EUCTR2016-004558-13-IT进行中（未招募）1 期
A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasischronically infected with Pseudomonas aeruginosa (P. aeruginosa) - Promis II
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ZAMBON SPA
- 入组人数
- 420
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) are able and willing to give informed consent, following a detailed
- •explanation of participation in the protocol and signed consent obtained;
- •2) are aged 18 years or older of either gender;
- •3) are diagnosed with NCFB by CT (or high-resolution CT) as recorded in the subject's notes and this is their predominant condition being
- •4) had at least 2 NCFB pulmonary exacerbations requiring oral or
- •inhaled antibiotics or 1 NCFB pulmonary exacerbation requiring
- •intravenous antibiotics in the 12 months preceding the Screening Visit
- •(Visit 1) and had no NCFB pulmonary exacerbation with or without
- •treatment during the period between Visit 1 and Visit 2;
- •5) have a documented history of P. aeruginosa infection;
- •6) are clinically stable and have not required a change in pulmonary
- •treatment for at least 30 days before the Screening Visit (Visit 1);
- •7) have pre-bronchodilator FEV1 =25% of predicted;
- •8) had a positive sputum culture for P. aeruginosa from an adequate
- •sample taken at the Screening Visit (Visit 1) or during the screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 210
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 208
排除标准
- •Subjects are not eligible for the trial if they meet one or more of the
- •exclusion criteria listed below:
- •1) known bronchiectasis as a consequence of cystic fibrosis (CF);
- •2) known history of hypogammaglobulinaemia requiring treatment with
- •immunoglobulin, unless fully replaced and considered immunocompetent
- •by the Investigator;
- •3) myasthenia gravis or porphyria;
- •4) severe cardiovascular disease such as severe uncontrolled
- •hypertension, ischaemic heart disease or cardiac arrhythmia and any
- •other conditions that would confound the evaluation of safety, in the
- •opinion of the Investigator;
- •5) had major surgery in the 3 months prior to the Screening Visit (Visit
- •1) or planned inpatient major surgery during the study period;
- •6) receiving treatment for ABPA;
- •7) had massive haemoptysis (greater than or equal to 300 mL or
- •requiring blood transfusion) in the preceding 4 weeks before the
- •Screening Visit (Visit 1) or between Visit 1 and Visit 2;
- •8) respiratory failure that would compromise patient safety or
- •confound the evaluation of safety or efficacy of the study in the opinion
- •of the Investigator;
- •9) current active malignancy, except for basal cell carcinoma or
- •squamous cell carcinoma of the skin without metastases;
- •10) taking immunosuppressive medications (such as azathioprine,
- •cyclosporine, tacrolimus, sirolimus, mycophenolate, rituximab), and/or
- •anti-cytokine medications (such as anti-IL-6 and anti-tumour alpha
- •necrosis factor products) in the preceding year before the Screening
- •Visit (Visit 1);
- •11) known history of human immunodeficiency virus (HIV);
- •12) current treatment for non-tuberculous mycobacterial (NTM) lung
- •disease or tuberculosis;
- •13) known or suspected to be allergic or unable to tolerate
- •colistimethate sodium (intravenous or inhaled) or other polymixins,
- •including evidence of bronchial hyper-reactivity following inhaled
- •colistimethate sodium;
- •14) treatment with long term (= 30 days) prednisone at a dose of
- •greater than 15 mg a day (or equivalent dose of any other
- •corticosteroid) within six months of the Screening Visit (Visit 1);
- •15) new maintenance treatment with any oral macrolides (e.g.
- •azithromycin/erythromycin/clarithromycin) within 30 days of the
- •Screening Visit (Visit 1) or started between Visit 1 and Visit 2;
- •16) use of any intravenous or intramuscular or oral or inhaled antipseudomonal
- •antibiotic (except chronic macrolides with a stable dose) within 30 days prior to the Screening Visit (Visit 1) and between Visit 1
- •and Visit 2;
- •17) pregnant or breast-feeding or plan to become pregnant over the
- •next year or of child-bearing potential and unwilling to use a reliable
- •method of contraception for at least one month before randomisation
- •and throughout their involvement in the trial;
研究者
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