EUCTR2013-005366-19-PL进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 255
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 will be entered into this study only if they meet all of the following criteria:
- •1. Are willing and able to provide written informed consent.
- •2. Are males or females who are 18 year of age or older and are able to walk.
- •3. Have had a confirmed diagnosis of non-CF bronchiectasis per computerized tomography (or high resolution computerized tomography) showing bronchial wall dilatation (internal
- •bronchial lumen diameter greater than accompanying pulmonary artery or lack of tapering) with or without bronchial wall thickening.
- •4. Have a documented history of at least 2 pulmonary exacerbations
- •treated with courses of antibiotics within the last 12 months.
- •5. Have FEV1 = 25% of predicted values at the Screening Visit (Visit 0).
- •6. Have positive documented P. aeruginosa in a sputum/deep-throat
- •swab culture (or bronchoalveolar lavage [BAL] or bronchoscopic
- •specimen) prior to the Screening Visit (Visit 0). Subjects without documented P. aeruginosa prior to Screening who meet all other eligibility criteria must have at least two sputum samples or deep-throat swabs collected 3-4 or more weeks apart from each other during the 42-day Screening Phase. Two of the samples collected must test positive for P. aeruginosa. These two positive tests must be from samples taken a minimum of 3-4 or more weeks apart.
- •7. Have positive P. aeruginosa in the sputum/deep-throat swab culture
- •collected at the Screening Visit (Visit 0) and at least one P. aeruginosa isolate non-resistant to ciprofloxacin. If the sputum sample is negative for P. aeruginosa, or only shows resistant P. aeruginosa isolates, the sputum/swab culture can be repeated multiple times during Screening to document the presence of P. aeruginosa. In subjects without documented P. aeruginosa prior to Screening who meet all other eligibility criteria and who had two or more sputum cultures or deep-throat swab cultures obtained 3-4 or more weeks apart from each other during Screening, at least one P. aeruginosa isolate taken after 3-4 or more weeks must be non-resistant to ciprofloxacin for the subject to be considered eligible for randomization. The qualifying sputum culture results must be available within the 42-day Screening Phase.
- •8. Are clinically stable and capable of performing the 6mwt without
- •supplemental oxygen.
- •9. Are willing and able to comply with the requirements for
- •participation in the study.
- •10. Female subjects of childbearing potential must have a negative pregnancy test at the Screening Visit and must use an acceptable method of contraception for at least 3 months prior to the first dose of study drug and for 28 days after the last dose of study drug. Acceptable methods of contraception for women are orally administered or implantable or injectable. To be considered not of childbearing potential, female subjects must be postmenopausal for at least 1 year as confirmed by an elevated follicle-stimulating hormone (FSH) level (= 30 mIU/mL) at Screening and 1 year of amenorrhea, or
- •have been irreversibly surgically sterilized by hysterectomy,
- •oophorectomy, or bilateral tubal ligation for at least 3 months prior to
- •the first dose of study drug. Male subjects whose female partners are of
- •childbearing potential (definition as above) must agree to use an
- •acceptable method of birth control for the duration of study treatment
- •and for 28 days after the last dose of study drug.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
排除标准
- •Subjects will be randomized into this study only if they meet none of the following criteria:
- •1. Have a pulmonary exacerbation during the Screening Phase (between signing the ICF and randomization), defined as requiring acute treatment with inhaled, oral, or intravenous antibiotics.
- •2. Have a clinical diagnosis of CF.
- •3. Have primary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) related to smoking history of greater than 10 pack years.
- •4. Have a current diagnosis of active allergic bronchopulmonary aspergillosis.
- •5. Have received any intravenous, oral, or inhaled anti-pseudomonal antibiotic (except chronic macrolides erythromycin, clarithromycin or azithromycin with a stable dose) within 28 days prior to Visit 1.
- •6. Have an allergy to ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin, or norfloxacin.
- •7. Have a known allergy to soy products.
- •8. Have used tizanidine within 28 days prior to Visit 1 and would need to use tizanidine during the study (because tizanidine is contraindicated due to a PK interaction with ciprofloxacin).
- •9. Have initiated supplemental oxygen within 28 days prior to Visit 1.
- •10. Have used any intravenous or intramuscular corticosteroid or have used oral corticosteroid > 10 mg/day or > 20 mg every other day (prednisone or prednisolone equivalents) within 28 days of Visit 1.
- •11. Have had changes in either the treatment regimen or initiation of treatment with any of the following medications within 28 days prior to Visit 1:
- •a. Macrolides, e.g., azithromycin, clarithromycin or erythromycin
- •b. Inhaled hypertonic saline or inhaled mannitol
- •c. Mucolytics
- •d. Bronchodilator medications
- •e. Oral corticosteroid
- •12. Have had changes in pulmonary rehabilitation, chest physiotherapy technique or frequency within 28 days prior to Visit 1.
- •13. Have a history of solid organ (e.g., lung) transplantation.
- •14. Have a non-tuberculosis mycobacterial infection and are currently receiving antibiotic treatment or are anticipated to require initiation of antibiotic treatment during the study.
- •15. Have active tuberculosis.
- •16. Have serum creatinine levels = 2.0x upper limit of normal (ULN) at the Screening Visit (Visit 0).
- •17. Have serum transaminase levels > 3x ULN at the Screening Visit (Visit 0).
- •18. Have a febrile illness within 1 week prior to Visit 1.
- •19. Have had massive hemoptysis (greater than or equal to 300 mL or requiring blood transfusion) within 6 months prior to Visit 1.
- •20. Have received an investigational drug or device within 42 days prior to Visit 1.
- •21. Have a malignancy or any other serious or active medical illness with a life expectancy of less than 12 months.
- •22. Have any serious or active medical or psychiatric illness, which in the opinion of the Investigator, would interfere with subjects’ treatment, assessment, or compliance with the protocol.
- •23. Have a history or suspicion of unreliability, poor cooperation, or non-compliance with medical treatment.
- •24. Are unable to use nebulizers during the course of the study.
- •25. Are unable either to understand the instruction for use of the study drug or to complete the Quality of Life Questionnaire-Bronchiectasis (QoL-B) at Visit 1.
- •26. Have previously been randomized in this study.
- •27. Are pregnant, plan to become pregnant during this study, are nursing mothers or are unwilling to use an acceptable method of contraception for the duration of the study.
- •28. Have any other condition that, in the opinion of the Investigator, would prohibit the subject from
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