EUCTR2008-005045-34-IE进行中（未招募）不适用
A double-blind, vehicle-controlled, multi-centre, clinical study to investigate the efficacy and safety of up to 6 months of therapy with inhaled Promixin in the treatment of patients with non-cystic fibrosis bronchiectasis infected with Pseudomonas aeruginosa susceptible to Promixin - Inhaled Promixin in the treatment of non-CF bronchiectasis
Profile Pharma Ltd0 个研究点目标入组 260 人开始时间: 2010年5月18日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 260
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
- •At Screening (Visit 1)
- •1. Aged 18 years and over.
- •2. Have had P. aeruginosa grown from their sputum at least twice in the 12 months preceding the screening visit.
- •3. Be within 21 days of completing a course of anti-pseudomonal antibiotics for the successful treatment of an exacerbation.
- •4. Able and willing to give informed consent, following a detailed explanation of participation in the protocol and signed consent obtained.
- •5. Diagnosed with non-CF bronchiectasis by computerised tomography (CT) and recorded in the patient’s notes.
- •At Randomisation/Baseline (Visit 2)
- •6. P. aeruginosa grown from patients’ sputa taken at Visit 1 (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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •At Screening (Visit 1)
- •1. Known on history to have cystic fibrosis (CF).
- •2. Known on history to have hypogammaglobulinaemia, inflammatory bowel disease, primary ciliary dyskinesia or myloproliferative disease.
- •3. Confirmed, recent, active allergic bronchopulmonary aspergillosis (ABPA).
- •4. Significant immune suppression that would interfere with the interpretation of the study e.g. current active malignancy requiring treatment, post solid organ or bone marrow transplant.
- •5. Known on history, to have HIV, hepatitis B or hepatitis C.
- •6. Evidence of bronchoreactivity that may, in the opinion of the investigator, indicate that such patients will not be able to tolerate colistimethate sodium.
- •7. Not able to tolerate inhaled beta agonists.
- •8. Allergic to or unable to tolerate colistimethate sodium.
- •9. Known on history, to have received prophylactic inhaled colistimethate sodium prior to screening. (Note: Previous use of other inhaled anti-pseudomonal antibiotics, such as gentamycin and/or tobramycin, does not exclude a patient from the study)
- •10. Requiring therapy with steroids excepting a stable dose of 15 mg a day or less.
- •11. Taking anti tumour necrosis factor alpha products.
- •12. New maintenance azithromycin therapy started with in 6 months of Visit 1.
- •13. Taking hypertonic saline.
- •14. Pregnant or breast feeding or who plan to become pregnant over the next year or of child bearing potential and unwilling to use a reliable method of contraception (oral contraceptive pills (OCP) or barrier methods with a spermicidal preparation) throughout their involvement in the study.
- •15. In the opinion of the investigator are not suitable for inclusion for whatever reason.
- •16. Do not have access to a telephone for telephone contacts.
- •At Randomisation/Baseline (Visit 2) patients who satisfy one or more of the following criteria will be withdrawn:
- •17. Use of inhaled antibiotics since screening.
- •18. A =15% fall in FEV1 in the 30 minutes after receiving the first dose of IMP.
- •19. Haematology and biochemistry test results make the patient unsuitable for the study in the opinion of the investigator.
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