NCT02273661已完成2 期
Evaluation of a Therapeutic Strategy Including Nebulised Liposomal Amphotericin B (Ambisome®) in Maintenance Treatment of Allergic Bronchopulmonary Aspergillosis (Cystic Fibrosis Excluded)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- occurrence of first severe clinical exacerbation
研究概览
简要总结
Compare the incidence of severe clinical exacerbations in the treatment of ABPA, between a strategy with a maintenance treatment and a conventional strategy without antifungal maintenance therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with ABPA justifying an attack treatment with corticosteroids and itraconazole and combining the following criteria:
- •atopic subject or a history of asthma , history of total Immunoglobin E (IgE)> 417 kU / L (or > 210 kU / L with a clear worsening) of a known ABPA), specific Immunoglobin E against Aspergillus fumigatus positive ( >0.35 KUA/L) or positive skin tests.
- •associated with two other of the following criteria: documentation of precipitating antibodies or Immunoglobulin G positive to Aspergillus fumigatus, of radiological infiltrates associated with ABPA (transitional / persistent / bronchial dilation), of blood eosinophilia > 500 elements/mm
- •After informing and obtaining consent signed.
排除标准
- •Women of childbearing age who do not have an effective contraception for at least 12 first months of the study( 10 months + 2 months of treatment washout) pregnant or lactating women,
- •Patient with cystic fibrosis
- •Patient with a contra-indication to itraconazole
- •Intolerance to β2 -agonists
- •Known hypersensitivity to liposomal amphotericin B or any other component
- •Laboratory abnormalities: significant abnormalities of platelet blood count , liver function tests (SGPT, SGOT(serum glutamate oxaloacetate transaminase) , total bilirubin > 5 times the upper limit of the normal range )
- •severe renal function impairment (creatinine clearance enf to 30 ml/min)
- •Concomitant use of one or more of the following treatments: Alfuzosine, alcaloïdes de l'ergot de seigle vasoconstricteur, aliskiren, astemizole, atorvastatine, avanafil, association Ombitasvir and Paritaprevir, Bepridil, Cisaprid, Dabigatran, dapoxetin, domperidon, dronedaron, Eplerenone, Halofantrin, Ivabradin, Lomitapid, lurasidon, Millepertuis, mizolastin, Pimozid,Quétiapin, quinidin, Ranolazine, ritonavir, Sertindole, sildénafil, simvastatin, sirolimus, Sultoprid, Terfenadine, ticagrelor, triazolam Vardénafil (in men over than 75)
- •patient with anti IgE- monoclonal antibody for less than 4 months or with current complications related to previous treatment with anti IgE- monoclonal antibody -
- •Ventricular dysfunction demonstrated such as congestive heart failure or a history of congestive heart failure
- •Simple aspergilloma, chronic pulmonary aspergillosis, invasive pulmonary aspergillosis
- •Respiratory infection aggravating asthma or ABPA
研究组 & 干预措施
Control
Placebo Comparator
An aerosol of isotonic saline x 1/ week will be administered during 6 months
干预措施: placebo (Drug)
Ambisome
Experimental
An aerosol of Liposomal Amphotericin B (Ambisome®) at 25 mg x 1/ week will be administered during 6 months
干预措施: Liposomal amphotericin B (Ambisome®) (Drug)
结局指标
主要结局
occurrence of first severe clinical exacerbation
时间窗: within 24 months following the attack treatment,
Occurrence of severe clinical exacerbation within 24 months following attack treatment, defined by the onset or worsening of dyspnea aggravating the baseline condition that justified: 1. -increased inhalation treatments (inhaled bronchodilators and / or corticosteroids) * and / or initiation of systemic corticosteroid treatment * and / or hospitalization 2. AND persisting for more than 7 days.
次要结局
未报告次要终点
研究者
研究点 (1)
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