Other Allergic RhinitisNCT02271620
The Prevalence and Clinical Characteristics of Children With Local Allergic Rhinitis
A study testing nasal allergen provocation test in people with Other Allergic Rhinitis, run by Mahidol University at 2 sites in Thailand.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Other Allergic Rhinitis
- What is being tested?
- nasal allergen provocation test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesThailand
- Study dates
- Jan 2014to Apr 2016
- Phase
- Interventional
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Patients with underlying disease:
- chronic rhinosinusitis and nasal polyp
- immunological disease
- chronic renal disease
- hepatobiliary disease
- cardiovascular disease
Show all 9Show fewer
- cancer
- Parental withdraw consent
- Patient with uncontrolled asthma, peak expiratory flow rate (PEFR) < 80% of predicted
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
Division of allergy and immunology, Department of pediatric, Siriraj Hospital
Bangkoknoi, Bangkok, 10700
About this study
- 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)
Read the 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.
- Conditions
- Other Allergic Rhinitis
- Being tested
- nasal allergen provocation test
- Keywords
- 1 prevalence, 2 children, 3 local allergic rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal allergen provocation testProcedure or surgery
nasal allergen provocation test
| Study group | Role | What they receive |
|---|---|---|
| nonallergic rhinitis | Other | nonallergic rhinitis nasal allergen provocation test Receives: Procedure: nasal allergen provocation test |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of local allergic rhinitis (LAR)
positive nasal allergen provocation test with Der p1
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Allergic RhinitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 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, 66815818803
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271620
- Sponsor's protocol ID
- 759/25569(EC3)
- Status last verified
- Mar 2018
- First submitted
- 9 Sep 2014
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence and Clinical Characteristics of Children With Local Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT02271620
- Acronym / sponsor ID
- 759/25569(EC3)
- Conditions
- Other Allergic Rhinitis
- Keywords
- 1 prevalence, 2 children, 3 local allergic rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 22 Oct 2014 (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.
- 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)
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nonallergic rhinitis | Other | Procedure: nasal allergen provocation testnonallergic rhinitis nasal allergen provocation test |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- Patients with underlying disease:
- chronic rhinosinusitis and nasal polyp
- immunological disease
- chronic renal disease
- hepatobiliary disease
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 |
|---|---|---|
| nasal allergen provocation testnasal allergen provocation test | Procedure or surgery | nonallergic rhinitis |
Primary outcome
prevalence of local allergic rhinitis (LAR)
Time frame: 1 year
positive nasal allergen provocation test with Der p1
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 2018.
- 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.
Orathai Piboonpocanun, assoc. prof. principal investigator
66815818803
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasal allergen provocation test in people with Other Allergic Rhinitis, run by Mahidol University at 2 sites 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 7 inclusion and 9 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 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
prevalence of local allergic rhinitis (LAR) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2018.