Aspirin-exacerbated Respiratory Disease Clinical Trial
Official title:
Dupilumab as add-on Therapy for Aspirin-exacerbated Respiratory Disease (AERD)
Subjects with physician-diagnosed aspirin-exacerbated respiratory disease (AERD) who remain unacceptably symptomatic with a SNOT 22 score > 18 despite routine medical therapy will be enrolled in this single center, single-blinded study assessing the efficacy of dupilumab in AERD.
This is a single blind, placebo controlled trial to be conducted in adult patients with AERD
to determine the efficacy and safety of dupilumab in treating symptoms of chronic
rhinosinusitis.
All subjects will be treated with the FDA-approved and the commercially available dose for
adult atopic dermatitis of 300 mg every 2 weeks administered subcutaneously, based on the
observed efficacy and safety of this dose. In addition to atopic dermatitis, this dose has
also been shown to be efficacious in adult asthma.15 Patients will not be treated with a
loading dose since other studies of dupilumab in asthma and chronic rhinosinusitis with nasal
polyposis have not used a loading dose.
There will be a one month screening period to determine the patient's eligibility and
establish symptom control and baseline parameters.
Patients will continue their background medications for chronic rhinosinusitis with nasal
polyposis and asthma. These medications may include nasal corticosteroids, nasal
antihistamines, systemic antihistamines, leukotriene receptor antagonists, 5 lipo-oxygenase
inhibitors, inhaled corticosteroids, long-acting beta agonists, and long acting muscarinic
antagonists. These controller medications will not be dispensed or supplied by the sponsor.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT03627481 -
Sleep Quality After Nasosinusal Surgery in AERD Patients
|
N/A | |
| Recruiting |
NCT05672030 -
Role of IL-5R Signaling in Non-eosinophil Upper Airway Cells in CRSwNP
|
||
| Completed |
NCT03849625 -
Characteristics of Patients Diagnosed With NSAID Sensitivity in Thailand
|
||
| Recruiting |
NCT05031455 -
Mechanisms of Dupilumab in AERD
|
Phase 2 | |
| Active, not recruiting |
NCT03973749 -
Effects of a High or Low Salycilate Diet on Urinary LTE4 and Clinical Features in AERD
|
N/A | |
| Recruiting |
NCT04147013 -
Effect of Celecoxib on Postoperative Analgesia and Disease Severity in AERD Patients With CRS
|
Phase 4 | |
| Completed |
NCT01631773 -
A Comparison of microRNA Samples in Patients With Nasal Polyps and Aspirin Exacerbated Respiratory Disease and Those With Nasal Polyps Only
|
N/A | |
| Recruiting |
NCT05575037 -
Mechanisms of Benefit of IL4RA Inhibition in Aspirin-Exacerbated Respiratory Disease
|
Phase 2 | |
| Completed |
NCT03326063 -
Therapeutic Control of Aspirin-Exacerbated Respiratory Disease With Ifetroban
|
Phase 2 |