Drug HypersensitivityNSAIDNCT03743220
Drug Provocation Test (DPT) to Non Steroidal Anti-inflammatory Drugs (NSAID)
An observational study of Drug Hypersensitivity, run by University Hospital, Montpellier at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drug Hypersensitivity
- How many people
- 311 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2018to 30 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient consulting in our allergy unit for a suspicion of drug hypersensitivity to non steroidal anti inflammatory drug (s) and who underwent DPT.
Who may be able to join
- Patients with one or more positives DPT to NSAIDs
Who cannot join
- Patients refusing to take part in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Construction and Validation of a Simplified Provocation Tests for the Diagnosis of Non Steroidal Anti-inflammatory Drugs (NSAID) Hypersensitivity
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).
Read the 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.
- Conditions
- Drug Hypersensitivity
- Keywords
- Drug Hypersensitivity Reaction, Drug Provocation Test, Non steroidal Anti Inflammatory drugs, Reactive Doses, Reactive Times
- Medical subject headings
- Drug Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect eliciting dose thresholds during NSAIDs DPT optimal step doses
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
Measured: 1 day
Secondary outcomes (1)
Describe subgroups at higher risk during the DPT
Identifying the independent variables (predictive factors), using the multivariate linear regression method, that remains significantly associated with a positive NSAIDs DPT
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start1 Dec 2018
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug HypersensitivityStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal DEMOLY, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743220
- Sponsor's protocol ID
- RECHMPL18_0433
- Acronym
- NSAID
- Status last verified
- Mar 2020
- First submitted
- 13 Nov 2018
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Validation of a Simplified Provocation Tests for the Diagnosis of Non Steroidal Anti-inflammatory Drugs (NSAID) Hypersensitivity
- ClinicalTrials.gov ID
- NCT03743220
- Acronym / sponsor ID
- NSAID / RECHMPL18_0433
- Conditions
- Drug Hypersensitivity
- Keywords
- Drug Hypersensitivity Reaction, Drug Provocation Test, Non steroidal Anti Inflammatory drugs, Reactive Doses, Reactive Times
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient consulting in our allergy unit for a suspicion of drug hypersensitivity to non steroidal anti inflammatory drug (s) and who underwent DPT.
Key inclusion criteria (1 listed)
- Patients with one or more positives DPT to NSAIDs
Key exclusion criteria (1 listed)
- Patients refusing to take part in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Describe subgroups at higher risk during the DPT
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Drug Hypersensitivity
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Active, not recruitingPhase 2/3
Efficacy and Safety of Obinutuzumab Versus Rituximab in Childhood Steroid Dependant and Frequent Relapsing Nephrotic Syndrome
Steroid-Dependent Nephrotic Syndrome, Steroid-Sensitive Nephrotic Syndrome
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
RecruitingPhase 3
A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema
Atopic Dermatitis
RecruitingPhase 2
A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema
Atopic Dermatitis, Eczema, Atopic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal DEMOLY, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Hypersensitivity, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect eliciting dose thresholds during NSAIDs DPT optimal step doses (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.