NSAIDNSAID-ASNCT07034066
Pediatric Non-Steroidal Anti-Inflammatory Drugs (NSAID) Allergy Study
An observational study of NSAID and Biomarkers, run by Fundació Sant Joan de Déu at 1 site in Spain.
Trial summary
Non-steroidal anti-inflammatory drugs (NSAIDs) are some of the most commonly used medications to treat pain and inflammation. Many are available over the counter and are frequently used in children to reduce fever and relieve pain. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- NSAID, Biomarkers, Phenotyping
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 257 participants
- Where
- 1 siteSpain
- Study dates
- 15 Mar 2022to 1 May 2025
- How long will I take part?
- 11 Years
- 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 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population consists of pediatric patients (aged 0 to 17 years) with a clinical suspicion or confirmed diagnosis of hypersensitivity NSAID. Retrospective Cohort: Includes all patients who underwent at least one drug provocation test (DPT) for suspected NSAID hypersensitivity between January 2014 and December 2021 at the Pediatric Allergy Department of Hospital Sant Joan de Déu. Prospective Cohort: Includes newly referred patients to the outpatient Pediatric Allergy Clinic from August 2022 to December 2024, presenting with clinical symptoms suggestive of NSAID hypersensitivity. Eligibility is determined based on: * Clinical manifestations (cutaneous and/or respiratory) following NSAID intake. * A high likelihood of an adverse drug reaction based on history. * Informed consent signed by parents or legal guardians. * Patients with incomplete DPTs or those whose guardians decline consent (for the prospective arm) are excluded.
Who may be able to join
- Children aged 0-17 years
- Completed DPT with the suspected and/or alternative NSAID
Who cannot join
- Patients who did not undergo or complete the DPT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) in Pediatric Population
Non-steroidal anti-inflammatory drugs (NSAIDs) are some of the most commonly used medications to treat pain and inflammation. Many are available over the counter and are frequently used in children to reduce fever and relieve pain. Hypersensitivity (HS) to NSAIDs affects an estimated 0.6% to 5.7% of the general population. These reactions can be caused by immune or non-immune mechanisms. In most cases, they fall into two categories: reactions to a single NSAID or to several different NSAIDs.
Currently, the main way to diagnose NSAID hypersensitivity is through a drug provocation test (DPT)-this involves giving the patient the suspected drug under medical supervision to check for a reaction. It's considered the most reliable method. However, diagnosing these reactions in children can be challenging. Symptoms can vary widely, and there are few accurate alternative tests available to replace the DPT.
This study looks for easier ways-like symptoms or lab tests-to diagnose NSAID reactions, so fewer patients need to go through multiple DPT.
Read the detailed description
Hypersensitivity reactions (HSR) to NSAID in children, although similar to those in adults, present unique challenges in terms of diagnosis and management. While international classification systems are useful, real-world clinical scenarios often fall outside established criteria. Examples include:
- Multiple NSAID HSR involving both cutaneous and respiratory symptoms.
- NSAID-induced anaphylaxis dependent on food intake.
- Immediate selective reactions to more than one NSAID. These scenarios are frequently observed in pediatric patients, highlighting the need for a regional study to evaluate and properly address them.
This is a single-center, ambispective observational study.
Primary Objective:
To describe the clinical characteristics of children with NSAID hypersensitivity.
Secondary Objectives:
- To describe the different clinical phenotypes and assess age-related differences.
- To assess tolerance to alternative NSAIDs in patients with confirmed hypersensitivity.
- To evaluate the usefulness of in vivo and in vitro tests in the diagnostic process.
- To disseminate study findings.
The study design is based on 2 components:
- Retrospective Component: include participants diagnosed with NSAID HSR, who underwent DPT in the Pediatric Allergy Department at Hospital Sant Joan de Déu between January 2014 and December 2021. Data will be pseudonymized. A waiver of informed consent will be requested due to the long study period, the absence of risk, and the fact that many patients are no longer under follow-up.
- Prospective Component: participants with suspected NSAID HSR were included. Participants will be assessed during outpatient visits, where the following steps will occur:
- In vivo testing, where appropriate, using validated prick and intradermal techniques for paracetamol and metamizole. Controls will include saline (negative) and histamine (positive).
- A DPT will be performed with the suspected medication and/or suitable alternatives, in accordance with standard clinical practice.
