NCT05441059|Completed
Use of Nucala in Severe Asthma
UNISA
Evaluation of Real World Use of Nucala in Severe Asthma Patients From the Severe Heterogenous Asthma Research Patient-centred Collaboration (SHARP)
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UNISA
Evaluation of Real World Use of Nucala in Severe Asthma Patients From the Severe Heterogenous Asthma Research Patient-centred Collaboration (SHARP)
Sponsor study identifier
observational
2,100
1 country
1
Study Start
January 1, 2021
Actual (reported)Primary Completion
May 1, 2022
Actual (reported)Study Completion
May 1, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2021
Actual (reported)May 1, 2022
Actual (reported)May 1, 2022
Actual (reported)June 21, 2022
Actual (reported)July 1, 2022
Actual (reported)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
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
Patients treated with mepolizumab
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.
Medical Centre Leeuwarden
Leeuwarden, Provincie Friesland, 8934 AD, Netherlands
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.
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.
2,100 participants (actual enrollment reported by the registry).
First Submitted
June 21, 2022
First Posted
July 1, 2022
Study Start
January 1, 2021
Actual (reported)Mepolizumab Effectiveness in Severe Eosinophilic Asthma and Bronchiectasis
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
Primary Completion
May 1, 2022
Actual (reported)Study Completion
May 1, 2022
Actual (reported)Last Updated
July 1, 2022
Record last verified: 2022-06
IPD is not available in this study due to the federated analysis of data.
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Source: ClinicalTrials.gov.
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