Use of Nucala in Severe Asthma

NCT05441059 | Completed

• 1 other identifier: 212821
• Study Type: observational
• Target: 2,100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma Severe Persistent Uncontrolled

Outcome Measures

Primary Outcomes (2)

• The change from baseline rate of annualized asthma exacerbations 1 year after initiation with mepolizumab

  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

  The change from baseline maintenance oral corticosteroid dose (mg/day, predinisone equivalents) 1 year after initiation with mepolizumab

  1 year

Secondary Outcomes (3)

• 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

  1 year

• Proportion of patients who stop mepolizumab after 1 year after initiation

  1 year

Study Arms (1)

Patients treated with mepolizumab

Patients treated with mepolizumab

Drug: Mepolizumab 100 MG

Interventions

Mepolizumab 100 MG DRUG

Treatment with mepolizumab for severe asthma

Patients treated with mepolizumab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \) Initiated on mepolizumab for treatment of asthma.

You may not qualify if:

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

Sponsors & Collaborators

• Frisius Medisch Centrum: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Medical Centre Leeuwarden

Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

Location

Related Publications (8)

• Simpson JL, Scott R, Boyle MJ, Gibson PG. Inflammatory subtypes in asthma: assessment and identification using induced sputum. Respirology. 2006 Jan;11(1):54-61. doi: 10.1111/j.1440-1843.2006.00784.x.

  PMID: 16423202 BACKGROUND

• Pavord ID, Korn S, Howarth P, Bleecker ER, Buhl R, Keene ON, Ortega H, Chanez P. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012 Aug 18;380(9842):651-9. doi: 10.1016/S0140-6736(12)60988-X.

  PMID: 22901886 BACKGROUND

• Taille C, Chanez P, Devouassoux G, Didier A, Pison C, Garcia G, Charriot J, Bouee S, Gruber A, Pribil C, Bourdin A, Humbert M. Mepolizumab in a population with severe eosinophilic asthma and corticosteroid dependence: results from a French early access programme. Eur Respir J. 2020 Jun 25;55(6):1902345. doi: 10.1183/13993003.02345-2019. Print 2020 Jun.

  PMID: 32241829 BACKGROUND

• Ortega HG, Liu MC, Pavord ID, Brusselle GG, FitzGerald JM, Chetta A, Humbert M, Katz LE, Keene ON, Yancey SW, Chanez P; MENSA Investigators. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014 Sep 25;371(13):1198-207. doi: 10.1056/NEJMoa1403290. Epub 2014 Sep 8.

  PMID: 25199059 BACKGROUND

• Harrison T, Canonica GW, Chupp G, Lee J, Schleich F, Welte T, Valero A, Gemzoe K, Maxwell A, Joksaite S, Yang S, Howarth P, Van Dyke MK. Real-world mepolizumab in the prospective severe asthma REALITI-A study: initial analysis. Eur Respir J. 2020 Oct 15;56(4):2000151. doi: 10.1183/13993003.00151-2020. Print 2020 Oct.

  PMID: 32817259 BACKGROUND

• GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6.

  PMID: 27733282 BACKGROUND

• Chupp GL, Bradford ES, Albers FC, Bratton DJ, Wang-Jairaj J, Nelsen LM, Trevor JL, Magnan A, Ten Brinke A. Efficacy of mepolizumab add-on therapy on health-related quality of life and markers of asthma control in severe eosinophilic asthma (MUSCA): a randomised, double-blind, placebo-controlled, parallel-group, multicentre, phase 3b trial. Lancet Respir Med. 2017 May;5(5):390-400. doi: 10.1016/S2213-2600(17)30125-X. Epub 2017 Apr 5.

  PMID: 28395936 BACKGROUND

• Bel EH, Wenzel SE, Thompson PJ, Prazma CM, Keene ON, Yancey SW, Ortega HG, Pavord ID; SIRIUS Investigators. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014 Sep 25;371(13):1189-97. doi: 10.1056/NEJMoa1403291. Epub 2014 Sep 8.

  PMID: 25199060 BACKGROUND

MeSH Terms

Interventions

mepolizumab

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: July 1, 2022
• Study Start: January 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)