Airway Inflammation and Bronchial Hyperresponsiveness in Rhinitic Children With or Without Asthma

Sponsor

Guangzhou Institute of Respiratory Disease (Other)

Overall Status

Completed

CT.gov ID

NCT02360072

Collaborator

(none)

280

Enrollment

Location

Duration (Months)

23.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective observational study , to clarity the characteristics of airway inflammation, airway reactivity and airway resistance in rhinitic children with or without asthma and to explore the possible predictors in the progression of allergic rhinitis to asthma.

Condition or Disease	Intervention/Treatment	Phase
Rhinitis Asthma Inflammation Hypersensitivity

Detailed Description

Children 6-15 years old with allergic rhinitis and/or asthma diagnosed by specialist physician are enrolled in the department of respiratory and otorhinolaryngology and pediatrics in Guangzhou Institute of Respiratory Disease. According to presence of typical symptoms and signs, patients are divided into allergic rhinitis without asthma (AR group) , allergic rhinitis concomitant asthma (AS+AR group), asthma without rhinitis (AS group). In addition, healthy students in a school are enrolled as normal control group. History of all subjects are collected, the following measurements are 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 induced sputum cells classification ，pulmonary function test, bronchial provocation test using methacholine，airway resistance measured by impulse oscillation technique, the levels of eosinophil（ECP），eosinophil peroxidase（EPO）.Meanwhile myeloperoxidase （MPO）and eosinophil-derived neurotoxin (EDN) are measured in induced sputum ,in nasal lavage and in serum.

Study Design

Study Type:

Observational

Actual Enrollment :

280 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

To Delineate the Characteristics of Airway Inflammation and Bronchial Hyperresponsiveness in Rhinitic Children With or Without Asthma and Sought to Explore a Possible Predictor in the Progression of Allergic Rhinitis to Asthma

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
AR group Allergic rhinitis without any typical asthma symptoms
Asthma Accompanied by typical asthma symptoms and Δ FEV1≥12% in response to a short-acting bronchodilator or bronchial hyperreactivity(BHR) in the methacholine provocation test (PC20≤2.504mg)
AR+Asthma Diagnosed allergic rhinitis concomitant asthma symptoms
Control group non-atopic subjects with neither a history of rhinitis nor asthma

Outcome Measures

Primary Outcome Measures

To explore if an elevated level of fractional exhaled nitric oxide(FeNO) is a possible predictor of bronchial hyperresponsiveness in AR. [1 year]

Secondary Outcome Measures

To explore if an elevated eosinophils in induced sputum is a possible predictor of bronchial hyperresponsiveness in AR. [1 year]
To explore if an elevated eosinophils in nasal nasal lavage fluid is a possible predictor of bronchial hyperresponsiveness in AR. [1 year]
To compare lower airway resistance (Z5,R5,X5,R5-20,R20 and Fres) using impulse oscillation among the groups [Allergic rhinitis(AR) group, Asthma group, AR+Asthma and control group]. [1 year]
To compare cumulative dosage of methacholine causing a 20% fall in forced expiratory volume in 1 second (PC20FEV1-MCH) among the groups. [1 year]
To compare forced vital capacity (FVC) , forced expiratory volume in 1 second (FEV1)， forced expired flow at 25% of FVC(FEF25) and forced expired flow at 75% of FVC (FEF75) among groups. [1 year]
To compare levels of eosinophil（ECP），eosinophil peroxidase（EPO）, myeloperoxidase （MPO）and eosinophil-derived neurotoxin (EDN) in induced sputum and nasal lavage fluid among the groups. [1 year]