Clinical trial NCT02352168: Airway Inflammation in Children With Allergic Rhinitis and Intervention
Official title: To Evaluate Airway Inflammation in Children With Allergic Rhinitis and To Examine the Effects of Nasal Corticosteroids Therapy on Lower Airway Inflammation of Rhinitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinitis
Inflammation
Respiratory Tract Diseases
Hypersensitivity
Keywords: allergic rhinitis；airway inflammation；hyperreactivity
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2015-02-02
Enrollment: 68
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline fractional exhaled nitric oxide (FeNO) at 3 months
timeFrame: 3 months after treatment
measure: Change from baseline eosinophils in sputum at 3 months
timeFrame: 3 months after treatment
Secondary outcomes:
measure: Changes of lower airway resistance (Z5,R5,X5,R5-20,R20 and Fres) using impulse oscillation
timeFrame: 0 w,4 w,8 w and 12 w after treatment
measure: Change of upper airway inflammation biomarker such as eosinophils in nasal lavage
timeFrame: 0 w,4 w,8 w and 12 w after treatment
measure: Change of cumulative dosage of methacholine causing a 20% fall in forced expiratory volume in 1 second (PD20FEV1-MCH)
timeFrame: 0 w,4 w,8 w and 12 w after treatment
measure: To measure the differences in nasal symptoms score (TSS) about groups after 12 weeks of therapy
timeFrame: 0 w,4 w,8 w and 12 w after treatment
measure: The change in visual analogue scale score for symptoms of rhinitis
timeFrame: 0 w,4 w,8 w and 12 w after treatment
measure: Juniper mini RQLQ
timeFrame: 0 w,4 w,8 w and 12 w after treatment
measure: 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
timeFrame: At baseline and 12 w after treatment
measure: 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.
timeFrame: 0 w,4 w,8 w and 12 w after treatment
measure: 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).
timeFrame: At the inclusion visit
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou institute of respiratory disease
state: Guangdong
Study officials:
affiliation: Guangzhou Institute of Respiratory Disease
name: Nanshanzhong Zhong, master
role: PRINCIPAL_INVESTIGATOR
References: