Study on Stopping Dupilumab in Patients with Severe Asthma Who Have Been on the Drug for Over 3 Years

1 1 1 1

What is this study about?

This clinical trial focuses on severe asthma, a condition where the airways in the lungs become inflamed and narrowed, making it difficult to breathe. The study examines the effects of stopping a medication called Dupixent (also known as dupilumab), which is used to treat severe asthma. Dupixent is given as a solution for injection under the skin using a pre-filled syringe.

The purpose of the study is to compare the outcomes of patients who stop taking Dupixent with those who continue using it. Participants in the study have been using Dupixent for at least three years and have their asthma well-controlled. The study will observe these patients over a period of 24 months to see if stopping the medication affects their asthma control.

Throughout the study, researchers will monitor the participants’ asthma symptoms and any changes in their condition. They will look at factors such as the number of asthma flare-ups, changes in asthma control scores, and whether patients need to restart Dupixent or switch to another treatment. The goal is to understand if stopping Dupixent is as effective as continuing it for patients with well-controlled severe asthma.

1 randomization

Participants are randomly assigned to one of two groups: the intervention group, which stops using dupilumab, or the control group, which continues using dupilumab.

The purpose is to compare the effects of stopping the medication with continuing it.

2 initial assessment

An initial assessment is conducted to establish a baseline for asthma control using the asthma control test (ACT) score.

The ACT score helps measure how well asthma is being managed.

3 medication administration

Participants in the control group continue receiving dupilumab as a subcutaneous injection.

The medication is administered as a 300 mg solution in a pre-filled syringe.

4 follow-up assessments

Follow-up assessments occur at 6, 12, and 24 months to monitor asthma control and any changes in the ACT score.

These assessments help determine if there is a loss of asthma control or any exacerbations.

5 monitoring for strategy failure

Participants are monitored for strategy failure, defined as having two or more asthma exacerbations per year or needing to resume dupilumab or switch to another medication.

This monitoring continues for 24 months following randomization.

6 final evaluation

A final evaluation is conducted at the end of the 24-month period to assess the overall effectiveness of stopping versus continuing dupilumab.

The evaluation includes a comparison of asthma control, exacerbations, and any adverse effects experienced by participants.

Who Can Join the Study?

  • Must be an adult, which means being 18 years old or older.
  • Must have been treated with dupilumab for at least 36 months. Dupilumab is a medication prescribed by a lung specialist, known as a pneumologist, for severe asthma.
  • Must have well-controlled asthma. This is determined by an ACT score of 18 or higher and having 0 or 1 asthma flare-up in the year before joining the study. An ACT score is a way to measure how well asthma is being managed.
  • Must be part of a social security scheme or have a similar type of health coverage.
  • Must provide free, informed, and written consent. This means agreeing to participate in the study after understanding all the details, and signing a consent form along with the study investigator.
  • Women who can have children must use effective contraception to prevent pregnancy during the study.

Who Cannot Join the Study?

  • Patients with severe asthma cannot participate. Severe asthma is a type of asthma that is very difficult to control, even with high doses of medication.
  • Patients who have not been receiving dupilumab for at least 36 months cannot participate. Dupilumab is a medication used to treat certain types of asthma.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups of people who may be at a higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Lyon Sud Pierre Benite France
Centre Hospitalier Intercommunal Creteil Creteil France
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Hospital Foch Suresnes France
Centre Hospitalier De Cannes Simone Veil Cannes France
Centre Hospitalier Le Mans Le Mans France
Centre Hospitalier De La Cote Basque Bayonne France
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital NOVO Pontoise France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Centre d’Investigation Clinique – UF 1042 – CHRU Strasbourg – Nouvel Hôpital Civil STRASBOURG, Alsace France
Centre Hospitalier Universitaire de la Réunion – Site Sud Saint Pierre France
Clinique De L’Archette olivet France
Victor Provo Hospital Roubaix France
Centre Hospitalier Tarbes-Lourdes Tarbes France
Hnbfphf Hxyg Lmfrzcc &phghlq Ge Sry &sdeekx Csf dt Bnqffbky Pessac France
Cfv Doofc Bmhcolrek Hmiayha Fjfklqxq Mcsovvzac Dijon France
Com dpokjihbkyswmw Epagny Metz Tessy France
Bbaqncge Utworxfgwa Htqsaitj Cqprhg Besançon France
Crdjag Hfyjsbmybtg Rmyjhwer Uspabykzlukbo De Txnke Tours France
Chwial Hybmtwocypw Rhkpukaa Degacsugvayrax Angers France
Cdb Cnnvl Rwyaqvdpgle Lyon France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
02.12.2024

Trial locations

Investigated drugs:

Dupilumab is a medication used in the treatment of severe asthma. It works by blocking certain proteins in the body that can cause inflammation, helping to control asthma symptoms. In this clinical trial, the role of dupilumab is to evaluate whether stopping the medication is as effective as continuing it in patients who have been using it for at least 36 months.

Investigated diseases:

Severe Asthma – Severe asthma is a chronic respiratory condition characterized by frequent and intense symptoms such as wheezing, shortness of breath, chest tightness, and coughing. It occurs when the airways in the lungs become inflamed and narrowed, making it difficult to breathe. This form of asthma is more persistent and less responsive to standard treatments compared to milder forms. Patients with severe asthma may experience frequent exacerbations, which are episodes where symptoms worsen significantly. These exacerbations can be triggered by various factors, including allergens, respiratory infections, and environmental irritants. Managing severe asthma often requires a comprehensive approach to control symptoms and prevent exacerbations.

Trial ID:
2024-516789-13-00
Protocol code:
RC31/24-0325
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Testing WIN378 Safety and Effects in Adults with Moderate or Severe Asthma

    Recruiting

    Investigated diseases:
    Bulgaria France Germany Spain Sweden
  • A study to evaluate the effects of KT-621 in adults with moderate to severe eosinophilic asthma

    Recruiting

    Austria Belgium Germany Italy Poland Romania +2