Allergic Rhinitis Due to Animal Hair and DanderNCT03645161
Comparison Between Local and Imported Skin Prick Testing Result of Rat and Mouse Allergen Extracts
A study testing rat and mouse skin test in people with Allergic Rhinitis Due to Animal Hair and Dander, run by Mahidol University at 1 site in Thailand.
Trial summary
In respiratory allergy patients, skin prick test results of local rat and mouse allergen extracts are not significant different from imported ones Read more about this study
- Who is it for?
- Ages 3 to 60 years
- Conditions the study is for
- Allergic Rhinitis Due to Animal Hair and Dander
- What is being tested?
- rat and mouse skin test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteThailand
- Study dates
- 30 May 2018to 30 Jul 2019
- 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 3 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients age 3 to 60 years old who diagnosed with asthma or allergic rhinitis
- Patient must not take these following medication at least 7 days before doing the skin prick test: antihistamine, oral corticosteroid (more than 20 mg/day of prednisolone), topical steroid that was apply on skin test area.
Who cannot join
- Pateints who have other chronic underlying disease e.g. obesity, heart disease and liver disease
- Patient with allergic asthma who is still uncontrollable.
- Patient with active severe atopic dermatitis
- Patient who are pregnant or in lactating period
- Patient or parent deny to join in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Local and Imported Skin Prick Testing Result of Rat and Mouse Allergen Extracts in Respiratory Allergy Patients
In respiratory allergy patients, skin prick test results of local rat and mouse allergen extracts are not significant different from imported ones
Read the detailed description
Many researches proposed that rodent deteriorate symptoms in patients with respiratory allergy who sensitized. The test that can identify rodent sensitization will be very useful. The investigators found lots of problems from imported mouse and rat allergen extract, eg. expensive cost and hard to find importing agency in Thailand. Making own local allergen extract will be the good solution for the country. This study aim to compare the results of locally rat and mouse allergen to imported ones.
- Being tested
- rat and mouse skin test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rat and mouse skin testDiagnostic test
Comparison between local and imported skin prick testing result of rat and mouse allergen extracts in respiratory allergy patients
| Study group | Role | What they receive |
|---|---|---|
| Local rat and mouse skin test | Active comparator | All patients receive local skin prick test for mouse and rat. The result were recorded and compared to the imported one. Receives: Diagnostic Test: rat and mouse skin test |
| Imported rat and mouse skin test | Active comparator | All patients receive imported skin prick test for mouse and rat. The result were recorded and compared to the local one. Receives: Diagnostic Test: rat and mouse skin test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between local and imported skin prick testing result of rat and mouse allergen extracts in respiratory allergy patients
Compare the results of locally rat and mouse allergen to imported ones.
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 posted24 Aug 2018
- Study start30 May 2018
- Primary completion30 May 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Rhinitis Due to Animal Hair and DanderStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nualanong Visitsunthorn, Mahidol University
- Investigators
- Nualanong Visitsunthorn, MD, Principal investigator, Department of Pediatrics, Siriraj hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645161
- Sponsor's protocol ID
- 789/2560 (EC 2)
- Status last verified
- Aug 2019
- First submitted
- 22 Aug 2018
- Last updated
- 14 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: publication
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Local and Imported Skin Prick Testing Result of Rat and Mouse Allergen Extracts in Respiratory Allergy Patients
- ClinicalTrials.gov ID
- NCT03645161
- Acronym / sponsor ID
- 789/2560 (EC 2)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 30 May 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 24 Aug 2018 (actual)
- 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.
In respiratory allergy patients, skin prick test results of local rat and mouse allergen extracts are not significant different from imported ones
Detailed description
Many researches proposed that rodent deteriorate symptoms in patients with respiratory allergy who sensitized. The test that can identify rodent sensitization will be very useful. The investigators found lots of problems from imported mouse and rat allergen extract, eg. expensive cost and hard to find importing agency in Thailand. Making own local allergen extract will be the good solution for the country. This study aim to compare the results of locally rat and mouse allergen to imported ones.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local rat and mouse skin test | Active comparator | Diagnostic Test: rat and mouse skin testAll patients receive local skin prick test for mouse and rat. The result were recorded and compared to the imported one. |
| Imported rat and mouse skin test | Active comparator | Diagnostic Test: rat and mouse skin testAll patients receive imported skin prick test for mouse and rat. The result were recorded and compared to the local one. |
Who may qualify
- Ages
- 3 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients age 3 to 60 years old who diagnosed with asthma or allergic rhinitis
- Patient must not take these following medication at least 7 days before doing the skin prick test: antihistamine, oral corticosteroid (more than 20 mg/day of prednisolone), topical steroid that was apply on skin test area.
Key exclusion criteria (5 listed)
- Pateints who have other chronic underlying disease e.g. obesity, heart disease and liver disease
- Patient with allergic asthma who is still uncontrollable.
- Patient with active severe atopic dermatitis
- Patient who are pregnant or in lactating period
- Patient or parent deny to join in the study
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 |
|---|---|---|
| rat and mouse skin testComparison between local and imported skin prick testing result of rat and mouse allergen extracts in respiratory allergy patients | Diagnostic test | Imported rat and mouse skin test, Local rat and mouse skin test |
Primary outcome
Comparison between local and imported skin prick testing result of rat and mouse allergen extracts in respiratory allergy patients
Time frame: 1 year
Compare the results of locally rat and mouse allergen to imported ones.
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 14 Aug 2019.
- Individual participant dataSharing planned: Undecided. publication
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.
Nualanong Visitsunthorn, MD principal investigator
Department of Pediatrics, Siriraj hospital, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rat and mouse skin test in people with Allergic Rhinitis Due to Animal Hair and Dander, 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 2 inclusion and 5 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 14 Aug 2019. 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?
Comparison between local and imported skin prick testing result of rat and mouse allergen extracts in respiratory allergy patients (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 14 Aug 2019; AzTrials last refreshed its copy on 31 Oct 2026.