- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01827176
Clinical Characteristic of Recurrent Acute Rhinosinusitis in Children
March 21, 2017 updated by: JITTIMA VESKITKUL, Mahidol University
The purpose of this study is to determine the clinical characteristic of recurrent acute rhinosinusitis in children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
94
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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Bangkok, Thailand, 10700
- Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
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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
No older than 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The patients from pediatric allergy clinic will be selected.
Description
Inclusion Criteria:
- Children the age less than 15 years with recurrent acute rhinosinusitis who are attending the pediatric allergy clinic during Jan 2010 - Dec 2012.
Exclusion Criteria:
- Children who had lost medical record.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Recurrent Acute Rhinosinusitis
Recurrent Acute Rhinosinusitis is defined as acute rhinosinusitis more than 3 times/6 months or more than 4 times/year
|
Clinical Characteristic of Recurrent Acute Rhinosinusitis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Presenting symptoms of recurrent acute rhinosinusitis
Time Frame: 12 months
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12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Age of onset
Time Frame: 12 months
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12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of sinusitis after received treatment
Time Frame: 12 months
|
12 months
|
|
Immunological profile
Time Frame: 12 months
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immunoglobulin level and immunoglobulin G subclass level
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12 months
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Number of participants with allergic rhinitis
Time Frame: 12 months
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12 months
|
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Number of participants with immunodeficiency
Time Frame: 12 months
|
12 months
|
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Number of participants with adenotonsillar hypertrophy
Time Frame: 12 months
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12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jittima Veskitkul, MD, Mahidol University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
March 1, 2013
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
March 25, 2013
First Submitted That Met QC Criteria
April 4, 2013
First Posted (Estimate)
April 9, 2013
Study Record Updates
Last Update Posted (Actual)
March 22, 2017
Last Update Submitted That Met QC Criteria
March 21, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 094/2556(EC4)
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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