- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00815126
Nasal Provocation Test With Lysine-Acetylsalicylate (ASA) in Patients With Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Hypersensitivity
November 17, 2010 updated by: Chulalongkorn University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bangkok, Thailand, 10330
- Faculty of Medicine, Chulalongkorn University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with history of ASA/NSAIDs hypersensitivity with mucocutaneous symptoms and/or respiratory symptoms
Exclusion Criteria:
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Mucocutaneous symptoms from NSAIDs
|
Lysine-ASA 80 µl (16 mg of aspirin) will be installed in both nostrils with pipette
|
Active Comparator: Respiratory symptoms from NSAIDs
|
Lysine-ASA 80 µl (16 mg of aspirin) will be installed in both nostrils with pipette
|
Active Comparator: NSAIDs tolerant individuals
|
Lysine-ASA 80 µl (16 mg of aspirin) will be installed in both nostrils with pipette
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation between clinical manifestations and laboratory results (basophil activation test, etc.)
Time Frame: 5 months
|
5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jettanong Klaewsongkram, MD, Chulalongkorn University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
December 26, 2008
First Submitted That Met QC Criteria
December 26, 2008
First Posted (Estimate)
December 29, 2008
Study Record Updates
Last Update Posted (Estimate)
November 18, 2010
Last Update Submitted That Met QC Criteria
November 17, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Chula-ARC 002/08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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