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Mepolizumab Effectiveness in Severe Eosinophilic Asthma and Bronchiectasis

11 de enero de 2022 actualizado por: Raffaele Campisi, Policlinico Universitario, Catania

Mepolizumab Effectiveness in Patients With Severe Eosinophilic Asthma and Co-presence of Bronchiectasis

Asthma is a chronic respiratory disorder characterized by bronchial inflammation and reversible bronchial obstruction. Severe asthma is an extremely heterogeneous disease, often associated with several comorbidities and risk factors. Severe uncontrolled asthma associated with bronchiectasis is an emerging phenotype. Several studies have attempted to establish an association between asthma and bronchiectasis. Mepolizumab, an Interleukin-5 (IL-5) antagonist, reduces exacerbations, eosinophils, and improves pulmonary function and asthma control. IL-5 is pivotal to eosinophils maturation and release from bone marrow, their subsequent accumulation, activation and persistence in the tissues. IL-5 therefore represents an attractive target to prevent or blunt eosinophils-mediated inflammation. The investigators hypothesize that eosinophils, stimulated by IL-5, play a crucial role in severe asthma and BE pathogenesis.

Descripción general del estudio

Estado

Reclutamiento

Intervención / Tratamiento

Descripción detallada

Asthma is a chronic respiratory disorder in which bronchial inflammation, airway hyperresponsiveness, and reversible bronchial obstruction are operant, inciting daily symptoms and triggering unpredictable acute exacerbations. The prevalence of severe asthma varies between 5 and 10% of asthma frameworks and is estimated to account for >60% of the total costs of the disease. Severe asthma warrants Global Initiative for Asthma (GINA) Step 4 or 5 treatment, (e.g. high-dose Inhaled Corticosteroids/Long Acting Beta2-Agonists (ICS/LABA), to achieve control or remains 'uncontrolled' (entirely or in part) despite this or other appropriate therapeutic intervention. Severe asthma is an extremely heterogeneous disease, often associated with several comorbidities and risk factors, leading to divide accordingly severe asthmatic patients into homogenous groups. The result is the identification of several phenotypes of severe asthma, as those associated with obesity, smoking habit, chronic obstructive pulmonary disease (COPD), gastro-oesophageal reflux disease (GERD), chronic rhinosinusitis, nasal polyposis, infections and others. In recent years, the recognition and treatment of comorbidities is crucial because can potentially improve asthma control and outcomes. Severe uncontrolled asthma associated with bronchiectasis is an emerging phenotype. Several studies have attempted to establish an association between asthma and bronchiectasis. The prevalence of bronchiectasis (BE) is significantly higher in severe asthma (range 24-40%), then in milder disease (3%). At least one third of patients with severe asthma show the presence of BE on high resolution chest computed tomography (HRCT) scan. This phenotype has been described particularly in patients with severe, late-onset eosinophilic asthma. In order to improve the therapeutic approach to the more severe forms of asthma, biological treatments have been realized. Recently, mepolizumab, an IL-5 antagonist, was commercialized. Mepolizumab reduces exacerbations, eosinophils, and improves pulmonary function and asthma control. There is a considerable evidence that implicates eosinophils as important effector cells in the eosinophilic asthma inflammation. IL-5 is pivotal to eosinophils maturation and release from bone marrow, their subsequent accumulation, activation and persistence in the tissues. IL-5 therefore represents an attractive target to prevent or blunt eosinophils-mediated inflammation. The investigators hypothesize that eosinophils, stimulated by IL-5, play a crucial role in severe asthma and BE pathogenesis. Accumulation of eosinophils at the bronchial level causes damage by degranulation and release of toxic protein, mucus hypersecretion, elastolytic activity, mucinous cells hypertrophy and oxidative stress. Airway remodeling, due to the activity of eosinophils, is the consequence of ongoing inflammation and repair. All these tissue changes are characteristic of both asthma and bronchiectasis (BE). BE, in effect, is caused by long-term excessive inflammatory damage to the airways and in patients with asthma, eosinophils may further contribute to tissue injury. The investigators therefore hypothesize that treatment with mepolizumab, targeted against IL-5 activity, in patients with severe eosinophilic asthma associated with bronchiectasis may lead to a reduction of bronchiectasis and asthma exacerbations and lead to improve control of asthma.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

100

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Raffaele Campisi, Medicine
  • Número de teléfono: +393392659722
  • Correo electrónico: raffaelemd@hotmail.it

Copia de seguridad de contactos de estudio

  • Nombre: Raffaele Campisi
  • Número de teléfono: +390953781413
  • Correo electrónico: raffaelemd@hotmail.it

Ubicaciones de estudio

      • Catania, Italia, 95125
        • Reclutamiento
        • AOU Policlinico "G. Rodolico-Sto arrivando!n Marco"
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Male and female with age greater than or equal to 18 years;
  2. Severe eosinophilic asthma diagnosis according to GINA 2019 report
  3. Evidence of bronchiectasis in at least one lung lobe in the chest CT scan performed prior to mepolizumab treatment;
  4. Presence of daily expectoration;
  5. At least 3 bronchiectasis exacerbations in the year prior to mepolizumab treatment, documented through medical documentation, which required treatment with antibiotics;
  6. Informed consent obtained from the patient.

Exclusion Criteria:

  1. Poor adherence to severe asthma therapy
  2. Patients with other respiratory disease that may share common clinical manifestations of severe asthma (i.e. acute bronchopulmonary aspergillosis, vasculitis and COPD)
  3. 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.
  4. Bronchiectasis associated with cystic fibrosis;
  5. Traction bronchiectasis in the context of pulmonary fibrosis;
  6. History of lung cancer in the previous 5 years;
  7. History of significant hemoptysis (≥300 mL of blood) or which required embolization or blood transfusions within 6 weeks prior to mepolizumab treatment;
  8. Use of drugs that can influence the response to treatment such us immunosuppressant and/or biological therapies

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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
Comparador activo: 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline of Asthma Control Test (ACT) score at Week 12 (T3), at Week 24 (T6) and at Week 52 (T12).
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from Baseline values of Spirometry values (expressed in Litre) at Week 12 (T3), at Week 24 (T6) and at Week 52 (T12).
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Raffaele Campisi, Medicine, Respiratory Unit Policlinico G. Rodolico-San Marco

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de septiembre de 2021

Finalización primaria (Anticipado)

1 de junio de 2022

Finalización del estudio (Anticipado)

31 de diciembre de 2022

Fechas de registro del estudio

Enviado por primera vez

17 de octubre de 2021

Primero enviado que cumplió con los criterios de control de calidad

11 de enero de 2022

Publicado por primera vez (Actual)

12 de enero de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de enero de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

11 de enero de 2022

Última verificación

1 de enero de 2022

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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