AERD - Aspirin Exacerbated Respiratory DiseasePhase 4NCT04442256
Effect of Dupilumab on Aspirin Intolerance
A Phase 4 study testing Dupilumab in people with AERD - Aspirin Exacerbated Respiratory Disease, run by Medical University of Vienna at 1 site in Austria.
Trial summary
To test the efficacy of dupilumab in patients with AERD regarding the intolerance to salicylic acid after 6 months. This will be evaluated by oral drug provocation testing with low dose salicylic acid after 6 months of dupilumab treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- AERD - Aspirin Exacerbated Respiratory Disease
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jun 2020to 31 Dec 2022
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dupilumab treatment group:
- Signed and dated informed consent has been obtained
- Age 18 - 70 years
- Male or female
- Diagnosed with AERD (nasal polyps, allergic asthma, aspirin intolerance)
- Chronic rhinosinusitis with nasal polyps (CRSwNP) (according to the European Position Paper on Rhinosinusitis and Nasal Polyps Guidelines)8
- Documented aspirin intolerance
- Asthma bronchial diagnosed by a respiratory physician (based on Global -Initiative for Asthma guidelines)9
Who cannot join
- Pregnancy
- 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
Trial locations and contacts
1 site in 1 country.
Tamara Quint, M.D contact
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Christine Bangert, M.D
Tamara Quint, M.D
About this study
Official title: Effect of Dupilumab on ASS Intolerance and Its Mechanisms in Patients With Aspirin-exacerbated Respiratory Disease (AERD)
To test the efficacy of dupilumab in patients with AERD regarding the intolerance to salicylic acid after 6 months. This will be evaluated by oral drug provocation testing with low dose salicylic acid after 6 months of dupilumab treatment.
Hypothesis:
After 6 months of therapy, patients will tolerate aspirin dose levels as tested with different dosages (125mg, 250mg and 500 mg).
Read the detailed description
30 patients suffering from AERD will be included in this single-center, prospective, explorative study for treatment with dupilumab. Before study initiation, informed consent will be obtained from all subjects. All patients with AERD can be included according to inclusion- and exclusion criteria.
AERD patients who had already obtained a monoclonal antibody for the treatment of asthma or polyps will also be included if at least a wash out period of 5 half -lives or 3 months has passed. The first visit will be performed at screening (day 0, V1/before dupilumab therapy). Clinically significant abnormal laboratory values will be ruled out prior to the first dose.
All patients will be administered subcutaneous doses of dupilumab in a biweekly fashion.
For several reasons comparison with placebo will not be performed:
- All patients included are in urgent need for an effective treatment.
- The only currently available alternative treatment option is a functional endoscopic sinus surgery (FESS). Usually there is a high recurrence rate after surgery.
- All included patients have a long medical history concerning AERD. The rate of a spontaneous improvement or resolution in this patient population is negligible.
Spirometry (peak-flow and FEV1) and an asthma control test will be performed prior to dupilumab therapy, after 1, 3 and 6 months. In addition, the sinonasal outcome test-22 and the total nasal endoscopic polyps score as well as nasal congestion score, disease severity (by visual analogue scale=VAS), total symptom score (TSS) will be performed at baseline, after 1,3 and 6 months. To further evaluate the polyp size, a nasal CT will be performed at screening visit. To evaluate the sense of smell we will perform UPSIT testing before and after 6 months dupilumab.
All patients will have routine laboratory testing (blood chemistry, hematology) before and after 6 months of therapy. Adverse events will be recorded at each visit. Biological activity will be evaluated based on peripheral blood eosinophil counts, serum total Immunoglobulin E (IgE) levels and measurement of eosinophilic cationic protein in patients' sera at baseline and after 6 months.
To assess local changes in the nose caused by dupilumab treatment, nasal secretions, nasal mucosa samples (nasal curette), nasal microbiome as well as nasal biopsies will be collected.
After the end of study, treatment will be continued in all patients with significant improvement in asthmatic symptoms, nasal symptoms as well as a reduction of polyps.
For patients who did not experience clinical improvement, dupilumab treatment will be discontinued after 6 months.
