NSAID-Induced AsthmaNCT07049978
Long-term Effect of Dupilumab in N-ERD
An observational study of NSAID-Induced Asthma and NSAIDs Hypersensitivity, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This prospective observational study investigates the long-term effects of Dupilumab in patients with NSAID-exacerbated respiratory disease (N-ERD). The study assesses changes in ASA tolerance, clinical parameters, inflammatory biomarkers, quality of life, and nasal microbiome during ongoing treatment with Dupilumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSAID-Induced Asthma, NSAIDs Hypersensitivity, Chronic Rhinosinusitis (CRS)
- What is being tested?
- Observational follow-up of standard Dupilumab treatment
- How many people
- 15 participants
- Where
- 1 siteAustria
- Study dates
- 1 Sep 2025to 7 May 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with NSAID-exacerbated respiratory disease (NERD), previously included in a Dupilumab follow-up study, now being evaluated after ≥3 years of treatment.
Who may be able to join
- Participated previously in our preliminary study (EK 1044/2020) and continued Dupilumab treatment since then. Long-term use of Dupilumab since the preliminary study will be assessed based on patient self-report, as there is currently no clinical test or laboratory parameter available to objectively verify treatment duration.
- Signed and dated informed consent has been obtained
- Current therapy with Dupilumab
Who cannot join
- Pregnancy (as determined by urine ß-HCG test)
- Clinically significant abnormal laboratory values and active infection (Tbc, HIV, hepatitis A/B/C)
- History of malignancy or immunodeficiency
- Chronic obstructive lung disorders (COPD), other obstructive lung disorders (bronchiolitis)
- Need for systemic corticosteroid therapy 1 month prior to screening visit
- Eosinophilic pneumonia and Churg-Strauss Syndrome
- Previous anaphylaxis and contraindications against ASA as outlined in the official prescribing information.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Effect of Dupilumab on Acetylsalicylic Acid (ASA) Intolerance and Its Mechanisms in Patients With Non-steroidal Anti-inflammatory Drug-exacerbated Respiratory Disease (N-ERD)
This prospective observational study investigates the long-term effects of Dupilumab in patients with NSAID-exacerbated respiratory disease (N-ERD). The study assesses changes in ASA tolerance, clinical parameters, inflammatory biomarkers, quality of life, and nasal microbiome during ongoing treatment with Dupilumab. All participants are receiving Dupilumab as part of standard clinical care.
- Conditions
- NSAID-Induced Asthma, NSAIDs Hypersensitivity, Chronic Rhinosinusitis (CRS), Asthma Bronchiale, Nasal Polyposis
- Being tested
- Observational follow-up of standard Dupilumab treatment
- Medical subject headings
- Asthma, Aspirin-Induced, Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational follow-up of standard Dupilumab treatmentOther
Patients undergoing Dupilumab treatment for N-ERD will be observed after three to four years of treatment to assess long term changes in ASA tolerance, clinical parameters, inflammatory biomarkers, quality of life, and nasal microbiome during ongoing treatment with Dupilumab. All participants are receiving Dupilumab as part of standard clinical care.
| Study group | Role | What they receive |
|---|---|---|
| N-ERD patients with long-term Dupilumab treatment | Patients diagnosed with N-ERD undergoing Dupilumab treatment between 3 and 4 years Receives: Other: Observational follow-up of standard Dupilumab treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ASA tolerance
Change in aspirin tolerance assessed via oral provocation test with standardized protocol
Measured: Historical (pre-treatment and 6 months) vs. current data (after ≥3 years of treatment)
Secondary outcomes (5)
Change in Sino-Nasal Outcome Test 22 (SNOT-22) score compared to early response
Sinonasal symptoms assessed with SNOT-22 questionnaire at long-term follow-up, higher score means higher limitation by disease.
Measured: Historical (pre-treatment and 6 months) vs. current data (after ≥3 years of treatment)
Change in European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L) score compared to early response
General quality of life at long-term follow-up, higher score means good QoL.
Measured: Historical baseline and 6-month vs. current score (≥3 years post-treatment)
Change in Asthma Control Questionnaire (ACQ-5) score
Asthma control evaluated via ACQ-5, high score means high disease burden.
Measured: Historical baseline and 6-month vs. current score (≥3 years post-treatment)
Change in peripheral eosinophil count
Long-term effect of Dupilumab on peripheral eosinophils
Measured: Historical baseline and 6-month vs. current score (≥3 years post-treatment)
Nasal microbiome composition at long-term follow-up
Microbial composition from nasal swabs assessed via sequencing
Measured: Historical baseline and 6-month vs. current score (≥3 years post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Sep 2025
- Primary completion7 May 2026
- Study completion7 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NSAID-Induced AsthmaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sven Schneider, MD, Medical University of Vienna
- Investigators
- Sven Schneider Dr. med. univ., MD, Principal investigator, Senior doctor and Department of Otorhinolaryngology at Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049978
- Sponsor's protocol ID
- DUPI-NERD-02
- Status last verified
- Jul 2025
- First submitted
- 25 Jun 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schneider S, Poglitsch K, Morgenstern C, Quint T, Gangl K, Sinz C, Bartosik T, Campion NJ, Liu DT, Landegger LD, Tu A, Stanek V, Rocha-Hasler M, Bangert C, Eckl-Dorna J. Dupilumab increases aspirin tolerance in NSAID-exacerbated respiratory disease. Eur Respir J. 2023 Mar 16;61(3):2201335. doi: 10.1183/13993003.01335-2022. Print 2023 Mar.
