen, Jie
Fu, Yong
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Zhejiang Univ, Sch Med, Childrens Hosp, Dept Otolaryngol Head & Neck Surg, Hangzhou, Zhejiang, Peoples R ChinaCapital Med Univ, Beijing Childrens Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China
Fu, Yong
Xiao, Shuifang
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Peking Univ First Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R ChinaCapital Med Univ, Beijing Childrens Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China
Xiao, Shuifang
Liu, Haixia
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Shanxi Childrens Hosp, Taiyuan, Shanxi, Peoples R ChinaCapital Med Univ, Beijing Childrens Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China
Liu, Haixia
Cheng, Lei
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Nanjing Med Univ, Affiliated Hosp 1, Dept Otorhinolaryngol, Nanjing, Jiangsu, Peoples R China
Nanjing Med Univ, Affiliated Hosp 1, Clin Allergy Ctr, Nanjing, Jiangsu, Peoples R China
Nanjing Med Univ, Int Ctr Allergy Res, Nanjing, Jiangsu, Peoples R ChinaCapital Med Univ, Beijing Childrens Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China
Cheng, Lei
Yao, Hongbing
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Chongqing Med Univ, Childrens Hosp, Dept Otolaryngol, Chongqing, Peoples R ChinaCapital Med Univ, Beijing Childrens Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China