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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
68
64mcg/1putt, 1 putt/nostril,b.i.d
1 putt/nostril,b.i.d
Guangzhou institute of respiratory disease
Guangzhou, Guangdong, China
Change from baseline fractional exhaled nitric oxide (FeNO) at 3 months
Fractional exhaled nitric oxide (FeNO) measured at 0 w,4 w,8 w and 12 w after treatment
Time frame: 3 months after treatment
Change from baseline eosinophils in sputum at 3 months
Eosinophils in sputum at measured at 0 w,4 w,8 w and 12 w after treatment
Time frame: 3 months after treatment
Changes of lower airway resistance (Z5,R5,X5,R5-20,R20 and Fres) using impulse oscillation
Time frame: 0 w,4 w,8 w and 12 w after treatment
Change of upper airway inflammation biomarker such as eosinophils in nasal lavage
Time frame: 0 w,4 w,8 w and 12 w after treatment
Change of cumulative dosage of methacholine causing a 20% fall in forced expiratory volume in 1 second (PD20FEV1-MCH)
Time frame: 0 w,4 w,8 w and 12 w after treatment
To measure the differences in nasal symptoms score (TSS) about groups after 12 weeks of therapy
The parameters considered in the TSS were: nasal obstruction, sneezing, nasal discharge ,itching. These symptoms were scored: 0 = symptom absent, 1 = mild (symptoms present but not annoying), 2 = moderate (frequent and offensive symptoms but do not interfere with sleep or normal activities) 3 = severe (symptoms that interfere with sleep or normal activities).
Time frame: 0 w,4 w,8 w and 12 w after treatment
The change in visual analogue scale score for symptoms of rhinitis
Time frame: 0 w,4 w,8 w and 12 w after treatment
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Juniper mini RQLQ
Time frame: 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
Time frame: At baseline 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.
Time frame: 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).
Time frame: At the inclusion visit