The Prevalence and Clinical Characteristics of Children With Local Allergic Rhinitis

March 21, 2018 updated by: Orathai Piboonpocanun, Mahidol University
  • To determine prevalence of local allergic rhinitis (LAR)
  • To evaluate clinical characteristic and severity of local allergic rhinitis
  • To measure changing of tryptase and Specific IgE for Dermatophagoides pteronyssinus (Dp) after nasal allergen provocation test (NAPT)

Study Overview

Status

Completed

Detailed Description

Children 8-18 years with NAR were recruited. A NAPT with Der p 1 solutions (NAPT-DP) at 200 AU/mL, 600 AU/mL and 2000 AU/mL at 15-minute interval was performed, respectively. The immediate responses to NAPT-DP were assessed using symptoms score, peak nasal inspiratory flow (PNIF) and acoustic rhinometry (ARM). The nasal tryptase and sIgE-DP were measured at baseline, 15 min and 1 h after positive NAPT-DP. Allergic rhinitis (AR) patients were used as positive control.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bangkok, Thailand, 10700
        • Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Division of allergy and immunology, Department of pediatric, Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children 8-15 years who were diagnosed with nonallergic rhinitis (NAR) at least 1 year
  • No respiratory infections in the previous 4 weeks
  • No following treatment of
  • systemic corticosteroid 4 weeks
  • intranasal corticosteroid 2 weeks
  • oral antihistamine 1 week
  • leukotriene antagonist 1 week

Exclusion Criteria:

  • Patients with underlying disease:
  • chronic rhinosinusitis and nasal polyp
  • immunological disease
  • chronic renal disease
  • hepatobiliary disease
  • cardiovascular disease
  • cancer
  • Parental withdraw consent
  • Patient with uncontrolled asthma, peak expiratory flow rate (PEFR) < 80% of predicted

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: nonallergic rhinitis
nonallergic rhinitis nasal allergen provocation test
nasal allergen provocation test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of local allergic rhinitis (LAR)
Time Frame: 1 year
positive nasal allergen provocation test with Der p1
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Orathai Piboonpocanun, assoc. prof., 66815818803

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

September 9, 2014

First Submitted That Met QC Criteria

October 19, 2014

First Posted (Estimate)

October 22, 2014

Study Record Updates

Last Update Posted (Actual)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 21, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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