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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Rhinitis, Asthma, Inflammation, Hypersensitivity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of allergic rhinitis and/or asthma Sensitized to more than 1 common aeroallergens 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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AR group<br>Allergic rhinitis without any typical asthma symptoms | |
| Asthma<br>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<br>Diagnosed allergic rhinitis concomitant asthma symptoms | |
| Control group<br>non-atopic subjects with neither a history of rhinitis nor asthma | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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child, allergic rhinitis, asthma, nitric oxide, bronchial hyper-responsiveness