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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02360072
Enrollment
280
Registered
2015-02-10
Start date
2014-09-30
Completion date
2015-09-30
Last updated
2021-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Hypersensitivity, Inflammation, Rhinitis

Keywords

child, allergic rhinitis, asthma, nitric oxide, bronchial hyper-responsiveness

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.

Interventions

None listed

Sponsors

Guangzhou Institute of Respiratory Disease
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
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
To explore if an elevated eosinophils in induced sputum is a possible predictor of bronchial hyperresponsiveness in AR.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 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 explore if an elevated eosinophils in nasal nasal lavage fluid is a possible predictor of bronchial hyperresponsiveness in AR.1 year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026