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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02360072
Other study ID # GuangzhouIRD-LSUN1
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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