EUCTR2015-002743-33-ES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 Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I
Zambon S.p.A.0 个研究点目标入组 264 人开始时间: 2017年2月10日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 264
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
- •Subjects can be included in the trial if they meet all 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 obtained;
- •2. Aged 18 years or older of either genders;
- •3. Diagnosed with non-CF bronchiectasis by computerised tomography (or high resolution CT) and recorded in the subject’s notes;
- •4. Had at least 2 NCFB pulmonary exacerbations requiring oral antibiotics or 1 pulmonary exacerbation requiring intravenous antibiotics in the 12 months preceding the Screening Visit (Visit 1);
- •5. Had 1 positive sputum culture for P. aeruginosa in the 12 months preceding the Screening Visit (but performed at least 30 days before the Screening Visit);
- •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).
- •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 132
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 132
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) or focal endobronchial lesion or otherwise curable causes (e.g. foreign body aspiration);
- •2. known history of hypogammaglobulinaemia requiring treatment with immunoglobulin, inflammatory bowel disease, primary ciliary dyskinesia, myasthenia gravis, porphyria or myeloproliferative disease, severe cardiovascular disease;
- •3. a major abdominal, chest or brain surgery in the 3 months prior to Screening Visit (Visit 1) or planned inpatient major surgery during the study period;
- •4. receiving treatment for allergic bronchopulmonary aspergillosis (ABPA);
- •5. massive haemoptysis (greater than or equal to 300 mL or requiring blood transfusion) in the preceding 4 weeks before Screening Visit (Visit 1);
- •6. predominant lung condition being chronic obstructive pulmonary disease (COPD) or asthma or interstitial lung disease in the opinion of the Investigator;
- •7. History of any of the following:
- •- listed for transplantation;
- •- any other significant active illness likely to affect the patient’s survival within 12 months;
- •- receiving long-term domiciliary oxygen therapy or non-invasive ventilation for the management of respiratory failure;
- •8. current active malignancy, except for basal cell carcinoma of the skin without metastases, history of solid organ or bone marrow transplant;
- •9. taking immunosuppressive medications such as azathioprine, methotrexate, ciclosporine, tacrolimus, sirolimus, mycophenolate, anti cytokine medications, rituximab;
- •10. known history of human immunodeficiency virus (HIV), hepatitis B or C;
- •11. current diagnosis of Mycobacterium tuberculosis infection;
- •12. positive cultures for Mycobacterium abscessus complex, or Mycobacterium avium complex, or Mycobacterium xenopi, or Mycobacterium kansasii, or Mycobacterium malmoense or Mycobacterium simiae in the year preceding the Screening Visit (Visit 1);
- •13. current treatment for non-tuberculous mycobacterial (NTM) pulmonary infection or be under consideration for NTM treatment in the next 12 months;
- •14. current smokers or ex-smokers less than 6 months prior to Screening Visit (Visit 1);
- •15. evidence of bronchial hyperreactivity that may, in the opinion of the Investigator, indicate such subjects will not be able to tolerate colistimethate sodium;
- •16. known to be intolerant to inhaled beta agonists (bronchodilators);
- •17. known or suspected to be allergic or unable to tolerate colistimethate sodium or other polymixins;
- •18. therapy with long term (= 30 days) prednisone at stable dose greater than 15 mg a day (or equivalent dose of any other corticosteroid) prior to Screening Visit 1 (Visit 1);
- •19. new maintenance treatment with oral macrolides (azithromycin or erythromycin) started within 30 days of the Screening Visit (Visit 1);
- •20. use of any intravenous or intramuscular or oral or inhaled antipseudomonal antibiotic (except chronic macrolides azithromycin or erythromycin with a stable dose) within 30 days prior to Screening Visit (Visit 1);
- •21. 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 throughout their involvement in the trial;
- •22. Significant abnormality in clinical evaluations and/or laboratory tests (physical examination, vital signs, haematology, clinical chemistry, ECG) endangering the safe participat
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