Clinical trial NCT02360072: Airway Inflammation and Bronchial Hyperresponsiveness in Rhinitic Children With or Without Asthma
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis
Asthma
Inflammation
Hypersensitivity
Keywords: child
allergic rhinitis
asthma
nitric oxide
bronchial hyper-responsiveness
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2015-02-10
Enrollment: 280
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To explore if an elevated level of fractional exhaled nitric oxide(FeNO) is a possible predictor of bronchial hyperresponsiveness in AR.
timeFrame: 1 year
Secondary outcomes:
measure: To explore if an elevated eosinophils in induced sputum is a possible predictor of bronchial hyperresponsiveness in AR.
timeFrame: 1 year
measure: To explore if an elevated eosinophils in nasal nasal lavage fluid is a possible predictor of bronchial hyperresponsiveness in AR.
timeFrame: 1 year
measure: 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].
timeFrame: 1 year
measure: To compare cumulative dosage of methacholine causing a 20% fall in forced expiratory volume in 1 second (PC20FEV1-MCH) among the groups.
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou institute of respiratory disease
state: Guangdong
Study officials:
affiliation: Guangzhou Institute of Respiratory Disease
name: Nanshan Zhong, master
role: STUDY_DIRECTOR
References: