Characteristics of Patients Diagnosed With NSAID Sensitivity in Thailand

• Sponsor: Chulalongkorn University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03849625
• Collaborator: (none)
• Enrollment: 158
• Location: 1
• Actual Duration (Months): 59
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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

Study Design

• Study Type: Observational
• Actual Enrollment: 158 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Characteristics of Patients Diagnosed With NSAID Sensitivity in Thailand
• Actual Study Start Date: May 1, 2015
• Actual Primary Completion Date: Feb 28, 2020
• Actual Study Completion Date: Mar 31, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Results of skin test/provocation test [4 years]

   Positive, negative, or equivocal

Secondary Outcome Measures

1. Phenotypes of allergic reactions [4 years]

2. Urine leukotriene E4 [4 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Chulalongkorn University	Bangkok		Thailand	10330

Sponsors and Collaborators

• Chulalongkorn University

Investigators

• Principal Investigator: Jettanong Klaewsongkram, MD, Chulalongkorn University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assoc. Prof. Jettanong Klaewsongkram, MD., Assoc. Prof. Jettanong Klaewsongkram, MD., Chulalongkorn University
• ClinicalTrials.gov Identifier: NCT03849625
• Other Study ID Numbers: Chula-ARC 002/13
• First Posted: Feb 21, 2019
• Last Update Posted: Feb 25, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Respiration Disorders; Respiratory Tract Diseases; Asthma, Aspirin-Induced; Angioedema; Urticaria; Hypersensitivity; Anaphylaxis; Shock; Aspirin; Acetaminophen

Study Results

No Results Posted as of Feb 25, 2022