Guangzhou institute of respiratory disease
Guangzhou, Guangdong, 510120, China
NCT Number: NCT02352168
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.
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Notify Me6 year–14 year
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, 510120, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
64mcg/1putt, 1 putt/nostril,b.i.d
Other names: intanasal corticosteroids
1 putt/nostril,b.i.d
Other names: Placebo nasal spray
Time frame: 3 months after treatment
Fractional exhaled nitric oxide (FeNO) measured at 0 w,4 w,8 w and 12 w after treatment
Time frame: 3 months after treatment
Eosinophils in sputum at measured at 0 w,4 w,8 w and 12 w after treatment
Time frame: 0 w,4 w,8 w and 12 w after treatment
Time frame: 0 w,4 w,8 w and 12 w after treatment
Time frame: 0 w,4 w,8 w and 12 w after treatment
Time frame: 0 w,4 w,8 w and 12 w after treatment
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
Time frame: 0 w,4 w,8 w and 12 w after treatment
Time frame: At baseline and 12 w after treatment
Time frame: 0 w,4 w,8 w and 12 w after treatment
Time frame: At the inclusion visit
Guangzhou Institute of Respiratory Disease
Other
To Evaluate Airway Inflammation in Children With Allergic Rhinitis and To Examine the Effects of Nasal Corticosteroids Therapy on Lower Airway Inflammation of Rhinitis.
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