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

NCT ID: NCT02360072

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 280 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-09-30

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.

Conditions

Rhinitis; Asthma; Inflammation; Hypersensitivity

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

AR group

Allergic rhinitis without any typical asthma symptoms

No interventions assigned to this group

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)

No interventions assigned to this group

AR+Asthma

Diagnosed allergic rhinitis concomitant asthma symptoms

No interventions assigned to this group

Control group

non-atopic subjects with neither a history of rhinitis nor asthma

No interventions assigned to this group

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role: lead

Responsible Party

LI-HONG SUN

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nanshan Zhong, master

Role: STUDY_DIRECTOR

Guangzhou Institute of Respiratory Disease

Locations

Guangzhou institute of respiratory disease

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

GuangzhouIRD-LSUN1

Identifier Type: -

Identifier Source: org_study_id