Acute Recurrent SinusitisNCT01827176
Clinical Characteristic of Recurrent Acute Rhinosinusitis in Children
An observational study of Acute Recurrent Sinusitis, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine the clinical characteristic of recurrent acute rhinosinusitis in children. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Acute Recurrent Sinusitis
- What is being tested?
- Recurrent Acute Rhinosinusitis
- How many people
- 94 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2013to Sep 2014
- 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 Up to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: The patients from pediatric allergy clinic will be selected.
Who may be able to join
- Children the age less than 15 years with recurrent acute rhinosinusitis who are attending the pediatric allergy clinic during Jan 2010 - Dec 2012.
Who cannot join
- Children who had lost medical record.
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 determine the clinical characteristic of recurrent acute rhinosinusitis in children.
- Conditions
- Acute Recurrent Sinusitis
- Being tested
- Recurrent Acute Rhinosinusitis
- Keywords
- Characteristic, Recurrent Acute Rhinosinusitis, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recurrent Acute RhinosinusitisOther
Clinical Characteristic of Recurrent Acute Rhinosinusitis
| Study group | Role | What they receive |
|---|---|---|
| Recurrent Acute Rhinosinusitis | Recurrent Acute Rhinosinusitis is defined as acute rhinosinusitis more than 3 times/6 months or more than 4 times/year Receives: Other: Recurrent Acute Rhinosinusitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presenting symptoms of recurrent acute rhinosinusitis
Measured: 12 months
Secondary outcomes (1)
Age of onset
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2014
- Study completionSep 2014
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 Acute Recurrent SinusitisStudies 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
- Retrospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JITTIMA VESKITKUL, Mahidol University
- Investigators
- Jittima Veskitkul, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827176
- Sponsor's protocol ID
- 094/2556(EC4)
- Status last verified
- Mar 2017
- First submitted
- 25 Mar 2013
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Veskitkul J, Vichyanond P, Pacharn P, Visitsunthorn N, Jirapongsananuruk O. Clinical characteristics of recurrent acute rhinosinusitis in children. Asian Pac J Allergy Immunol. 2015 Dec;33(4):276-80. doi: 10.12932/AP0591.33.4.2015.
PubMed 26708390
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristic of Recurrent Acute Rhinosinusitis in Children
- ClinicalTrials.gov ID
- NCT01827176
- Acronym / sponsor ID
- 094/2556(EC4)
- Conditions
- Acute Recurrent Sinusitis
- Keywords
- Characteristic, Recurrent Acute Rhinosinusitis, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 9 Apr 2013 (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 determine the clinical characteristic of recurrent acute rhinosinusitis in children.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recurrent Acute Rhinosinusitis | – | Other: Recurrent Acute RhinosinusitisRecurrent Acute Rhinosinusitis is defined as acute rhinosinusitis more than 3 times/6 months or more than 4 times/year |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The patients from pediatric allergy clinic will be selected.
Key inclusion criteria (1 listed)
- Children the age less than 15 years with recurrent acute rhinosinusitis who are attending the pediatric allergy clinic during Jan 2010 - Dec 2012.
Key exclusion criteria (1 listed)
- Children who had lost medical record.
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 |
|---|---|---|
| Recurrent Acute RhinosinusitisClinical Characteristic of Recurrent Acute Rhinosinusitis | Other | Recurrent Acute Rhinosinusitis |
Primary outcome
Presenting symptoms of recurrent acute rhinosinusitis
Time frame: 12 months
1 secondary outcome
Age of onset
Time frame: 12 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 22 Mar 2017.
- Results publication: PubMed 26708390Veskitkul J, Vichyanond P, Pacharn P, Visitsunthorn N, Jirapongsananuruk O. Clinical characteristics of recurrent acute rhinosinusitis in children. Asian Pac J Allergy Immunol. 2015 Dec;33(4):276-80. doi: 10.12932/AP0591.33.4.2015.
- Individual participant dataSharing planned: No
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.
Jittima Veskitkul, MD principal investigator
Mahidol University
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 Acute Recurrent Sinusitis, 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 22 Mar 2017. 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?
Presenting symptoms of recurrent acute rhinosinusitis (time frame: 12 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 NCT01827176, 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 22 Mar 2017.