Back to resultsThe Prevalence and Clinical Characteristics of Children With Local Allergic Rhinitis
Primary Purpose
Other Allergic Rhinitis
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
nasal allergen provocation test
Sponsored by
About this trial
This is an interventional diagnostic trial for Other Allergic Rhinitis focused on measuring 1 prevalence, 2 children, 3 local allergic rhinitis
Eligibility 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
Sites / Locations
- Division of allergy and immunology, Department of pediatric, Siriraj Hospital
- Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
nonallergic rhinitis
Arm Description
nonallergic rhinitis nasal allergen provocation test
Outcomes
Primary Outcome Measures
prevalence of local allergic rhinitis (LAR)
positive nasal allergen provocation test with Der p1
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02271620
Brief Title
The Prevalence and Clinical Characteristics of Children With Local Allergic Rhinitis
Official Title
The Prevalence and Clinical Characteristics of Children With Local Allergic Rhinitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Allergic Rhinitis
Keywords
1 prevalence, 2 children, 3 local allergic rhinitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nonallergic rhinitis
Arm Type
Other
Arm Description
nonallergic rhinitis nasal allergen provocation test
Intervention Type
Procedure
Intervention Name(s)
nasal allergen provocation test
Intervention Description
nasal allergen provocation test
Primary Outcome Measure Information:
Title
prevalence of local allergic rhinitis (LAR)
Description
positive nasal allergen provocation test with Der p1
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orathai Piboonpocanun, assoc. prof.
Organizational Affiliation
66815818803
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of allergy and immunology, Department of pediatric, Siriraj Hospital
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Prevalence and Clinical Characteristics of Children With Local Allergic Rhinitis
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