- Nasal DPT using a rhinomanometer for patients suspected of NSAID-exacerbated respiratory disease (NERD).
- Families will be informed about the procedures, and informed consent will be obtained.
On the day of the DPT, a blood test (including total IgE, IgG, IgA, IgM, tryptase, IL-6) and urine sample (uLTE4 levels) will be collected.
If the DPT is positive, a second round of blood and urine samples will be collected.
The NSAID to be used in testing are commonly prescribed in pediatric practice and grouped by chemical structure:
Salicylic acid derivatives: Aspirin Para-aminophenol derivatives: Paracetamol (acetaminophen) Propionic acid derivatives: Ibuprofen, naproxen Acetic acid derivatives: Diclofenac Enolic acid derivatives: Pyrazolones, oxicams Fenamates (fenamic acid derivatives) COX-2 inhibitors: Celecoxib
- Conditions
- NSAID, Biomarkers, Phenotyping, Children
- Keywords
- NSAID-hipersensitivity in children, children drug allergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Cohort | Includes new patients referred to the Pediatric Allergy outpatient clinic with suspected NSAID hypersensitivity. Inclusion Criteria: Children aged 0-17 years Clinical suspicion of NSAID hypersensitivity Exclusion Criteria: Refusal to provide informed consent At the first outpatient visit: A complete medical history and physical exam will be performed The need for DPT (oral/nasal) will be explained to the family Informed consent will be obtained On admission for oral DPT: blood and urine samples will be collected DPT will be conducted via oral route unless the original reaction occurred after intravenous administration Positive DPTs will be followed by sample collection and symptom management A follow-up phone call will be made within 6 months to assess home tolerance For patients undergoing nasal DPT, the test will be conducted in the hospital's ENT unit, and follow-up will depend on the result. | |
| Retrospective Cohort | Includes all patients who underwent a DPT for NSAID hypersensitivity between 2014 and 2021 in the Pediatric Allergy Unit. Inclusion Criteria: Children aged 0-17 years Completed DPT with the suspected and/or alternative NSAID Exclusion Criteria: Patients who did not undergo or complete the DPT Upon protocol approval, data on all hospital admissions related to NSAID hypersensitivity evaluation (2014-2021) will be requested. Clinical records will be reviewed after pseudonymization, which will be performed by an independent individual, Ms. Silvia del Valle, who will also safeguard the pseudonymization key. This complies with legal requirements for accessing medical records without consent, under CEIm approval, including: Functional and technical separation between investigators and data processors Explicit confidentiality and non-reidentification commitment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical characteristics of pediatric patients with NSAID hypersensitivity, based on historical data and development of a diagnostic protocol.
In both the retrospective and prospective arm, the investigators reviewed the medical records of patients who completed DPT. Participant demographic data were reviewed, including age, sex, personal and family history of atopy, and the results of DPTs performed on suspected medications and alternatives if necessary.
Final phenotypes after DPT were:
- Cross-intolerance (CI)
- Selective hypersensitivity (SH)
Measured: Retrospective arm: review of the medical records took about 4-6 months Prospective arm: from enrollment to DPT, 6-8 months.
Secondary outcomes (3)
Differences in clinical features across different pediatric age groups.
In both the retrospective and prospective groups, factors that may predispose to having a confirmed HS based on the clinical history will be analyzed: sex, age, history of atopy, angioedema, rash/urticaria, reason for which the drug is prescribed, having presented more than 1 reaction with the same drug or different NSAIDs.
Measured: Retrospective arm: review of the medical records took about 4-6 months Prospective arm: from enrollment to DPT, 6-8 months.
Rate of tolerance to alternative NSAIDs among patients with confirmed hypersensitivity.
In the retrospective arm, in participants with cross-intolerance, all tolerated high-dose paracetamol and COX-2 inhibitors (meloxicam). Those with selective NSAID HS were tested for tolerance to alternatives from other groups as appropriate.
In the prospective arm, the investigators do not yet have results.
Measured: Retrospective arm: review of the medical records took about 4-6 months Prospective arm: from enrollment to DPT, 6-8 months.
Diagnostic performance of in vivo and in vitro tests.
Both in vivo and in vitro testing were performed in the prospective arm, and DPT is still pending, so the investigators are waiting to complete this in order to analyze the results.
Measured: Prospective arm: from enrollment to DPT, 6-8 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start15 Mar 2022
- Primary completion30 Dec 2024
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for NSAIDStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 257 participants (actual)
- Target duration
- 11 Years
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Sant Joan de Deu
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034066
- Sponsor's protocol ID
- Sant Joan de Deu Foundation
- Acronym
- NSAID-AS
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available beginning 6 months after publication and will remain accessible for 5 years. The results will be available in clinicaltrials.gov with supporting information (Clinical Study Report (CSR)).
Publications
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.
PubMed 33474858Dona I, Saenz de Santa Maria R, Moreno EM, Bartra J, Torres MJ. An algorithm for the diagnosis and treatment of nonsteroidal antiinflammatory drugs hypersensitivity, 2024 update. Allergy. 2025 Apr;80(4):1183-1186. doi: 10.1111/all.16349. Epub 2024 Oct 4. No abstract available.
PubMed 39365158Blanca-Lopez N, Haroun-Diaz E, Ruano FJ, Perez-Alzate D, Somoza ML, Vazquez de la Torre Gaspar M, Rivas-Ruiz F, Garcia-Martin E, Blanca M, Canto G. Acetyl Salicylic Acid Challenge in Children with Hypersensitivity Reactions to Nonsteroidal Anti-Inflammatory Drugs Differentiates Between Cross-Intolerant and Selective Responders. J Allergy Clin Immunol Pract. 2018 Jul-Aug;6(4):1226-1235. doi: 10.1016/j.jaip.2017.08.029. Epub 2017 Oct 3.
PubMed 28986120Cavkaytar O, Arga M. NSAID Hypersensitivity in the Pediatric Population: Classification and Diagnostic Strategies. J Asthma Allergy. 2022 Sep 28;15:1383-1399. doi: 10.2147/JAA.S267005. eCollection 2022.
PubMed 36199560Kidon M, Blanca-Lopez N, Gomes E, Terreehorst I, Tanno L, Ponvert C, Chin CW, Caubet JC, Soyer O, Mori F, Blanca M, Atanaskovic-Markovic M. EAACI/ENDA Position Paper: Diagnosis and management of hypersensitivity reactions to non-steroidal anti-inflammatory drugs (NSAIDs) in children and adolescents. Pediatr Allergy Immunol. 2018 Aug;29(5):469-480. doi: 10.1111/pai.12915. Epub 2018 Jun 13.
PubMed 29693290
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) in Pediatric Population
- ClinicalTrials.gov ID
- NCT07034066
- Acronym / sponsor ID
- NSAID-AS / Sant Joan de Deu Foundation
- Conditions
- NSAID, Biomarkers, Phenotyping, Children
- Keywords
- NSAID-hipersensitivity in children, children drug allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- Hospital Sant Joan de Deu
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 24 Jun 2025 (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.
Non-steroidal anti-inflammatory drugs (NSAIDs) are some of the most commonly used medications to treat pain and inflammation. Many are available over the counter and are frequently used in children to reduce fever and relieve pain. Hypersensitivity (HS) to NSAIDs affects an estimated 0.6% to 5.7% of the general population. These reactions can be caused by immune or non-immune mechanisms. In most cases, they fall into two categories: reactions to a single NSAID or to several different NSAIDs.
Currently, the main way to diagnose NSAID hypersensitivity is through a drug provocation test (DPT)-this involves giving the patient the suspected drug under medical supervision to check for a reaction. It's considered the most reliable method. However, diagnosing these reactions in children can be challenging. Symptoms can vary widely, and there are few accurate alternative tests available to replace the DPT.
This study looks for easier ways-like symptoms or lab tests-to diagnose NSAID reactions, so fewer patients need to go through multiple DPT.
Detailed description
Hypersensitivity reactions (HSR) to NSAID in children, although similar to those in adults, present unique challenges in terms of diagnosis and management. While international classification systems are useful, real-world clinical scenarios often fall outside established criteria. Examples include:
- Multiple NSAID HSR involving both cutaneous and respiratory symptoms.
- NSAID-induced anaphylaxis dependent on food intake.
- Immediate selective reactions to more than one NSAID. These scenarios are frequently observed in pediatric patients, highlighting the need for a regional study to evaluate and properly address them.
