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Completed

NCT Number: NCT02360072

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To explore if an elevated level of fractional exhaled nitric oxide(FeNO) is a possible predictor of bronchial hyperresponsiveness in AR.

    Time frame: 1 year

Secondary outcomes

  1. To explore if an elevated eosinophils in induced sputum is a possible predictor of bronchial hyperresponsiveness in AR.

    Time frame: 1 year

  2. To explore if an elevated eosinophils in nasal nasal lavage fluid is a possible predictor of bronchial hyperresponsiveness in AR.

    Time frame: 1 year

  3. 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].

    Time frame: 1 year

  4. To compare cumulative dosage of methacholine causing a 20% fall in forced expiratory volume in 1 second (PC20FEV1-MCH) among the groups.

    Time frame: 1 year

  5. 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.

    Time frame: 1 year

  6. 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.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Guangzhou Institute of Respiratory Disease

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 10, 2015
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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