- Being tested
- Dupilumab
- Keywords
- AERD, Asthma, Morbus Widal, chronic rhinosinusitis with nasal polyps, dupilumab
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
All patients will be administered subcutaneous doses of dupilumab in a biweekly fashion.
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | Other | All patients will be administered subcutaneous doses of dupilumab in a monthly fashion. Observation period will be 30 minutes after injection Receives: Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximally tolerated aspirin dose level (stages 125mg, 250mg and 500mg)
Changes in the maximal ASS dose level tolerations (no toleration, 125mg, 250mg and 500mg) at baseline and after 6 months.
Measured: 6 months
Secondary outcomes (5)
Change of nasal polyps (TPS)
A secondary endpoint is the change of polyps after 6 months of treatment with dupilumab, which will be evaluated by an ENT specialist. The polyps will be evaluated on each side by means of nasal endoscopy and graded based on polyp size, resulting in scores of 0 to 4 (TPSs).
Measured: 6 months
Change of allergic asthma (Spirometry)
Changes in spirometry (FEV1%)
Measured: 6 months
Percentage of T and B cell subsets in nasal polyp tissues of patients treated with dupilumab as assessed with confocal microscopy
Biopisies of nasal polyps will be taken at baseline and after 6 months of treatment with Dupilumab. RNA will be isolated from part of the biopsy and subjected to bulk RNA sequencing. Genes up or downregulated upon treatment will be calculated by bioinformaticians. Biopsies will also be assessed by confocal microscopy upon staining for surface specific markers identifiying various T (T mem, reg T cells) and B (Plasma cell, memory cells) as well as other immune cell subpopulations.
Measured: 6 months
Change of allergic asthma (Asthma control test)
Change from baseline in allergic asthma on the asthma control test at 6 months.
Measured: 6 months
Change of nasal polyps (SNOT-22)
Changes in sinus nasal outcome test-22 (SNOT 22) between baseline and 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Jun 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
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 AERD - Aspirin Exacerbated Respiratory DiseaseStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Only one group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamara Quint, Medical University of Vienna
- Investigators
- Christine Bangert, M.D., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442256
- Sponsor's protocol ID
- 2019-004889-18
- Other IDs
- 2019
- Status last verified
- Apr 2022
- First submitted
- 3 Jun 2020
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Eckl-Dorna J, Morgenstern C, Poglitsch K, Arnoldner T, Gangl K, Bartosik TJ, Campion NJ, Tu A, Stanek V, Schneider S, Bangert C. Dupilumab Dampens Mucosal Type 2 Response During Acetylsalicylic Acid Challenge in N-ERD Patients. Clin Exp Allergy. 2026 Mar;56(3):227-242. doi: 10.1111/cea.70184. Epub 2025 Nov 27.
PubMed 41309110
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dupilumab on ASS Intolerance and Its Mechanisms in Patients With Aspirin-exacerbated Respiratory Disease (AERD)
- ClinicalTrials.gov ID
- NCT04442256
- Acronym / sponsor ID
- 2019-004889-18
- Keywords
- AERD, Asthma, Morbus Widal, chronic rhinosinusitis with nasal polyps, dupilumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 Jun 2020 (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.
To test the efficacy of dupilumab in patients with AERD regarding the intolerance to salicylic acid after 6 months. This will be evaluated by oral drug provocation testing with low dose salicylic acid after 6 months of dupilumab treatment.
Hypothesis:
After 6 months of therapy, patients will tolerate aspirin dose levels as tested with different dosages (125mg, 250mg and 500 mg).
Detailed description
30 patients suffering from AERD will be included in this single-center, prospective, explorative study for treatment with dupilumab. Before study initiation, informed consent will be obtained from all subjects. All patients with AERD can be included according to inclusion- and exclusion criteria.
AERD patients who had already obtained a monoclonal antibody for the treatment of asthma or polyps will also be included if at least a wash out period of 5 half -lives or 3 months has passed. The first visit will be performed at screening (day 0, V1/before dupilumab therapy). Clinically significant abnormal laboratory values will be ruled out prior to the first dose.
