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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02360072
• Other study ID #: GuangzhouIRD-LSUN1
• Status: Completed
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: March 2021
• Source: Guangzhou Institute of Respiratory Disease
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Bronchial Hyperreactivity
• Hypersensitivity
• Inflammation
• Rhinitis

Locations

Country	Name	City	State
China	Guangzhou institute of respiratory disease	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To explore if an elevated level of fractional exhaled nitric oxide(FeNO) is a possible predictor of bronchial hyperresponsiveness in AR.		1 year
Secondary	To explore if an elevated eosinophils in induced sputum is a possible predictor of bronchial hyperresponsiveness in AR.		1 year
Secondary	To explore if an elevated eosinophils in nasal nasal lavage fluid is a possible predictor of bronchial hyperresponsiveness in AR.		1 year
Secondary	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
Secondary	To compare cumulative dosage of methacholine causing a 20% fall in forced expiratory volume in 1 second (PC20FEV1-MCH) among the groups.		1 year
Secondary	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
Secondary	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