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Mepolizumab Effectiveness in Severe Eosinophilic Asthma and Bronchiectasis

2022년 1월 11일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (예상)

100

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

      • Catania, 이탈리아, 95125
        • 모병
        • AOU Policlinico "G. Rodolico-Sto arrivando!n Marco"
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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
활성 비교기: 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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from baseline of Asthma Control Test (ACT) score at Week 12 (T3), at Week 24 (T6) and at Week 52 (T12).
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change from Baseline values of Spirometry values (expressed in Litre) at Week 12 (T3), at Week 24 (T6) and at Week 52 (T12).
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Raffaele Campisi, Medicine, Respiratory Unit Policlinico G. Rodolico-San Marco

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 9월 1일

기본 완료 (예상)

2022년 6월 1일

연구 완료 (예상)

2022년 12월 31일

연구 등록 날짜

최초 제출

2021년 10월 17일

QC 기준을 충족하는 최초 제출

2022년 1월 11일

처음 게시됨 (실제)

2022년 1월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 1월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 1월 11일

마지막으로 확인됨

2022년 1월 1일

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