Aspirin SensitivityNCT03849625
Characteristics of Patients Diagnosed With NSAID Sensitivity in Thailand
An observational study of Aspirin Sensitivity and Aspirin-exacerbated Respiratory Disease, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
Study clinical characteristics and phenotypes of patients diagnosed with NSAID sensitivity in Thailand Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Aspirin Sensitivity, Aspirin-exacerbated Respiratory Disease, Aspirin-Induced Angioedema-Urticaria
- What is being tested?
- aspirin, NSAIDs, paracetamol
- How many people
- 158 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2015to 31 Mar 2020
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients at least 15 years of age with a history of an immediate reaction to aspirin/paracetamol, or NSAIDs
Who may be able to join
- Thai patients with a history of an immediate reaction to aspirin/paracetamol, or NSAIDs visiting King Chulalongkorn memorial Hospital
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Study clinical characteristics and phenotypes of patients diagnosed with NSAID sensitivity in Thailand
- Conditions
- Aspirin Sensitivity, Aspirin-exacerbated Respiratory Disease, Aspirin-Induced Angioedema-Urticaria, Aspirin Allergy, NSAID-Induced Asthma, NSAID-Induced Angioedema-Urticaria
- Being tested
- aspirin, NSAIDs, paracetamol
- Medical subject headings
- Asthma, Aspirin-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirin, NSAIDs, paracetamolDrug
Perform skin test and/or provocation test with aspirin, paracetmol, or suspected NSAIDs in questionable cases
| Study group | Role | What they receive |
|---|---|---|
| NSAID sensitivity | Patients diagnosed with an immediate reaction to aspirin/NSAIDs/or paracetamol Receives: Drug: aspirin, NSAIDs, paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of skin test/provocation test
Positive, negative, or equivocal
Measured: 4 years
Secondary outcomes (2)
Phenotypes of allergic reactions
Measured: 4 years
Urine leukotriene E4
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 May 2015
- Primary completion28 Feb 2020
- Study completion31 Mar 2020
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 Aspirin SensitivityStudies of the same condition, open and under way.
- More trials run by Chulalongkorn 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assoc. Prof. Jettanong Klaewsongkram, MD., Chulalongkorn University
- Investigators
- Jettanong Klaewsongkram, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849625
- Sponsor's protocol ID
- Chula-ARC 002/13
- Status last verified
- Feb 2022
- First submitted
- 20 Feb 2019
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klaewsongkram J, Buranapraditkun S, Mongkolpathumrat P, Palapinyo S, Chantaphakul H. Clinical Characteristics, Urinary Leukotriene E4 Levels, and Aspirin Desensitization Results in Patients With NSAID-Induced Blended Reactions. Allergy Asthma Immunol Res. 2021 Mar;13(2):229-244. doi: 10.4168/aair.2021.13.2.229.
PubMed 33474858
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Patients Diagnosed With NSAID Sensitivity in Thailand
- ClinicalTrials.gov ID
- NCT03849625
- Acronym / sponsor ID
- Chula-ARC 002/13
- Conditions
- Aspirin Sensitivity, Aspirin-exacerbated Respiratory Disease, Aspirin-Induced Angioedema-Urticaria, Aspirin Allergy, NSAID-Induced Asthma, NSAID-Induced Angioedema-Urticaria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 21 Feb 2019 (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.
Study clinical characteristics and phenotypes of patients diagnosed with NSAID sensitivity in Thailand
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSAID sensitivity | – | Drug: aspirin, NSAIDs, paracetamolPatients diagnosed with an immediate reaction to aspirin/NSAIDs/or paracetamol |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients at least 15 years of age with a history of an immediate reaction to aspirin/paracetamol, or NSAIDs
Key inclusion criteria (1 listed)
- Thai patients with a history of an immediate reaction to aspirin/paracetamol, or NSAIDs visiting King Chulalongkorn memorial Hospital
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| aspirin, NSAIDs, paracetamolPerform skin test and/or provocation test with aspirin, paracetmol, or suspected NSAIDs in questionable cases | Drug | NSAID sensitivity |
Primary outcome
Results of skin test/provocation test
Time frame: 4 years
Positive, negative, or equivocal
2 secondary outcomes
Phenotypes of allergic reactions
Time frame: 4 years
Urine leukotriene E4
Time frame: 4 years
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 25 Feb 2022.
- Results publication: PubMed 33474858Klaewsongkram J, Buranapraditkun S, Mongkolpathumrat P, Palapinyo S, Chantaphakul H. Clinical Characteristics, Urinary Leukotriene E4 Levels, and Aspirin Desensitization Results in Patients With NSAID-Induced Blended Reactions. Allergy Asthma Immunol Res. 2021 Mar;13(2):229-244. doi: 10.4168/aair.2021.13.2.229.
- Individual participant dataSharing planned: No
Related trials for Aspirin Sensitivity
Active, not recruitingPhase 2
Mechanisms of Benefit of IL4RA Inhibition in Aspirin-Exacerbated Respiratory Disease
Nasal Polyps, Asthma, Aspirin-Induced
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.
Jettanong Klaewsongkram, MD principal investigator
Chulalongkorn 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 Aspirin Sensitivity and Aspirin-exacerbated Respiratory Disease, run by Chulalongkorn 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 25 Feb 2022. 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?
Results of skin test/provocation test (time frame: 4 years). 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 NCT03849625, 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 25 Feb 2022.