NL-OMON48850已完成3 期
A double-blind, placebo-controlled, multi-centre, 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 bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Zambon SpA
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Subjects can be included in the trial if they meet all the inclusion criteria
- •listed below:, 1. are able and willing to give informed consent following a
- •detailed explanation of participation in the protocol and signed consent
- •2. are aged 18 years or older of either gender;
- •3. diagnosed with NCFB by computerised tomography (CT) or high resolution CT
- •(HRCT) as recorded in the subject*s notes;
- •4. had at least 2 NCFB pulmonary exacerbations requiring oral 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 *30% of predicted;
- •8. had a positive sputum culture for P. aeruginosa from an adequate sample
- •taken at the Screening Visit (Visit 1).
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 immuno-competent by the
- •Investigator;
- •3. myasthenia gravis, porphyria or myeloproliferative disease;
- •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 allergic bronchopulmonary aspergillosis (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. predominant lung condition being chronic obstructive pulmonary disease
- •(COPD), asthma or interstitial lung disease in the opinion of the Investigator;
- •9. respiratory failure requiring long-term domiciliary oxygen therapy or
- •non-invasive ventilation;
- •10. current active malignancy, except for basal cell carcinoma of the skin
- •without metastases;
- •11. taking immunosuppressive medications (such as azathioprine, methotrexate,
- •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);
- •12. known history of human immunodeficiency virus (HIV);
- •13. current diagnosis or current treatment for non-tuberculous mycobacterial
- •(NTM) pulmonary disease or Mycobacterium tuberculosis infection;
- •14. known to be intolerant to inhaled beta-2 agonists (bronchodilators);
- •15. known or suspected to be allergic or unable to tolerate colistimethate
- •sodium (intravenous or inhaled) or other polymixins, including previous
- •evidence of bronchial hyperreactivity following inhaled colistimethate sodium;
- •16. treatment with long term (* 30 days) prednisone at a dose greater than 15
- •mg a day (or equivalent dose of any other corticosteroid) within 6 months of
- •the Screening Visit 1 (Visit 1);
- •17. new maintenance treatment with oral macrolides (e.g.
- •azithromycin/erythromycin/clarithromycin) started within 30 days of the
- •Screening Visit (Visit 1) or started between Visit 1 and Visit 2;
- •18. use of any intravenous or intramuscular or oral or inhaled anti-pseudomonal
- •antibiotic (except chronic oral macrolide treatment with a stable dose) within
- •30 days prior to the Screening Visit (Visit 1) and between Visit 1 and Visit 2;
- •19. 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;
- •20. significant abnormality in clinical evaluations and/or laboratory tests
- •(physical examination, vital signs, haematology, clinical chemistry, clinically
- •relevant impaired renal function, defined as serum creatinine levels *2.0x
- •upper limit of normal, ECG) endangering the
研究者
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