Aspirin HypersensitivityNCT00815126
Nasal Provocation Test With Lysine-Acetylsalicylate (ASA) in Patients With Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Hypersensitivity
A study testing Lysine-ASA Nasal ProvocationTest in people with Aspirin Hypersensitivity and NSAIDs Hypersensitivity, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
This study aims to compare the efficacy of nasal provocation test with Lysine-Acetylsalicylate in patients with history of NSAIDs hypersensitivity between mucocutaneous symptoms and respiratory symptoms and laboratory outcomes. Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Aspirin Hypersensitivity, NSAIDs Hypersensitivity
- What is being tested?
- Lysine-ASA Nasal ProvocationTest
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2008to Apr 2009
- 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 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with history of ASA/NSAIDs hypersensitivity with mucocutaneous symptoms and/or respiratory symptoms
Who cannot join
- Patients who cannot discontinue drugs before the test as follow
- Nasal corticosteroids/Oral corticosteroids/Leukotriene modifiers for 1 week
- Short-acting antihistamines for 3 days
- Nasal a-mimetics/Oral a-mimetics/Local cromones for 24 hours
- Contraindicated for nasal provocation test: pregnant, exacerbation of allergic rhinitis/asthma, having upper respiratory tract infection within 2 weeks prior to the test, having nose surgery within 8 weeks prior to the test, having severe systemic disease(s)
- Having factors interfere nasal provocation test with Lysine-ASA such as massive nasal polyp, nasal septal perforation, total nasal obstruction at least 1 nostril
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Nasal Provocation Test With Lysine-Acetylsalicylate(ASA) and Clinical Diagnosis in Patients With Aspirin/Nonsteroidal Anti-Inflammatory Drugs(NSAIDs) and/or Acetaminophen Immediate Sensitivity Reactions
This study aims to compare the efficacy of nasal provocation test with Lysine-Acetylsalicylate in patients with history of NSAIDs hypersensitivity between mucocutaneous symptoms and respiratory symptoms and laboratory outcomes.
- Conditions
- Aspirin Hypersensitivity, NSAIDs Hypersensitivity
- Being tested
- Lysine-ASA Nasal ProvocationTest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lysine-ASA Nasal ProvocationTestProcedure or surgery
Lysine-ASA 80 µl (16 mg of aspirin) will be installed in both nostrils with pipette
| Study group | Role | What they receive |
|---|---|---|
| Mucocutaneous symptoms from NSAIDs | Active comparator | Not described Receives: Procedure: Lysine-ASA Nasal ProvocationTest |
| Respiratory symptoms from NSAIDs | Active comparator | Not described Receives: Procedure: Lysine-ASA Nasal ProvocationTest |
| NSAIDs tolerant individuals | Active comparator | Not described Receives: Procedure: Lysine-ASA Nasal ProvocationTest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom scores and/or acoustic rhinometry result upon Lysine-ASA nasal provocation test in patients with history of mucocutaneous or respiratory symptoms from NSAIDs
Measured: 5 months
Secondary outcomes (1)
Correlation between clinical manifestations and laboratory results (basophil activation test, etc.)
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionMar 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspirin HypersensitivityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Investigators
- Jettanong Klaewsongkram, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815126
- Sponsor's protocol ID
- Chula-ARC 002/08
- Status last verified
- Nov 2010
- First submitted
- 26 Dec 2008
- Last updated
- 18 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Nasal Provocation Test With Lysine-Acetylsalicylate(ASA) and Clinical Diagnosis in Patients With Aspirin/Nonsteroidal Anti-Inflammatory Drugs(NSAIDs) and/or Acetaminophen Immediate Sensitivity Reactions
- ClinicalTrials.gov ID
- NCT00815126
- Acronym / sponsor ID
- Chula-ARC 002/08
- Conditions
- Aspirin Hypersensitivity, NSAIDs Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 29 Dec 2008 (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.
This study aims to compare the efficacy of nasal provocation test with Lysine-Acetylsalicylate in patients with history of NSAIDs hypersensitivity between mucocutaneous symptoms and respiratory symptoms and laboratory outcomes.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mucocutaneous symptoms from NSAIDs | Active comparator | Procedure: Lysine-ASA Nasal ProvocationTest |
| Respiratory symptoms from NSAIDs | Active comparator | Procedure: Lysine-ASA Nasal ProvocationTest |
| NSAIDs tolerant individuals | Active comparator | Procedure: Lysine-ASA Nasal ProvocationTest |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with history of ASA/NSAIDs hypersensitivity with mucocutaneous symptoms and/or respiratory symptoms
Key exclusion criteria (6 listed)
- Patients who cannot discontinue drugs before the test as follow
- Contraindicated for nasal provocation test: pregnant, exacerbation of allergic rhinitis/asthma, having upper respiratory tract infection within 2 weeks prior to the test, having nose surgery within 8 weeks prior to the test, having severe systemic disease(s)
- Having factors interfere nasal provocation test with Lysine-ASA such as massive nasal polyp, nasal septal perforation, total nasal obstruction at least 1 nostril
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 |
|---|---|---|
| Lysine-ASA Nasal ProvocationTestLysine-ASA 80 µl (16 mg of aspirin) will be installed in both nostrils with pipette | Procedure or surgery | Mucocutaneous symptoms from NSAIDs, NSAIDs tolerant individuals, Respiratory symptoms from NSAIDs |
Primary outcome
Symptom scores and/or acoustic rhinometry result upon Lysine-ASA nasal provocation test in patients with history of mucocutaneous or respiratory symptoms from NSAIDs
Time frame: 5 months
1 secondary outcome
Correlation between clinical manifestations and laboratory results (basophil activation test, etc.)
Time frame: 5 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 18 Nov 2010.
Related trials for Aspirin Hypersensitivity
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?
A study testing Lysine-ASA Nasal ProvocationTest in people with Aspirin Hypersensitivity and NSAIDs Hypersensitivity, 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 6 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 18 Nov 2010. 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?
Symptom scores and/or acoustic rhinometry result upon Lysine-ASA nasal provocation test in patients with history of mucocutaneous or respiratory symptoms from NSAIDs (time frame: 5 months). 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 18 Nov 2010.