This is a single-center, ambispective observational study.
Primary Objective:
To describe the clinical characteristics of children with NSAID hypersensitivity.
Secondary Objectives:
- To describe the different clinical phenotypes and assess age-related differences.
- To assess tolerance to alternative NSAIDs in patients with confirmed hypersensitivity.
- To evaluate the usefulness of in vivo and in vitro tests in the diagnostic process.
- To disseminate study findings.
The study design is based on 2 components:
- Retrospective Component: include participants diagnosed with NSAID HSR, who underwent DPT in the Pediatric Allergy Department at Hospital Sant Joan de Déu between January 2014 and December 2021. Data will be pseudonymized. A waiver of informed consent will be requested due to the long study period, the absence of risk, and the fact that many patients are no longer under follow-up.
- Prospective Component: participants with suspected NSAID HSR were included. Participants will be assessed during outpatient visits, where the following steps will occur:
- In vivo testing, where appropriate, using validated prick and intradermal techniques for paracetamol and metamizole. Controls will include saline (negative) and histamine (positive).
- A DPT will be performed with the suspected medication and/or suitable alternatives, in accordance with standard clinical practice.
- Nasal DPT using a rhinomanometer for patients suspected of NSAID-exacerbated respiratory disease (NERD).
- Families will be informed about the procedures, and informed consent will be obtained.
On the day of the DPT, a blood test (including total IgE, IgG, IgA, IgM, tryptase, IL-6) and urine sample (uLTE4 levels) will be collected.
If the DPT is positive, a second round of blood and urine samples will be collected.
The NSAID to be used in testing are commonly prescribed in pediatric practice and grouped by chemical structure:
Salicylic acid derivatives: Aspirin Para-aminophenol derivatives: Paracetamol (acetaminophen) Propionic acid derivatives: Ibuprofen, naproxen Acetic acid derivatives: Diclofenac Enolic acid derivatives: Pyrazolones, oxicams Fenamates (fenamic acid derivatives) COX-2 inhibitors: Celecoxib
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 11 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort | – | –Includes new patients referred to the Pediatric Allergy outpatient clinic with suspected NSAID hypersensitivity. Inclusion Criteria: Children aged 0-17 years Clinical suspicion of NSAID hypersensitivity Exclusion Criteria: Refusal to provide informed consent At the first outpatient visit: A complete medical history and physical exam will be performed The need for DPT (oral/nasal) will be explained to the family Informed consent will be obtained On admission for oral DPT: blood and urine samples will be collected DPT will be conducted via oral route unless the original reaction occurred after intravenous administration Positive DPTs will be followed by sample collection and symptom management A follow-up phone call will be made within 6 months to assess home tolerance For patients undergoing nasal DPT, the test will be conducted in the hospital's ENT unit, and follow-up will depend on the result. |
| Retrospective Cohort | – | –Includes all patients who underwent a DPT for NSAID hypersensitivity between 2014 and 2021 in the Pediatric Allergy Unit. Inclusion Criteria: Children aged 0-17 years Completed DPT with the suspected and/or alternative NSAID Exclusion Criteria: Patients who did not undergo or complete the DPT Upon protocol approval, data on all hospital admissions related to NSAID hypersensitivity evaluation (2014-2021) will be requested. Clinical records will be reviewed after pseudonymization, which will be performed by an independent individual, Ms. Silvia del Valle, who will also safeguard the pseudonymization key. This complies with legal requirements for accessing medical records without consent, under CEIm approval, including: Functional and technical separation between investigators and data processors Explicit confidentiality and non-reidentification commitment |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population consists of pediatric patients (aged 0 to 17 years) with a clinical suspicion or confirmed diagnosis of hypersensitivity NSAID. Retrospective Cohort: Includes all patients who underwent at least one drug provocation test (DPT) for suspected NSAID hypersensitivity between January 2014 and December 2021 at the Pediatric Allergy Department of Hospital Sant Joan de Déu. Prospective Cohort: Includes newly referred patients to the outpatient Pediatric Allergy Clinic from August 2022 to December 2024, presenting with clinical symptoms suggestive of NSAID hypersensitivity. Eligibility is determined based on: * Clinical manifestations (cutaneous and/or respiratory) following NSAID intake. * A high likelihood of an adverse drug reaction based on history. * Informed consent signed by parents or legal guardians. * Patients with incomplete DPTs or those whose guardians decline consent (for the prospective arm) are excluded.
