Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-01-11 @ 5:33 PM
Study NCT ID:
NCT03743220
Status:
COMPLETED
Last Update Posted:
2020-03-10
First Post:
2018-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Provocation Test (DPT) to Non Steroidal Anti-inflammatory Drugs (NSAID)
Sponsor:
University Hospital, Montpellier
Organization:
Study Overview
Official Title:
Construction and Validation of a Simplified Provocation Tests for the Diagnosis of Non Steroidal Anti-inflammatory Drugs (NSAID) Hypersensitivity
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NSAID
Brief Summary:
Background : Non steroidal anti-inflammatory drugs are responsible for 25% of reported adverse drug events which include immunological and non-immunological hypersensitivity reactions. NSAIDs have been reported to be the second most common cause of drug-induced hypersensitivity reaction (DHR). They are almost mandatory in a human life and therefore, the drug allergy work-up goes up until a DPT in order to confirm or rule out the diagnosis.
Objective: Detect eliciting dose thresholds during NSAIDs DPT in order to suggest optimal step doses and to describe subgroups at higher risk during the DPT
Methods:This retrospective study, using the survival analysis, comprised all patients who attended the allergy service of the UH of Montpellier from 1997 till 2017 with a clinical history related to NSAIDs DHR, who underwent NDAIDs DPT that turned positive and who gave their consent to be included in the study . The Patients are selected from the Drug Allergy \& Hypersensitivity Database (DAHD).
Objective: Detect eliciting dose thresholds during NSAIDs DPT in order to suggest optimal step doses and to describe subgroups at higher risk during the DPT
Methods:This retrospective study, using the survival analysis, comprised all patients who attended the allergy service of the UH of Montpellier from 1997 till 2017 with a clinical history related to NSAIDs DHR, who underwent NDAIDs DPT that turned positive and who gave their consent to be included in the study . The Patients are selected from the Drug Allergy \& Hypersensitivity Database (DAHD).
Detailed Description:
DHRs to NSAIDs may be induced by both specific immunological mechanisms and mechanisms not based on immunological recognition (cross-hypersensitivity reactions \[CRs\]) .They are almost mandatory in a human life and therefore, the drug allergy work-up goes up until a DPT in order to confirm or rule out the diagnosis. Although the overall prevalence of NSAID hypersensitivity has been reported between 0.6 and 7% of the general population .
The NSAIDs-induced hypersensitivity reactions involve different mechanisms and present a wide range of clinical manifestations from anaphylaxis or severe bronchospasm developing within minutes after drug ingestion to non-immediate responses appearing after days and weeks This data-driven approach in designing the DPT protocol is the second step in improving DPT standardization, after BL antibiotics.
The NSAIDs-induced hypersensitivity reactions involve different mechanisms and present a wide range of clinical manifestations from anaphylaxis or severe bronchospasm developing within minutes after drug ingestion to non-immediate responses appearing after days and weeks This data-driven approach in designing the DPT protocol is the second step in improving DPT standardization, after BL antibiotics.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: