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

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Hypersensitivity; Asthma; Rhinitis

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 Type: Observational
• Enrollment (Actual): 280

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Guangzhou Institute of Respiratory Disease

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children 6-15 years old with allergic rhinitis and/or asthma diagnosed by specialist physician were enrolled in the department of paediatrics,respiratory and otorhinolaryngology in Guangzhou Institue of Respiratory Diseas .In addition, healthy students in a school were enrolled as normal control group.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Guangzhou Institute of Respiratory Disease
• Investigators: Study Director: Nanshan Zhong, master, Guangzhou Institute of Respiratory Disease

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: February 5, 2015
• First Submitted That Met QC Criteria: February 9, 2015
• First Posted (Estimate): February 10, 2015

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 6, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: asthma; child; allergic rhinitis; nitric oxide; bronchial hyper-responsiveness
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Otorhinolaryngologic Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Nose Diseases; Hypersensitivity; Inflammation; Asthma; Rhinitis; Bronchial Hyperreactivity
• Other Study ID Numbers: GuangzhouIRD-LSUN1