NCT02360072

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

February 5, 2015

Last Update Submit

March 6, 2021

Conditions

RhinitisAsthmaInflammationHypersensitivity

Keywords

childallergic rhinitisasthmanitric oxidebronchial hyper-responsiveness

Outcome Measures

Primary Outcomes (1)

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

    1 year

Secondary Outcomes (6)

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

    1 year

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

    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 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

  • +1 more secondary outcomes

Study Arms (4)

AR group

Allergic rhinitis without any typical asthma symptoms

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)

AR+Asthma

Diagnosed allergic rhinitis concomitant asthma symptoms

Control group

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

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • Clinical diagnosis of allergic rhinitis and/or asthma
  • Sensitized to more than 1 common aeroallergens

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou institute of respiratory disease

Guangzhou, Guangdong, 510120, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum ,nasal lavage fluid ,induced sputum

MeSH Terms

Conditions

RhinitisAsthmaInflammationHypersensitivityRhinitis, Allergic

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesBronchial DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nanshan Zhong, master

    Guangzhou Institute of Respiratory Disease

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 5, 2015

First Posted

February 10, 2015

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

March 9, 2021

Record last verified: 2021-03

Locations

CN(1)