NCT04442256

Brief 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. Hypothesis: After 6 months of therapy, patients will tolerate aspirin dose levels as tested with different dosages (125mg, 250mg and 500 mg).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

2.6 years

First QC Date

June 3, 2020

Last Update Submit

April 5, 2022

Conditions

AERD - Aspirin Exacerbated Respiratory Disease

Keywords

AERDAsthmaMorbus Widalchronic rhinosinusitis with nasal polypsdupilumab

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (5)

  • Change of nasal polyps (TPS)

    6 months

  • Change of allergic asthma (Spirometry)

    6 months

  • Percentage of T and B cell subsets in nasal polyp tissues of patients treated with dupilumab as assessed with confocal microscopy

    6 months

  • Change of allergic asthma (Asthma control test)

    6 months

  • Change of nasal polyps (SNOT-22)

    6 months

Study Arms (1)

Dupilumab

OTHER

All patients will be administered subcutaneous doses of dupilumab in a monthly fashion. Observation period will be 30 minutes after injection

Drug: Dupilumab

Interventions

DupilumabDRUG

All patients will be administered subcutaneous doses of dupilumab in a biweekly fashion.

Dupilumab

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Related Publications (1)

  • 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. 2025 Nov 27. doi: 10.1111/cea.70184. Online ahead of print.

    PMID: 41309110DERIVED

MeSH Terms

Conditions

Asthma

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Christine Bangert, M.D.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Bangert, M.D

CONTACT

004314040025310christine.bangert@meduniwien.ac.at

Tamara Quint, M.D

CONTACT

tamara.quint@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Only one group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 22, 2020

Study Start

June 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

April 6, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

Locations

AU(1)