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Characteristics of Patients Diagnosed With NSAID Sensitivity in Thailand

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ClinicalTrials.gov Identifier: NCT03849625
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Assoc. Prof. Jettanong Klaewsongkram, MD., Chulalongkorn University

Brief Summary:
Study clinical characteristics and phenotypes of patients diagnosed with NSAID sensitivity in Thailand

Condition or disease Intervention/treatment
Aspirin Sensitivity Aspirin-exacerbated Respiratory Disease Aspirin-Induced Angioedema-Urticaria Aspirin Allergy NSAID-Induced Asthma NSAID-Induced Angioedema-Urticaria NSAID-Induced Anaphylactoid Reaction Aspirin-Induced Anaphylactoid Reaction Drug: aspirin, NSAIDs, paracetamol

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characteristics of Patients Diagnosed With NSAID Sensitivity in Thailand
Actual Study Start Date : July 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Aspirin

Group/Cohort Intervention/treatment
NSAID sensitivity
Patients diagnosed with an immediate reaction to aspirin/NSAIDs/or paracetamol
Drug: aspirin, NSAIDs, paracetamol
Perform skin test and/or provocation test with aspirin, paracetmol, or suspected NSAIDs in questionable cases




Primary Outcome Measures :
  1. Results of skin test/provocation test [ Time Frame: 4 years ]
    Positive, negative, or equivocal


Secondary Outcome Measures :
  1. Phenotypes of allergic reactions [ Time Frame: 4 years ]
  2. Urine leukotriene E4 [ Time Frame: 4 years ]

Biospecimen Retention:   Samples With DNA
Sputum, urine


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at least 15 years of age with a history of an immediate reaction to aspirin/paracetamol, or NSAIDs
Criteria

Inclusion Criteria:

  • Thai patients with a history of an immediate reaction to aspirin/paracetamol, or NSAIDs visiting King Chulalongkorn memorial Hospital

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03849625


Contacts
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Contact: Jettanong Klaewsongkram, MD Jettanong.K@chula.ac.th

Locations
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Thailand
Faculty of Medicine, Chulalongkorn University Recruiting
Bangkok, Thailand, 10330
Contact: Jettanong Klaewsongkram, MD    662-2564152    Jettanong.K@chula.ac.th   
Principal Investigator: Jettanong Klaewsongkram, MD         
Sponsors and Collaborators
Chulalongkorn University
Investigators
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Principal Investigator: Jettanong Klaewsongkram, MD Chulalongkorn University

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Responsible Party: Assoc. Prof. Jettanong Klaewsongkram, MD., Chulalongkorn University
ClinicalTrials.gov Identifier: NCT03849625     History of Changes
Other Study ID Numbers: Chula-ARC 002/13
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypersensitivity
Hypersensitivity, Immediate
Respiratory Hypersensitivity
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Respiration Disorders
Asthma, Aspirin-Induced
Angioedema
Urticaria
Respiratory Tract Diseases
Immune System Diseases
Skin Diseases, Vascular
Skin Diseases
Vascular Diseases
Cardiovascular Diseases
Asthma
Bronchial Diseases
Chemically-Induced Disorders
Aspirin
Acetaminophen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents