- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02271620
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
Conditions
Intervention / Treatment
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
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-
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Bangkok, Thailand, 10700
- Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
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Bangkok
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Bangkoknoi, Bangkok, Thailand, 10700
- Division of allergy and immunology, Department of pediatric, Siriraj Hospital
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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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 759/25569(EC3)
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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