Airway Inflammation in Children With Allergic Rhinitis and Intervention

Not Applicable

Completed

• Conditions: Allergic Rhinitis; Inflammation; Respiratory Tract Diseases; Hypersensitivity
• Interventions: Drug: Placebo; Drug: Budesonide nasal spray

• Registration Number: NCT02352168
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-01-21
• Study First Submitted QC: 2015-01-30
• Study First Posted: 2015-02-02
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-06
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo:nasal placebo spray,1spray/nostril, 2 times/day,for 12 consecutive weeks.
Budesonide nasal spray	Budesonide nasal spray	Budesonide nasal spray ,64mcg/putt,1 spray/nostril, 2 times/day,for 12 consecutive weeks.

Primary Outcome Measures

Name	Time	Method
Change from baseline eosinophils in sputum at 3 months	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	3 months after treatment	Fractional exhaled nitric oxide (FeNO) measured at 0 w,4 w,8 w and 12 w after treatment

Secondary Outcome Measures

Name	Time	Method
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	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).
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
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
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
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

Trial Locations

Locations (1)

Guangzhou institute of respiratory disease; 🇨🇳 Guangzhou, Guangdong, China