Xi Chen1,2, Wei-Jie Guan1, Shi-Xue Sun3, Pei-Yan Zheng1, Li-Hong Sun1, De-Hui Chen1, Dan-Dan Wang3, Chang Chen3, Bao-Qing Sun1, Xiao-Hua Douglas Zhang3. 1. 1 Department of Allergy and Clinical Immunology, Guangzhou Institute of Respiratory Health, State Key Laboratory of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. 2. 2 Department of Clinical Laboratory, Guangzhou Panyu Central Hospital, Guangzhou, China. 3. 3 Faculty of Health Sciences, University of Macau, Taipa, Macau.
Abstract
BACKGROUND:Perennial allergic rhinitis (PAR) often coexists in asthmatic patients. Intranasal cellulose powder (ICP) was reportedly effective in ameliorating PAR. OBJECTIVE: We investigated whether ICP is equally effective compared with intranasal corticosteroids in improving asthma control as well as nasal symptoms among children with PAR and allergic asthma (AA). METHODS: Between July 2015 and September 2016, we did a single-center, randomized, placebo-controlled trial. Asthmatic children aged 6 to 11 years with mild-to-moderate PAR were randomly assigned to formoterol/budesonide inhalation (4·5 µg/80 µg, twice daily) plus intranasal budesonide 64 µg twice daily (group A), ICP 250 µg thrice daily (group B), or intranasal placebo 250 µg thrice daily (group C) for 8 weeks. The primary outcome was change in asthma control test for children (C-ACT) score from baseline to week 8 posttreatment. Changes in spirometry, peak expiratory flow (PEF), fractional exhaled nitric oxide (FeNO), and visual analog scale (VAS) for nasal and ocular symptoms were detected as secondary outcomes. RESULTS: We included 121 patients (38 in group A, 41 in group B, and 42 in group C) in full-analysis set. C-ACT score was markedly higher at week 8 compared with baseline (mean difference: 5.11, 6.05, and 4.85 points in groups A, B, and C, respectively; P < .05). There were interactions between baseline and treatment in C-ACT scores ( P < .05). Group B demonstrated greater improvement in C-ACT score than group C among children with baseline C-ACT score of 6 to 18. 95% confidence intervals of group A at baseline overlapped with those of groups B and C. The treatment achieved reduced VAS symptoms in groups A and B but not in group C. Incidence of adverse events was comparable. No serious adverse event was reported. CONCLUSIONS:ICP could be recommended for children with PAR and AA who have poorer asthma control.
RCT Entities:
BACKGROUND:Perennial allergic rhinitis (PAR) often coexists in asthmatic patients. Intranasal cellulose powder (ICP) was reportedly effective in ameliorating PAR. OBJECTIVE: We investigated whether ICP is equally effective compared with intranasal corticosteroids in improving asthma control as well as nasal symptoms among children with PAR and allergic asthma (AA). METHODS: Between July 2015 and September 2016, we did a single-center, randomized, placebo-controlled trial. Asthmatic children aged 6 to 11 years with mild-to-moderate PAR were randomly assigned to formoterol/budesonide inhalation (4·5 µg/80 µg, twice daily) plus intranasal budesonide 64 µg twice daily (group A), ICP 250 µg thrice daily (group B), or intranasal placebo 250 µg thrice daily (group C) for 8 weeks. The primary outcome was change in asthma control test for children (C-ACT) score from baseline to week 8 posttreatment. Changes in spirometry, peak expiratory flow (PEF), fractional exhaled nitric oxide (FeNO), and visual analog scale (VAS) for nasal and ocular symptoms were detected as secondary outcomes. RESULTS: We included 121 patients (38 in group A, 41 in group B, and 42 in group C) in full-analysis set. C-ACT score was markedly higher at week 8 compared with baseline (mean difference: 5.11, 6.05, and 4.85 points in groups A, B, and C, respectively; P < .05). There were interactions between baseline and treatment in C-ACT scores ( P < .05). Group B demonstrated greater improvement in C-ACT score than group C among children with baseline C-ACT score of 6 to 18. 95% confidence intervals of group A at baseline overlapped with those of groups B and C. The treatment achieved reduced VAS symptoms in groups A and B but not in group C. Incidence of adverse events was comparable. No serious adverse event was reported. CONCLUSIONS: ICP could be recommended for children with PAR and AA who have poorer asthma control.