EUCTR2013-005366-19-GB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 withPseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4)
适应症
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
- •3. Have had a confirmed diagnosis of non-CF bronchiectasis per
- •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 been off any antibiotic treatment for a minimum of 28 days prior
- •to Visit 1, except for macrolides (azithromycin or erythromycin) used
- •chronically at a stable dose.
- •6. Have FEV1 = 25% of predicted values at the Screening Visit (Visit 0).
- •7. 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).
- •8. Have positive P. aeruginosa in the sputum/deep-throat swab culture
- •collected at the Screening Visit (Visit 0). If sputum sample is negative,
- •sputum/swab culture can be repeated on up to 3 occasions during
- •Screening to document P. aeruginosa presence.
- •9. Are clinically stable and capable of performing the 6mwt without
- •supplemental oxygen.
- •10. Are willing and able to comply with the requirements for
- •participation in the study.
- •11. 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 hormonal contraceptives, surgical intervention, intrauterine
- •device (IUD), and sexual abstinence. 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
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
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 Visit 0 and randomization), defined as requiring acute treatment with inhaled, oral, or intravenous antibiotics prior to the first dose of study drug.
- •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 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 pharmacokinetic 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 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
- •a. Macrolides, e.g., azithromycin or erythromycin
- •b. Inhaled hypertonic saline or inhaled mannitol
- •c. Mucolytics
- •d. Bronchodilator medications
- •e. Oral corticosteroid
- •12. Have had changes in 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 requiring treatment.
- •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 28 days prior
- •to Visit 1.
- •21. 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.
- •22. Have a history or suspicion of unreliability, poor cooperation, or noncompliance
- •with medical treatment.
- •23. Are unable to use nebulizers.
- •24. Are unable either to understand the instructions for use of the study
- •drug or to complete the QoL-B questionnaire at Visit 1.
- •25. Have previously been enrolled in this study.
- •26. 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.
- •27. Have any other condition that, in the opinion of the Investigator,
- •would prohibit the subject from participating in the study.
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