All patients will be administered subcutaneous doses of dupilumab in a biweekly fashion.
For several reasons comparison with placebo will not be performed:
- All patients included are in urgent need for an effective treatment.
- The only currently available alternative treatment option is a functional endoscopic sinus surgery (FESS). Usually there is a high recurrence rate after surgery.
- All included patients have a long medical history concerning AERD. The rate of a spontaneous improvement or resolution in this patient population is negligible.
Spirometry (peak-flow and FEV1) and an asthma control test will be performed prior to dupilumab therapy, after 1, 3 and 6 months. In addition, the sinonasal outcome test-22 and the total nasal endoscopic polyps score as well as nasal congestion score, disease severity (by visual analogue scale=VAS), total symptom score (TSS) will be performed at baseline, after 1,3 and 6 months. To further evaluate the polyp size, a nasal CT will be performed at screening visit. To evaluate the sense of smell we will perform UPSIT testing before and after 6 months dupilumab.
All patients will have routine laboratory testing (blood chemistry, hematology) before and after 6 months of therapy. Adverse events will be recorded at each visit. Biological activity will be evaluated based on peripheral blood eosinophil counts, serum total Immunoglobulin E (IgE) levels and measurement of eosinophilic cationic protein in patients' sera at baseline and after 6 months.
To assess local changes in the nose caused by dupilumab treatment, nasal secretions, nasal mucosa samples (nasal curette), nasal microbiome as well as nasal biopsies will be collected.
After the end of study, treatment will be continued in all patients with significant improvement in asthmatic symptoms, nasal symptoms as well as a reduction of polyps.
For patients who did not experience clinical improvement, dupilumab treatment will be discontinued after 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Only one group
| Arm | Type | Receives |
|---|---|---|
| Dupilumab | Other | Drug: DupilumabAll patients will be administered subcutaneous doses of dupilumab in a monthly fashion. Observation period will be 30 minutes after injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed and dated informed consent has been obtained
- Age 18 - 70 years
- Male or female
- Diagnosed with AERD (nasal polyps, allergic asthma, aspirin intolerance)
- Chronic rhinosinusitis with nasal polyps (CRSwNP) (according to the European Position Paper on Rhinosinusitis and Nasal Polyps Guidelines)8
Key exclusion criteria (5 listed)
- Pregnancy
- 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
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 |
|---|---|---|
| DupilumabAll patients will be administered subcutaneous doses of dupilumab in a biweekly fashion. | Drug | Dupilumab |
Primary outcome
Maximally tolerated aspirin dose level (stages 125mg, 250mg and 500mg)
Time frame: 6 months
Changes in the maximal ASS dose level tolerations (no toleration, 125mg, 250mg and 500mg) at baseline and after 6 months.
5 secondary outcomes
Change of nasal polyps (TPS)
Time frame: 6 months
Change of allergic asthma (Spirometry)
Time frame: 6 months
Percentage of T and B cell subsets in nasal polyp tissues of patients treated with dupilumab as assessed with confocal microscopy
Time frame: 6 months
Change of allergic asthma (Asthma control test)
Time frame: 6 months
Change of nasal polyps (SNOT-22)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Derived from this study: PubMed 41309110Eckl-Dorna J, Morgenstern C, Poglitsch K, Arnoldner T, Gangl K, Bartosik TJ, Campion NJ, Tu A, Stanek V, Schneider S, Bangert C. Dupilumab Dampens Mucosal Type 2 Response During Acetylsalicylic Acid Challenge in N-ERD Patients. Clin Exp Allergy. 2026 Mar;56(3):227-242. doi: 10.1111/cea.70184. Epub 2025 Nov 27.
- Individual participant dataSharing planned: Yes
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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.
Tamara Quint, M.D contact
Christine Bangert, M.D. principal investigator
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?
A Phase 4 study testing Dupilumab in people with AERD - Aspirin Exacerbated Respiratory Disease, 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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Apr 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine Bangert, M.D (004314040025310, christine.bangert@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximally tolerated aspirin dose level (stages 125mg, 250mg and 500mg) (time frame: 6 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 NCT04442256, 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 6 Apr 2022.