Drug Provocation Test (DPT) to Non Steroidal Anti-inflammatory Drugs (NSAID) (NSAID)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03743220|
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : April 19, 2019
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).
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||311 participants|
|Official Title:||Construction and Validation of a Simplified Provocation Tests for the Diagnosis of Non Steroidal Anti-inflammatory Drugs (NSAID) Hypersensitivity|
|Actual Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||June 30, 2019|
- Detect eliciting dose thresholds during NSAIDs DPT optimal step doses [ Time Frame: 1 day ]The DPT was considered positive if objective signs occurred during NSAIDs administration. The reactive dose (RD) was calculated from the total cumulative dose (mg) reached when the DPT was considered positive
- Describe subgroups at higher risk during the DPT [ Time Frame: 1 day ]Identifying the independent variables (predictive factors), using the multivariate linear regression method, that remains significantly associated with a positive NSAIDs DPT
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): NCT03743220
|Contact: Anca CHIRIAC, MD, PhD||467336107 ext firstname.lastname@example.org|
|University hospital of Montpellier||Recruiting|
|Montpellier, France, 34295|
|Contact: Pascal DEMOLY, MD, phD +33 467336107 email@example.com|
|Contact: Anca CHIRIAC, MD, phD 46733610 ext 33 firstname.lastname@example.org|
|Principal Investigator:||Pascal DEMOLY, MD, PhD||University Hospital, Montpellier|