Study on the Effects of Mepolizumab for Achieving Clinical Remission in Patients with Severe Asthma

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Nucala on individuals with severe asthma. Severe asthma is a type of asthma that is difficult to control and often requires more intensive treatment. The medication being tested, Nucala, contains an active substance known as mepolizumab, which is administered as a solution for injection. Mepolizumab is a type of protein that helps reduce inflammation in the airways, potentially improving asthma symptoms.

The purpose of this study is to evaluate how well Nucala can help patients with severe asthma achieve what is known as clinical remission, which means a significant reduction or absence of asthma symptoms. Participants in the study will receive Nucala through subcutaneous injections, which means the medication is injected under the skin. The study will follow participants over a period of 24 months to observe the effects of the treatment. Some participants may receive a placebo, which is a substance with no active medication, to compare the results.

Throughout the study, researchers will monitor the participants’ asthma symptoms and overall health to determine the effectiveness of Nucala in achieving clinical remission. The study aims to provide valuable insights into the potential benefits of Nucala for individuals with severe asthma, helping to improve treatment options for this challenging condition. Participants will be closely observed to ensure their safety and well-being during the trial period.

1 joining the study

Upon joining the study, the participant must be an adult aged 18 years or over with a confirmed diagnosis of severe asthma.

The participant must have a physician’s decision to start treatment with Nucala and meet specific lung function criteria.

Written informed consent is required to participate in the study.

2 treatment initiation

The participant will begin treatment with Nucala, which is a 100 mg solution for injection.

The medication is administered through a subcutaneous injection, which means it is injected under the skin.

The treatment is provided using either a pre-filled syringe or a pre-filled pen.

3 treatment duration

The treatment with Nucala is expected to continue for a duration of 12 months.

During this period, the participant’s response to the treatment will be monitored to evaluate the achievement of clinical remission.

4 evaluation of outcomes

The primary goal is to assess the proportion of participants achieving clinical remission at 12 months.

Secondary outcomes include the reduction of asthma exacerbations and the ability to reduce oral corticosteroid use.

Changes in the participant’s quality of life will also be measured using a specific questionnaire.

5 completion of the study

The study is estimated to conclude by July 31, 2026.

Upon completion, the data collected will be analyzed to determine the effectiveness of Nucala in achieving clinical remission in severe asthma.

Who Can Join the Study?

  • Adults aged 18 years or older can participate.
  • The participant must have a confirmed diagnosis of asthma. This means a doctor has determined that the person has asthma.
  • The doctor must have decided to start treatment with NUCALA, which is a medication used for asthma.
  • The participant should have a predicted FEV1 of 60% or more. FEV1 stands for “Forced Expiratory Volume in one second,” which is a measure of how much air a person can forcefully exhale in one second. It helps to assess lung function.
  • The participant should have 4 or fewer exacerbations per year. An exacerbation is a worsening or flare-up of asthma symptoms.
  • The participant must provide written informed consent. This means they agree to participate in the study after being informed about what it involves.

Who Cannot Join the Study?

  • Patients with severe asthma cannot participate. Severe asthma is a type of asthma that is difficult to control and may require high doses of medication.
  • Patients who are not able to follow the treatment plan with NUCALA are excluded. NUCALA is a medication used to treat certain types of asthma.
  • Patients who are not in the age range specified for the study cannot participate. The study is for certain age groups only.
  • Patients who are part of a vulnerable population may not be eligible. Vulnerable populations include groups that may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Centre hospitalier universitaire de Liege Liege Belgium
Universitaetsklinikum Aachen AöR Aachen Germany
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Pneumo Studien Darmstadt GmbH Darmstadt Germany
IKF Pneumologie GmbH & Co. KG Frankfurt Germany
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana Treviso Italy
Centre Hospitalier De Cannes Simone Veil Cannes France
Hospital Arnau De Vilanova De Valencia Valencia Spain
Universita’ Campus Bio-medico Di Roma Rome Italy
IRCCS Ospedale Policlinico San Martino Genoa Italy
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
Centre Hospitalier Lyon Sud Pierre Benite France
Azienda Ospedaliera Universitaria Di Cagliari Monserrato Italy
Pzlyvksskqgprkmklh Weohyzecrsibxgqgr Gys Hohenstein-Ernstthal Germany
Lyndpkmyermg Baan Bonn Germany
Pvkhdnddtdfq Atompjahklul Pizibc Ddm Tgwhye Gfuut Bonn Germany
Pvhhoc Rakrxthuikk Hrjwit Suta Barcelona Spain
Unbandibsbpnjf Cbwbaqa Keyepchho Gdansk Poland
Huypheta Dd Ly Sqifa Cyom I Sxdm Plt Barcelona Spain
Svdvrqnhckvkme Dqq Kcsglw Frankfurt Germany
Hndetqrh Uigjzyughwdckj Syshbuhlpb &cjqvua Hwlkzwj du Hqpzbbseogd STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.05.2024
France France
Not recruiting
01.05.2024
Germany Germany
Not recruiting
01.05.2024
Italy Italy
Not recruiting
01.05.2024
Poland Poland
Not recruiting
01.05.2024
Spain Spain
Not recruiting
01.05.2024

Trial locations

Investigated drugs:

Mepolizumab is a medication used in this clinical trial to help people with severe asthma. It works by reducing inflammation in the airways, which can help improve breathing and decrease asthma attacks. The study aims to see how effective mepolizumab is in helping patients achieve clinical remission, meaning their asthma symptoms are significantly reduced or gone.

Severe Asthma – Severe asthma is a chronic lung condition characterized by frequent and intense symptoms such as wheezing, shortness of breath, chest tightness, and coughing. Unlike mild or moderate asthma, severe asthma does not respond well to standard treatments and can significantly impact daily life. The disease involves inflammation and narrowing of the airways, leading to difficulty in breathing. It often requires specialized management and can be associated with frequent asthma attacks or exacerbations. These exacerbations can lead to increased use of healthcare resources, such as emergency room visits or hospitalizations. The condition may also require the use of high-dose medications to control symptoms and prevent attacks.

Trial ID:
2023-509026-21-00
Protocol code:
219871
NCT ID:
NCT06041386
Trial Phase:
Therapeutic confirmatory (Phase III)

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