Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 9:49 AM
Study NCT ID:
NCT05441059
Status:
COMPLETED
Last Update Posted:
2022-07-01
First Post:
2022-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Nucala in Severe Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C434107', 'term': 'mepolizumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-27', 'studyFirstSubmitDate': '2022-06-21', 'studyFirstSubmitQcDate': '2022-06-27', 'lastUpdatePostDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change from baseline rate of annualized asthma exacerbations 1 year after initiation with mepolizumab', 'timeFrame': '1 year', 'description': 'The change from baseline rate of annualized asthma exacerbations 1 year after initiation with mepolizumab'}, {'measure': 'The change from baseline maintenance oral corticosteroid dose (mg/day, predinisone equivalents) 1 year after initiation with mepolizumab', 'timeFrame': '1 year', 'description': 'The change from baseline maintenance oral corticosteroid dose (mg/day, predinisone equivalents) 1 year after initiation with mepolizumab'}], 'secondaryOutcomes': [{'measure': 'Clinical and patient reported measures of asthma control (ACT and/or ACQ) in the periods before and after initiation with mepolizumab', 'timeFrame': '1 year', 'description': 'Clinical and patient reported measures of asthma control (ACT and/or ACQ) in the periods before and after initiation with mepolizumab'}, {'measure': 'The change from baseline measures of healthcare utilisation (number of hospitalisations and emergency department visits) 1 year after initiation with mepolizumab', 'timeFrame': '1 year', 'description': 'The change from baseline measures of healthcare utilisation (number of hospitalisations and emergency department visits) 1 year after initiation with mepolizumab'}, {'measure': 'Proportion of patients who stop mepolizumab after 1 year after initiation', 'timeFrame': '1 year', 'description': 'Proportion of patients who stop mepolizumab after 1 year after initiation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma Severe Persistent Uncontrolled']}, 'referencesModule': {'references': [{'pmid': '16423202', 'type': 'BACKGROUND', 'citation': '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': '22901886', 'type': 'BACKGROUND', 'citation': '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': '32241829', 'type': 'BACKGROUND', 'citation': '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': '25199059', 'type': 'BACKGROUND', 'citation': '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': '32817259', 'type': 'BACKGROUND', 'citation': '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': '27733282', 'type': 'BACKGROUND', 'citation': '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': '28395936', 'type': 'BACKGROUND', 'citation': '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': '25199060', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nNUCALA (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.\n\nThe 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.\n\nReal 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\) Initiated on mepolizumab for treatment of asthma.\n\nExclusion Criteria:\n\n1\\) Participation in an interventional clinical trial in which the treatment regimen and/or monitoring is dictated by a protocol in the study observation period.'}, 'identificationModule': {'nctId': 'NCT05441059', 'acronym': 'UNISA', 'briefTitle': 'Use of Nucala in Severe Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Frisius Medisch Centrum'}, 'officialTitle': 'Evaluation of Real World Use of Nucala in Severe Asthma Patients From the Severe Heterogenous Asthma Research Patient-centred Collaboration (SHARP)', 'orgStudyIdInfo': {'id': '212821'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated with mepolizumab', 'description': 'Patients treated with mepolizumab', 'interventionNames': ['Drug: Mepolizumab 100 MG']}], 'interventions': [{'name': 'Mepolizumab 100 MG', 'type': 'DRUG', 'description': 'Treatment with mepolizumab for severe asthma', 'armGroupLabels': ['Patients treated with mepolizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8934 AD', 'city': 'Leeuwarden', 'state': 'Provincie Friesland', 'country': 'Netherlands', 'facility': 'Medical Centre Leeuwarden', 'geoPoint': {'lat': 53.20271, 'lon': 5.80973}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD is not available in this study due to the federated analysis of data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Frisius Medisch Centrum', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}