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The Prevalence and Clinical Characteristics of Children With Local Allergic Rhinitis

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ClinicalTrials.gov Identifier: NCT02271620
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Orathai Piboonpocanun, Mahidol University

Brief Summary:
  • 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)

Condition or disease Intervention/treatment Phase
Other Allergic Rhinitis Procedure: nasal allergen provocation test Not Applicable

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  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Prevalence and Clinical Characteristics of Children With Local Allergic Rhinitis
Actual Study Start Date : January 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
nonallergic rhinitis
nonallergic rhinitis nasal allergen provocation test
Procedure: nasal allergen provocation test
nasal allergen provocation test



Primary Outcome Measures :
  1. prevalence of local allergic rhinitis (LAR) [ Time Frame: 1 year ]
    positive nasal allergen provocation test with Der p1



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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271620


Locations
Thailand
Division of allergy and immunology, Department of pediatric, Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Orathai Piboonpocanun, assoc. prof. 66815818803

Responsible Party: Orathai Piboonpocanun, Division of allergy and immunology, Mahidol University
ClinicalTrials.gov Identifier: NCT02271620     History of Changes
Other Study ID Numbers: 759/25569(EC3)
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Orathai Piboonpocanun, Mahidol University:
1 prevalence
2 children
3 local allergic rhinitis

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases