Allergic Rhinitis (Disorder)NCT01068808
The Development of Allergic Rhinitis in Children Previously Diagnosed as Nonallergic Rhinitis
An observational study of Allergic Rhinitis (Disorder), run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to evaluate development of allergic rhinitis in children with nonallergic rhinitis. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Allergic Rhinitis (Disorder)
- What is being tested?
- skin prick test
- Type of treatment
- Surgery or procedure
- How many people
- 175 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2010to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: The patient from pediatric allergy clinic will be selected.
Who may be able to join
- 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.
Who cannot join
- Patients who have allergic rhinitis and underlying disease eg.chronic renal disease, liver disease, heart disease, cancer.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700
About this study
The purpose of this study is to evaluate development of allergic rhinitis in children with nonallergic rhinitis.
Read the 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.
- Conditions
- Allergic Rhinitis (Disorder)
- Being tested
- skin prick test
- Keywords
- Nonallergic rhinitis, Allergic rhinitis, Development
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin prick testProcedure or surgery
Also called SPT
skin prick test to aeroallergen
| Study group | Role | What they receive |
|---|---|---|
| Nonallergic rhinitis | Nonallergic rhinitis (negative skin prick test) Receives: Procedure: skin prick test |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the development of AR in children who were previously diagnosed with NAR
Measured: 24 months
Secondary outcomes (1)
To determine the persistence and severity of the symptoms, new comorbidities and triggering factors in children with nonallergic rhinitis
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic Rhinitis (Disorder)Studies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orathai Piboonpocanun, Mahidol University
- Investigators
- Orathai Piboonpocanun, Assoc.Prof., Principal investigator, Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068808
- Sponsor's protocol ID
- 640/2552(EC4)
- Status last verified
- Feb 2013
- First submitted
- 12 Feb 2010
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23406600
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Allergic Rhinitis in Children Previously Diagnosed as Nonallergic Rhinitis
- ClinicalTrials.gov ID
- NCT01068808
- Acronym / sponsor ID
- 640/2552(EC4)
- Conditions
- Allergic Rhinitis (Disorder)
- Keywords
- Nonallergic rhinitis, Allergic rhinitis, Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 15 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nonallergic rhinitis | – | Procedure: skin prick testNonallergic rhinitis (negative skin prick test) |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The patient from pediatric allergy clinic will be selected.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who have allergic rhinitis and underlying disease eg.chronic renal disease, liver disease, heart disease, cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin prick testAlso: SPTskin prick test to aeroallergen | Procedure or surgery | Nonallergic rhinitis |
Primary outcome
To evaluate the development of AR in children who were previously diagnosed with NAR
Time frame: 24 months
1 secondary outcome
To determine the persistence and severity of the symptoms, new comorbidities and triggering factors in children with nonallergic rhinitis
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
- Results publication: PubMed 23406600Veskitkul 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orathai Piboonpocanun, Assoc.Prof. principal investigator
Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis (Disorder), run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the development of AR in children who were previously diagnosed with NAR (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01068808, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2013.