Airway Inflammation in Children With Allergic Rhinitis and Intervention
NCT ID: NCT02352168
Last Updated: 2021-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
68 participants
INTERVENTIONAL
2014-09-30
2015-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Budesonide nasal spray
Budesonide nasal spray ,64mcg/putt,1 spray/nostril, 2 times/day,for 12 consecutive weeks.
Budesonide nasal spray
64mcg/1putt, 1 putt/nostril,b.i.d
Placebo
Placebo:nasal placebo spray,1spray/nostril, 2 times/day,for 12 consecutive weeks.
Placebo
1 putt/nostril,b.i.d
Interventions
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Budesonide nasal spray
64mcg/1putt, 1 putt/nostril,b.i.d
Placebo
1 putt/nostril,b.i.d
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* sensitized to more than 1 common aeroaller¬gens
* FeNO \>20ppb and/or induced sputum Eosinophil\>2.5%
Exclusion Criteria
* 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
6 Years
14 Years
ALL
Yes
Sponsors
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Guangzhou Institute of Respiratory Disease
OTHER
Responsible Party
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LI-HONG SUN
associate professor
Principal Investigators
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Nanshanzhong Zhong, master
Role: PRINCIPAL_INVESTIGATOR
Guangzhou Institute of Respiratory Disease
Locations
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Guangzhou institute of respiratory disease
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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GuangzhouIRD-LSUN
Identifier Type: -
Identifier Source: org_study_id
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