PubMed 36549708
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effect of Dupilumab on Acetylsalicylic Acid (ASA) Intolerance and Its Mechanisms in Patients With Non-steroidal Anti-inflammatory Drug-exacerbated Respiratory Disease (N-ERD)
- ClinicalTrials.gov ID
- NCT07049978
- Acronym / sponsor ID
- DUPI-NERD-02
- Conditions
- NSAID-Induced Asthma, NSAIDs Hypersensitivity, Chronic Rhinosinusitis (CRS), Asthma Bronchiale, Nasal Polyposis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 7 May 2026 (actual)
- Study completion
- 7 May 2026 (actual)
- First posted
- 3 Jul 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.
This prospective observational study investigates the long-term effects of Dupilumab in patients with NSAID-exacerbated respiratory disease (N-ERD). The study assesses changes in ASA tolerance, clinical parameters, inflammatory biomarkers, quality of life, and nasal microbiome during ongoing treatment with Dupilumab. All participants are receiving Dupilumab as part of standard clinical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| N-ERD patients with long-term Dupilumab treatment | – | Other: Observational follow-up of standard Dupilumab treatmentPatients diagnosed with N-ERD undergoing Dupilumab treatment between 3 and 4 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with NSAID-exacerbated respiratory disease (NERD), previously included in a Dupilumab follow-up study, now being evaluated after ≥3 years of treatment.
Key inclusion criteria (3 listed)
- Participated previously in our preliminary study (EK 1044/2020) and continued Dupilumab treatment since then. Long-term use of Dupilumab since the preliminary study will be assessed based on patient self-report, as there is currently no clinical test or laboratory parameter available to objectively verify treatment duration.
- Signed and dated informed consent has been obtained
- Current therapy with Dupilumab
Key exclusion criteria (7 listed)
- Pregnancy (as determined by urine ß-HCG test)
- Clinically significant abnormal laboratory values and active infection (Tbc, HIV, hepatitis A/B/C)
- History of malignancy or immunodeficiency
- Chronic obstructive lung disorders (COPD), other obstructive lung disorders (bronchiolitis)
- Need for systemic corticosteroid therapy 1 month prior to screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational follow-up of standard Dupilumab treatmentPatients undergoing Dupilumab treatment for N-ERD will be observed after three to four years of treatment to assess long term changes in ASA tolerance, clinical parameters, inflammatory biomarkers, quality of life, and nasal microbiome during ongoing treatment with Dupilumab. All participants are receiving Dupilumab as part of standard clinical care. | Other | N-ERD patients with long-term Dupilumab treatment |
Primary outcome
Change in ASA tolerance
Time frame: Historical (pre-treatment and 6 months) vs. current data (after ≥3 years of treatment)
Change in aspirin tolerance assessed via oral provocation test with standardized protocol
5 secondary outcomes
Change in Sino-Nasal Outcome Test 22 (SNOT-22) score compared to early response
Time frame: Historical (pre-treatment and 6 months) vs. current data (after ≥3 years of treatment)
Change in European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L) score compared to early response
Time frame: Historical baseline and 6-month vs. current score (≥3 years post-treatment)
Change in Asthma Control Questionnaire (ACQ-5) score
Time frame: Historical baseline and 6-month vs. current score (≥3 years post-treatment)
Change in peripheral eosinophil count
Time frame: Historical baseline and 6-month vs. current score (≥3 years post-treatment)
Nasal microbiome composition at long-term follow-up
Time frame: Historical baseline and 6-month vs. current score (≥3 years post-treatment)
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 7 Oct 2026.
- Results publication: PubMed 36549708Schneider S, Poglitsch K, Morgenstern C, Quint T, Gangl K, Sinz C, Bartosik T, Campion NJ, Liu DT, Landegger LD, Tu A, Stanek V, Rocha-Hasler M, Bangert C, Eckl-Dorna J. Dupilumab increases aspirin tolerance in NSAID-exacerbated respiratory disease. Eur Respir J. 2023 Mar 16;61(3):2201335. doi: 10.1183/13993003.01335-2022. Print 2023 Mar.
- Individual participant dataSharing planned: No
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.
Sven Schneider Dr. med. univ., MD principal investigator
Senior doctor and Department of Otorhinolaryngology at Medical University of Vienna
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-Induced Asthma and NSAIDs Hypersensitivity, run by Medical University of Vienna at 1 site in Austria.
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 3 inclusion and 7 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 7 Oct 2026. 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 Austria. 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?
Change in ASA tolerance (time frame: Historical (pre-treatment and 6 months) vs. current data (after ≥3 years of treatment)). 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 NCT07049978, which also lists 1 linked publication.
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 7 Oct 2026.