Use of Nucala in Severe Asthma (UNISA)

June 27, 2022 updated by: Medical Centre Leeuwarden

Evaluation of Real World Use of Nucala in Severe Asthma Patients From the Severe Heterogenous Asthma Research Patient-centred Collaboration (SHARP)

The Severe Heterogeneous Asthma Research collaboration, Patient-centred (SHARP) is set up to harmonise severe asthma management across Europe and unravel underlying heterogeneity in a patient-centred way. Using data from national registries included in the SHARP network, this study aims to evaluate real-world use of Nucala, describe characteristics of patients prescribed with Nucala and evaluate the effectiveness of Nucala in clinically relevant endpoints.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The global prevalence of asthma is approximately 358 million people, of which an estimated 30 million patients live in Europe. Severe asthma is defined as asthma requiring treatment according to GINA steps 4-5 and is estimated to occur in 5-10% of the total asthma population (Chung 2014). Asthma and severe asthma are heterogeneous, and while there are a range of classifications, one such schema classified asthma as: (1) eosinophilic, (2) neutrophilic, (3) mixed, or (4) paucigranulocytic.

NUCALA (mepolizumab) is an IL-5 antagonist monoclonal antibody that was approved by the European commission in 2015 for add-on maintenance treatment of adult patients with severe refractory eosinophilic asthma. The license was expanded to paediatric patients (6-17 years old) in August 2018. Clinical efficacy was evaluated in multiple randomized, double-blind clinical trials. In the DREAM trial (NCT01000506), the rate of clinically significant exacerbations was 2.40 per patient per year among patients receiving placebo versus 1.24 in the 75 mg IV mepolizumab group, a 48% (95% CI 31-61%) reduction. In the MENSA trial (NCT01691521), the rate of clinically significant exacerbations was 1.74 per patient per year among patients receiving placebo versus 0.83 in the sub-cutaneous 100 mg mepolizumab group, a 53% (95% CI 36-65%) reduction. Furthermore, in the SIRIUS trial (NCT01691508), the median daily prednisone dose at weeks 20-24 was 10.0 mg among patients receiving placebo versus 3.1 mg for patients receiving 100 mg of mepolizumab and mepolizumab provided a 2.39 (95% CI 1.25-4.56) times greater odds for a reduction in oral glucocorticoid dose from baseline in the mepolizumab group compared with placebo. Additionally, the MUSCA trial (NCT02281318) found that mepolizumab significantly improved health-related quality of life in patients with severe eosinophilic asthma.

The high internal validity of the randomized clinical trials has allowed the treatment efficacy of Nucala to be reliably determined in patients with severe eosinophilic asthma. However, the strict inclusion and exclusion criteria which are necessary in clinical trials produce data from a selected, homogeneous population which may not be representative of the wider population who may receive treatments in routine practice.

Real world evaluation of mepolizumab use will help in understanding characteristics of patients from different European countries receiving these therapies, treatment patterns, and effectiveness on clinical endpoints as limited information exists in real world settings in Europe following the availability of mepolizumab to patients.

The Severe Heterogeneous Asthma Research collaboration, Patient-centred (SHARP) is set up to harmonise severe asthma management across Europe and unravel underlying heterogeneity in a patient-centred way. Using data from national registries included in the SHARP network, this study aims to evaluate real-world use of Nucala, describe characteristics of patients prescribed with Nucala and evaluate the effectiveness of Nucala in clinically relevant endpoints.

Study Type

Observational

Enrollment (Actual)

2100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Friesland
      • Leeuwarden, Friesland, Netherlands, 8934 AD
        • Medical Centre Leeuwarden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population will be selected from all patients who meet the criteria for inclusion in individual registries severe asthma registries. Within this severe asthma population, the study sample will include all patients who received at least one dose of mepolizumab.

Description

Inclusion Criteria:

1) Initiated on mepolizumab for treatment of asthma.

Exclusion Criteria:

1) Participation in an interventional clinical trial in which the treatment regimen and/or monitoring is dictated by a protocol in the study observation period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients treated with mepolizumab
Drug: Mepolizumab 100 MG
Treatment with mepolizumab for severe asthma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change from baseline rate of annualized asthma exacerbations 1 year after initiation with mepolizumab
Time Frame: 1 year
The change from baseline rate of annualized asthma exacerbations 1 year after initiation with mepolizumab
1 year
The change from baseline maintenance oral corticosteroid dose (mg/day, predinisone equivalents) 1 year after initiation with mepolizumab
Time Frame: 1 year
The change from baseline maintenance oral corticosteroid dose (mg/day, predinisone equivalents) 1 year after initiation with mepolizumab
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical and patient reported measures of asthma control (ACT and/or ACQ) in the periods before and after initiation with mepolizumab
Time Frame: 1 year
Clinical and patient reported measures of asthma control (ACT and/or ACQ) in the periods before and after initiation with mepolizumab
1 year
The change from baseline measures of healthcare utilisation (number of hospitalisations and emergency department visits) 1 year after initiation with mepolizumab
Time Frame: 1 year
The change from baseline measures of healthcare utilisation (number of hospitalisations and emergency department visits) 1 year after initiation with mepolizumab
1 year
Proportion of patients who stop mepolizumab after 1 year after initiation
Time Frame: 1 year
Proportion of patients who stop mepolizumab after 1 year after initiation
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Centre Leeuwarden

Collaborators

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

June 21, 2022

First Submitted That Met QC Criteria

June 27, 2022

First Posted (Actual)

July 1, 2022

Study Record Updates

Last Update Posted (Actual)

July 1, 2022

Last Update Submitted That Met QC Criteria

June 27, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 212821

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD is not available in this study due to the federated analysis of data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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