Study on the Long-term Effects of Dupilumab for Patients with Aspirin-Exacerbated Respiratory Disease (AERD)

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Dupilumab on a condition known as non-steroidal anti-inflammatory drug-exacerbated respiratory disease (N-ERD). N-ERD is a type of respiratory disease that worsens when patients take certain pain relievers, like aspirin. The medication being tested, Dupilumab, is given as a solution for injection using a pre-filled syringe.

The purpose of this study is to understand how Dupilumab affects patients with N-ERD, particularly in terms of their tolerance to aspirin. The study aims to see if patients can tolerate higher doses of aspirin after being treated with Dupilumab for a long period. Participants will receive Dupilumab through subcutaneous injection, which means the medication is injected under the skin. The study will observe changes in aspirin tolerance before treatment, during treatment, and six months after starting the treatment.

Throughout the study, various health indicators will be monitored, such as levels of certain proteins and cells in the blood, as well as the presence of specific substances in nasal secretions and urine. The study will also assess changes in the sense of smell and the composition of bacteria in the nose. These observations will help researchers understand the broader effects of Dupilumab on the body and its potential benefits for patients with N-ERD.

1 joining the study

Upon joining the study, ensure that the informed consent form is signed and dated. This confirms understanding and agreement to participate in the study.

2 initial assessment

An initial assessment will be conducted to evaluate current health status and confirm eligibility. This includes reviewing participation in a previous study and current therapy with Dupilumab.

3 treatment with Dupilumab

Continue current therapy with Dupilumab, which is administered as a subcutaneous injection. The dosage is 300 mg, provided in a pre-filled syringe. The frequency and duration of administration will be as per the existing treatment plan.

4 monitoring and assessments

Regular monitoring and assessments will be conducted to evaluate the effects of Dupilumab on salicylic acid tolerance. This includes testing tolerated aspirin dose levels at different dosages (62.5 mg, 125 mg, 250 mg, and 500 mg) compared to levels before and 6 months into treatment.

Additional assessments may include blood tests, skin prick tests, and evaluations of olfactory performance, prostaglandin levels in urine, cytokine patterns in nasal secretions, and nasal microbiome composition.

5 completion of the study

The study is estimated to end by March 31, 2026. Upon completion, a final assessment will be conducted to evaluate the long-term effects of Dupilumab on salicylic acid tolerance and other health parameters.

Who Can Join the Study?

The patient must have previously participated in a study called EK 1044/2020.
The patient must have signed and dated an informed consent form. This means they have agreed to participate in the study after being informed about it.
The patient must currently be receiving treatment with Dupilumab, which is a medication used for certain conditions.
The study is open to both male and female patients.
The study is not specifically for vulnerable populations, meaning it is not designed for groups that might need special protection or care.

Who Cannot Join the Study?

Patients with a condition called non-steroidal anti-inflammatory drug-exacerbated respiratory disease (N-ERD) cannot participate. This is a condition where certain pain relievers make breathing problems worse.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.

Where you can join this trial?

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Verified Sites

Site Name	City	Country	Status
Medical University Of Vienna	Vienna	Austria

Other Sites

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Trial status

Country	Status	Recruitment Start
Austria	Not yet recruiting	01.04.2025

Trial locations

Investigated drugs:

Dupilumab

Dupilumab is a medication used in this clinical trial to help people who have a condition called non-steroidal anti-inflammatory drug-exacerbated respiratory disease (N-ERD). This condition makes it hard for some people to tolerate certain pain relievers like aspirin. Dupilumab works by blocking certain proteins in the body that can cause inflammation and breathing problems. The goal of using Dupilumab in this study is to see if it can help patients become more tolerant to aspirin over time, making it easier for them to manage their condition without having to avoid these common medications.

Non-steroidal anti-inflammatory drug-exacerbated respiratory disease (N-ERD) – This condition is characterized by a combination of asthma, chronic rhinosinusitis with nasal polyps, and sensitivity to aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs). When individuals with N-ERD take these medications, they may experience worsening respiratory symptoms, such as nasal congestion, runny nose, and asthma attacks. The disease progresses with persistent inflammation in the airways and sinuses, leading to chronic symptoms. Over time, patients may develop nasal polyps, which are non-cancerous growths in the nasal passages that can cause further breathing difficulties. The condition is often associated with elevated levels of certain immune cells and inflammatory markers in the body. Management of symptoms typically involves avoiding NSAIDs and addressing the underlying inflammation.

Trial ID:

2024-520082-31-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Long-term Effects of Dupilumab for Patients with Aspirin-Exacerbated Respiratory Disease (AERD)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?