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临床试验/NCT02352168
NCT02352168已完成不适用

To Evaluate Airway Inflammation in Children With Allergic Rhinitis and To Examine the Effects of Nasal Corticosteroids Therapy on Lower Airway Inflammation of Rhinitis.

Guangzhou Institute of Respiratory Disease1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
1
主要终点
Change from baseline eosinophils in sputum at 3 months

研究概览

简要总结

The purpose of this study is to determine whether treating upper airway with intranasal corticosteroids in children with allergic rhinitis and no asthma may bring favors in reducing lower airway inflammation and improving small airway function.

详细描述

Type of study :

This is a prospective randomized,double-blind, placebo-controlled study , to clarity whether treating upper airway with intranasal corticosteroids in children with allergic rhinitis may bring favors in reducing elevated lower airway inflammation,improving airway reactivity and airway resistance.

Methods :

The children with allergic rhinitis accompanied lower airway inflammation such as elevated percentage of eosinophil in induced sputums and/or higher level of fractional exhaled nitric oxide(FeNO) are recruited.By using a random digit table, eligible subjects were randomized into one of two groups,to receive budesonide nasal spray (BUD group) or nasal placebo(placebo group), 1 spray/nostril, 2 times/day, for three consecutive months observation. The following measurements were performed: skin prick test (SPT), peripheral blood cells five-classification test, serum total immunoglobulin E (IgE) and specific IgE of common inhalant allergens testing, nasal lavage and inflammatory cells classification ,pulmonary function test, bronchial provocation test,airway resistance measured by impulse oscillation technique. Meanwhile,history of all subjects were collected, visual analogue scale,rhinitis symptoms scores and rhinoconjunctivitis quality of life questionnaire (RQLQ) scores were evaluated. Symptom scores and laboratory examinations are performed at baseline,4 w,8w and 12 w after treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
6 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • clinical diagnosis of allergic rhinitis without asthma
  • sensitized to more than 1 common aeroaller¬gens
  • FeNO >20ppb and/or induced sputum Eosinophil>2.5%

排除标准

  • Respiratory infection 2 weeks prior to initial visit
  • children with nasal polyposis
  • History of immunotherapy
  • unable to complete the test or had limited understanding
  • Use of systemic corticosteroids 4 weeks prior to initial visit
  • nasal and inhaled corticosteroids 2 weeks prior to initial visit
  • leukotriene receptor antagonists 2 weeks prior to initial visit
  • Use of antihistamines 7 days prior to initial visit

研究组 & 干预措施

Budesonide nasal spray

Active Comparator

Budesonide nasal spray ,64mcg/putt,1 spray/nostril, 2 times/day,for 12 consecutive weeks.

干预措施: Budesonide nasal spray (Drug)

Placebo

Placebo Comparator

Placebo:nasal placebo spray,1spray/nostril, 2 times/day,for 12 consecutive weeks.

干预措施: Placebo (Drug)

结局指标

主要结局

Change from baseline eosinophils in sputum at 3 months

时间窗: 3 months after treatment

Eosinophils in sputum at measured at 0 w,4 w,8 w and 12 w after treatment

Change from baseline fractional exhaled nitric oxide (FeNO) at 3 months

时间窗: 3 months after treatment

Fractional exhaled nitric oxide (FeNO) measured at 0 w,4 w,8 w and 12 w after treatment

次要结局

  • To measure the differences in nasal symptoms score (TSS) about groups after 12 weeks of therapy(0 w,4 w,8 w and 12 w after treatment)
  • Juniper mini RQLQ(0 w,4 w,8 w and 12 w after treatment)
  • Change in levels of eosinophil(ECP),eosinophil peroxidase(EPO), myeloperoxidase (MPO)and eosinophil-derived neurotoxin (EDN) in induced sputum and serum about groups after twelve weeks of therapy(At baseline and 12 w after treatment)
  • Change of cumulative dosage of methacholine causing a 20% fall in forced expiratory volume in 1 second (PD20FEV1-MCH)(0 w,4 w,8 w and 12 w after treatment)
  • Changes of lower airway resistance (Z5,R5,X5,R5-20,R20 and Fres) using impulse oscillation(0 w,4 w,8 w and 12 w after treatment)
  • Change of upper airway inflammation biomarker such as eosinophils in nasal lavage(0 w,4 w,8 w and 12 w after treatment)
  • The change in visual analogue scale score for symptoms of rhinitis(0 w,4 w,8 w and 12 w after treatment)
  • Change in forced vital capacity (FVC) , in forced expiratory volume in 1 second (FEV1),in forced expired flow at 25% of FVC(FEF25) and in forced expired flow at 75% of FVC (FEF75) about groups after twelve weeks of therapy.(0 w,4 w,8 w and 12 w after treatment)
  • Evaluation of the possible association between upper airway inflammation (eosinophil count in nasal lavage) and bronchial (PD20FEV1-MCH,FeNO and eosinophil count in induced sputum).(At the inclusion visit)

研究者

发起方
Guangzhou Institute of Respiratory Disease
申办方类型
Other
责任方
Principal Investigator
主要研究者

LI-HONG SUN

associate professor

Guangzhou Institute of Respiratory Disease

研究点 (1)

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