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

Completed

• Conditions: Rhinitis; Inflammation; Asthma; Hypersensitivity

• Registration Number: NCT02360072
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

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.

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 Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-02-05
• Study First Submitted QC: 2015-02-09
• Study First Posted: 2015-02-10
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-06
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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

Trial Locations

Locations (1)

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