The Development of Allergic Rhinitis in Children Previous... | NCT01068808

Studies
The Development of Allergic Rhinitis in Children Previously Diagnosed as Nonallergic Rhinitis

NCT01068808

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Feb 20, 2013Estimated

Enrollment

175Actual

Phase

Not provided

Conditions

Allergic Rhinitis (Disorder)

Interventions

skin prick test

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Jun 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Feb 12, 2010

First Submission Date that Met QC Criteria

Feb 12, 2010

First Posted Date

Feb 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2013

Last Update Posted Date

Feb 20, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Orathai Piboonpocanun, Department of Pediatrics, Faculty of medicine, Siriraj hospital, Mahidol UniversityPrincipal Investigator

Lead Sponsor

Mahidol UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate development of allergic rhinitis in children with nonallergic rhinitis.

Detailed Description

Rhinitis is a common condition associated with significant effects on quality of life. Rhinitis may be divided into two groups, those with concurrent allergy (allergic rhinitis, AR) and those without allergy but who still suffer from nasal symptoms (nonallergic rhinitis, NAR).

Evidence indicated that adult with NAR can have de novo sensitization to aeroallergen (24%), suggesting that patients with NAR might evolve to AR. Thus the purpose of this study is to evaluate development of allergic rhinitis in children with nonallergic rhinitis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

175Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nonallergic rhinitis		Nonallergic rhinitis (negative skin prick test)	Procedure: skin prick test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
skin prick test	Procedure	skin prick test to aeroallergen	Nonallergic rhinitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the development of AR in children who were previously diagnosed with NAR		24 months

Secondary Outcomes

Measure	Description	Time Frame
To determine the persistence and severity of the symptoms, new comorbidities and triggering factors in children with nonallergic rhinitis		24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children between the age of 1 year and 15 years with the diagnosis of nonallergic rhinitis who are attending the pediatric allergy clinic during Jan 2005 - Dec 2007.

Exclusion Criteria:

Patients who have allergic rhinitis and underlying disease eg.chronic renal disease, liver disease, heart disease, cancer.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

15 Years

Standard Ages

Child

Study Population

The patient from pediatric allergy clinic will be selected.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Orathai Piboonpocanun, Assoc.Prof.	Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University		Bangkok	Bangkok	10700	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23406600	Result	Veskitkul J, Vichyanond P, Visitsunthorn N, Jirapongsananuruk O. The development of allergic rhinitis in children previously diagnosed as nonallergic rhinitis. Am J Rhinol Allergy. 2013 Jan;27(1):43-7. doi: 10.2500/ajra.2013.27.3839.

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity

ID	Term
D012882	Skin Tests
D007159	Immunologic Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures