NCT03849625

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

4.8 years

First QC Date

February 20, 2019

Last Update Submit

February 8, 2022

Conditions

Aspirin SensitivityAspirin-exacerbated Respiratory DiseaseAspirin-Induced Angioedema-UrticariaAspirin AllergyNSAID-Induced AsthmaNSAID-Induced Angioedema-UrticariaNSAID-Induced Anaphylactoid ReactionAspirin-Induced Anaphylactoid Reaction

Outcome Measures

Primary Outcomes (1)

  • Results of skin test/provocation test

    Positive, negative, or equivocal

    4 years

Secondary Outcomes (2)

  • Phenotypes of allergic reactions

    4 years

  • Urine leukotriene E4

    4 years

Study Arms (1)

NSAID sensitivity

Patients diagnosed with an immediate reaction to aspirin/NSAIDs/or paracetamol

Drug: aspirin, NSAIDs, paracetamol

Interventions

aspirin, NSAIDs, paracetamolDRUG

Perform skin test and/or provocation test with aspirin, paracetmol, or suspected NSAIDs in questionable cases

NSAID sensitivity

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients at least 15 years of age with a history of an immediate reaction to aspirin/paracetamol, or NSAIDs

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 33474858RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sputum, urine

MeSH Terms

Conditions

Asthma, Aspirin-Induced

Interventions

AspirinAnti-Inflammatory Agents, Non-SteroidalAcetaminophen

Condition Hierarchy (Ancestors)

AsthmaBronchial DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesDrug HypersensitivityDrug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAnalgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic AgentsAcetanilidesAnilidesAmidesAniline CompoundsAmines

Study Officials

  • Jettanong Klaewsongkram, MD

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Jettanong Klaewsongkram, MD.

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 21, 2019

Study Start

May 1, 2015

Primary Completion

February 28, 2020

Study Completion

March 31, 2020

Last Updated

February 25, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)