Key inclusion criteria (2 listed)
- Children aged 0-17 years
- Completed DPT with the suspected and/or alternative NSAID
Key exclusion criteria (1 listed)
- Patients who did not undergo or complete the DPT
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
Clinical characteristics of pediatric patients with NSAID hypersensitivity, based on historical data and development of a diagnostic protocol.
Time frame: Retrospective arm: review of the medical records took about 4-6 months Prospective arm: from enrollment to DPT, 6-8 months.
In both the retrospective and prospective arm, the investigators reviewed the medical records of patients who completed DPT. Participant demographic data were reviewed, including age, sex, personal and family history of atopy, and the results of DPTs performed on suspected medications and alternatives if necessary. Final phenotypes after DPT were: * Cross-intolerance (CI) * Selective hypersensitivity (SH)
3 secondary outcomes
Differences in clinical features across different pediatric age groups.
Time frame: Retrospective arm: review of the medical records took about 4-6 months Prospective arm: from enrollment to DPT, 6-8 months.
Rate of tolerance to alternative NSAIDs among patients with confirmed hypersensitivity.
Time frame: Retrospective arm: review of the medical records took about 4-6 months Prospective arm: from enrollment to DPT, 6-8 months.
Diagnostic performance of in vivo and in vitro tests.
Time frame: Prospective arm: from enrollment to DPT, 6-8 months.
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 24 Jun 2025.
- Results publication: PubMed 33474858Klaewsongkram 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.
- Results publication: PubMed 39365158Dona I, Saenz de Santa Maria R, Moreno EM, Bartra J, Torres MJ. An algorithm for the diagnosis and treatment of nonsteroidal antiinflammatory drugs hypersensitivity, 2024 update. Allergy. 2025 Apr;80(4):1183-1186. doi: 10.1111/all.16349. Epub 2024 Oct 4. No abstract available.
- Results publication: PubMed 28986120Blanca-Lopez N, Haroun-Diaz E, Ruano FJ, Perez-Alzate D, Somoza ML, Vazquez de la Torre Gaspar M, Rivas-Ruiz F, Garcia-Martin E, Blanca M, Canto G. Acetyl Salicylic Acid Challenge in Children with Hypersensitivity Reactions to Nonsteroidal Anti-Inflammatory Drugs Differentiates Between Cross-Intolerant and Selective Responders. J Allergy Clin Immunol Pract. 2018 Jul-Aug;6(4):1226-1235. doi: 10.1016/j.jaip.2017.08.029. Epub 2017 Oct 3.
- Results publication: PubMed 36199560Cavkaytar O, Arga M. NSAID Hypersensitivity in the Pediatric Population: Classification and Diagnostic Strategies. J Asthma Allergy. 2022 Sep 28;15:1383-1399. doi: 10.2147/JAA.S267005. eCollection 2022.
- Results publication: PubMed 29693290Kidon M, Blanca-Lopez N, Gomes E, Terreehorst I, Tanno L, Ponvert C, Chin CW, Caubet JC, Soyer O, Mori F, Blanca M, Atanaskovic-Markovic M. EAACI/ENDA Position Paper: Diagnosis and management of hypersensitivity reactions to non-steroidal anti-inflammatory drugs (NSAIDs) in children and adolescents. Pediatr Allergy Immunol. 2018 Aug;29(5):469-480. doi: 10.1111/pai.12915. Epub 2018 Jun 13.
- Individual participant dataSharing planned: Yes. Data will be available beginning 6 months after publication and will remain accessible for 5 years. The results will be available in clinicaltrials.gov with supporting information (Clinical Study Report (CSR)).
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 NSAID and Biomarkers, run by Fundació Sant Joan de Déu at 1 site in Spain.
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 2 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 24 Jun 2025. 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 Spain. 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?
Clinical characteristics of pediatric patients with NSAID hypersensitivity, based on historical data and development of a diagnostic protocol. (time frame: Retrospective arm: review of the medical records took about 4-6 months Prospective arm: from enrollment to DPT, 6-8 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07034066, which also lists 5 linked publications.
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 24 Jun 2025.