- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT05189613
Mepolizumab Effectiveness in Severe Eosinophilic Asthma and Bronchiectasis
Mepolizumab Effectiveness in Patients With Severe Eosinophilic Asthma and Co-presence of Bronchiectasis
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Raffaele Campisi, Medicine
- Telefoonnummer: +393392659722
- E-mail: raffaelemd@hotmail.it
Studie Contact Back-up
- Naam: Raffaele Campisi
- Telefoonnummer: +390953781413
- E-mail: raffaelemd@hotmail.it
Studie Locaties
-
-
-
Catania, Italië, 95125
- Werving
- AOU Policlinico "G. Rodolico-Sto arrivando!n Marco"
-
Contact:
- Raffaele Campisi
- Telefoonnummer: +390953781413
- E-mail: raffaelemd@hotmail.it
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Male and female with age greater than or equal to 18 years;
- Severe eosinophilic asthma diagnosis according to GINA 2019 report
- Evidence of bronchiectasis in at least one lung lobe in the chest CT scan performed prior to mepolizumab treatment;
- Presence of daily expectoration;
- At least 3 bronchiectasis exacerbations in the year prior to mepolizumab treatment, documented through medical documentation, which required treatment with antibiotics;
- Informed consent obtained from the patient.
Exclusion Criteria:
- Poor adherence to severe asthma therapy
- Patients with other respiratory disease that may share common clinical manifestations of severe asthma (i.e. acute bronchopulmonary aspergillosis, vasculitis and COPD)
- Any medical condition or disease that was not stable during the 3 months prior to mepolizumab treatment (excluding asthma exacerbations), that the investigator believes may compromise the safety of the patient if enrolled in the study such us atrial fibrillation, acute respiratory failure, acute heart failure, myocardial infarction and acute renal failure.
- Bronchiectasis associated with cystic fibrosis;
- Traction bronchiectasis in the context of pulmonary fibrosis;
- History of lung cancer in the previous 5 years;
- History of significant hemoptysis (≥300 mL of blood) or which required embolization or blood transfusions within 6 weeks prior to mepolizumab treatment;
- Use of drugs that can influence the response to treatment such us immunosuppressant and/or biological therapies
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Severe Asthma+BE
Patients with severe eosinophilic asthma with co-presence of Bronchiectasis (BE) in treatment with Mepolizumab
|
Subcutaneous Mepolizumab (100 mcg) injection in patients with severe eosinophilic asthma
|
|
Actieve vergelijker: Severe Asthma without BE
Patients with severe eosinophilic asthma without Bronchiectasis (BE) in treatment with Mepolizumab
|
Subcutaneous Mepolizumab (100 mcg) injection in patients with severe eosinophilic asthma
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from baseline of Asthma Control Test (ACT) score at Week 12 (T3), at Week 24 (T6) and at Week 52 (T12).
Tijdsspanne: Baseline and Week 52
|
Asthma Control Test (ACT) score is validated five-points scoring system, self-administered assessing the control of Asthma. Scores range from 5 points (worst asthma control) to 25 points (better asthma control). Change = Week 12 (T3) - Baseline score; Week 24 (T6) - Baseline score; Week 52 (T12) - Baseline score. |
Baseline and Week 52
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from Baseline values of Spirometry values (expressed in Litre) at Week 12 (T3), at Week 24 (T6) and at Week 52 (T12).
Tijdsspanne: Baseline and Week 52
|
Spirometry assess the airways obstruction. Spirometry will be performed according to American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines. The main benchmarks for assessing airways obstruction are: Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC), expressed in Litre (L) respectively. Change = Week 12 (T3) - Baseline values; Week 24 (T6) - Baseline values; Week 52 (T12) - Baseline values. |
Baseline and Week 52
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Raffaele Campisi, Medicine, Respiratory Unit Policlinico G. Rodolico-San Marco
Publicaties en nuttige links
Algemene publicaties
- Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk PJ, Adcock IM, Bateman ED, Bel EH, Bleecker ER, Boulet LP, Brightling C, Chanez P, Dahlen SE, Djukanovic R, Frey U, Gaga M, Gibson P, Hamid Q, Jajour NN, Mauad T, Sorkness RL, Teague WG. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014 Feb;43(2):343-73. doi: 10.1183/09031936.00202013. Epub 2013 Dec 12. Erratum In: Eur Respir J. 2014 Apr;43(4):1216. Dosage error in article text. Eur Respir J. 2018 Jul 27;52(1): Eur Respir J. 2022 Jun 9;59(6):
- Crimi C, Campisi R, Cacopardo G, Intravaia R, Nolasco S, Porto M, Pelaia C, Crimi N. Real-life effectiveness of mepolizumab in patients with severe refractory eosinophilic asthma and multiple comorbidities. World Allergy Organ J. 2020 Sep 18;13(9):100462. doi: 10.1016/j.waojou.2020.100462. eCollection 2020 Sep.
- Bardin PG, Rangaswamy J, Yo SW. Managing comorbid conditions in severe asthma. Med J Aust. 2018 Jul 16;209(S2):S11-S17. doi: 10.5694/mja18.00196.
- Perez-Miranda J, Traversi L, Polverino E. Bronchiectasis in severe asthma: a distinct phenotype? Curr Opin Pulm Med. 2019 Jan;25(1):71-78. doi: 10.1097/MCP.0000000000000542.
- Carpagnano GE, Scioscia G, Lacedonia D, Curradi G, Foschino Barbaro MP. Severe uncontrolled asthma with bronchiectasis: a pilot study of an emerging phenotype that responds to mepolizumab. J Asthma Allergy. 2019 Mar 5;12:83-90. doi: 10.2147/JAA.S196200. eCollection 2019.
- Padilla-Galo A, Olveira C, Fernandez de Rota-Garcia L, Marco-Galve I, Plata AJ, Alvarez A, Rivas-Ruiz F, Carmona-Olveira A, Cebrian-Gallardo JJ, Martinez-Garcia MA. Factors associated with bronchiectasis in patients with uncontrolled asthma; the NOPES score: a study in 398 patients. Respir Res. 2018 Mar 16;19(1):43. doi: 10.1186/s12931-018-0746-7.
- Dimakou K, Gousiou A, Toumbis M, Kaponi M, Chrysikos S, Thanos L, Triantafillidou C. Investigation of bronchiectasis in severe uncontrolled asthma. Clin Respir J. 2018 Mar;12(3):1212-1218. doi: 10.1111/crj.12653. Epub 2017 Jun 8.
- Pelaia C, Crimi C, Vatrella A, Tinello C, Terracciano R, Pelaia G. Molecular Targets for Biological Therapies of Severe Asthma. Front Immunol. 2020 Nov 30;11:603312. doi: 10.3389/fimmu.2020.603312. eCollection 2020.
- Pelaia C, Crimi C, Pelaia G, Nolasco S, Campisi R, Heffler E, Valenti G, Crimi N. Real-life evaluation of mepolizumab efficacy in patients with severe eosinophilic asthma, according to atopic trait and allergic phenotype. Clin Exp Allergy. 2020 Jul;50(7):780-788. doi: 10.1111/cea.13613. Epub 2020 May 13.
- Polverino E, Dimakou K, Hurst J, Martinez-Garcia MA, Miravitlles M, Paggiaro P, Shteinberg M, Aliberti S, Chalmers JD. The overlap between bronchiectasis and chronic airway diseases: state of the art and future directions. Eur Respir J. 2018 Sep 15;52(3):1800328. doi: 10.1183/13993003.00328-2018. Print 2018 Sep.
- Kaur R, Chupp G. Phenotypes and endotypes of adult asthma: Moving toward precision medicine. J Allergy Clin Immunol. 2019 Jul;144(1):1-12. doi: 10.1016/j.jaci.2019.05.031.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van de luchtwegen
- Ziekten van het immuunsysteem
- Longziekten
- Overgevoeligheid, Onmiddellijk
- Hematologische ziekten
- Bronchiale ziekten
- Longziekten, obstructief
- Ademhalingsovergevoeligheid
- Overgevoeligheid
- Leukocytenstoornissen
- Eosinofilie
- Hypereosinofiel syndroom
- Bronchiëctasie
- Astma
- Pulmonale eosinofilie
Andere studie-ID-nummers
- PoliclinicoUC
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .