EUCTR2010-019634-26-DE进行中（未招募）不适用
A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution (TIS) in Stable Cystic Fibrosis Patients
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 330
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
- •Patients will be included in the study if they meet all of the following criteria:
- •1. Are at least 18 years of age
- •2. Weigh at least 30 kilograms (kg) or 66 pounds
- •3. Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
- •a) sweat chloride > 60 mEq/liter by quantitative pilocarpine iontophoresis test (QPIT)
- •b) two well-characterized mutations in the cystic fibrosis transmembrane conductive regulator (CFTR) gene
- •c) abnormal nasal potential difference
- •4. Are able to elicit an FEV1 > 25% but < 85% predicted value at screening based on
- •Hankinson/NHanes III criteria
- •5. Must have a sputum or throat swab (if unable to produce sputum) specimen at screening positive for P. aeruginosa and have a history of at least one additional sputum culture positive for P. aeruginosa within the last 12 months prior to Visit 1
- •6. Must have received at least three 28 day courses or a total of 84 days of an inhaled tobramycin over the previous 12 months, with at least a minimum 14 day course being finished within 29-56 days prior to Visit 1
- •7. Clinically stable with no significant changes in health status within the last 28 days prior to Visit 1
- •8. Are able to perform an acceptable spirometry session (defined as 3 acceptable or usable efforts per ATS/ERS criteria at Screening
- •9. Have not smoked tobacco within 28 days prior to Visit 1 and agree not to smoke for the duration of the study
- •10. Are able to and have given written informed consent (if they are adults) or assent in combination with consent of their legal representative(s) (if they are minors) in a manner approved by the Institutional Review Board/Ethics Committee, and are willing to comply with the requirements of the study
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Patients will be excluded from the study if they meet any of the following criteria:
- •1. Have used an investigational agent within 28 days prior to Visit 1
- •2. Have used any nebulized or systemic antimicrobials active against P. aeruginosa within 28 days prior to Visit 1, other than maintenance oral azithromycin, which must have been initiated at least 28 days prior to Visit 1
- •3. History of hypersensitivity or intolerance to fluoroquinolones (e.g. joint or tendon disorders), or any excipients of MP-376 (magnesium chloride)
- •4. History of hypersensitivity or intolerance to inhaled or systemic aminoglycosides, including tobramycin or any excipients of TIS (sodium chloride, sulfuric acid, sodium hydroxide)
- •5. History of intolerance to bronchodilators or unwilling to use a bronchodilator during the study
- •6. Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone/day or 20 mg prednisone every other day at Screening or Visit 1
- •7. Changes in technique or schedule of physiotherapy and/or airway clearance techniques (ACT) within 14 days to Visit 1
- •8. Changes in medical regimen for treatment of CF (e.g., introduction, dose escalation, or elimination of therapies such as dornase alfa, non-steroidal anti-inflammatory agents, azithromycin, hypertonic saline, or inhaled corticosteroids) within 28 days of Visit 1
- •9. History of lung transplantation
- •10. Evidence of acute upper respiratory tract infection within 10 days or lower respiratory tract infection within 28 days prior to Visit 1
- •11. Active treatment for allergic bronchopulmonary aspergillosis (ABPA)
- •12. Active treatment for mycobacterial lung infection
- •13. Are pregnant, breastfeeding, or unwilling to practice a highly effective method of birth control or abstinence during participation in the study (women only).
- •14. Have a history of seizure disorder requiring anti-seizure medications (e.g., epilepsy)
- •15. Known history of chronic infection with human immunodeficiency virus (HIV), or chronic active hepatitis secondary to hepatitis B, and/or hepatitis C infection (Based
- •on medical history, screening labs are not required)
- •16. Have a history of hemoptysis > 30 mLs over any 24 hour period during the 28 days prior to Visit 1
- •17. Have a calculated creatinine clearance less than 20mL/min (Cockroft-Gault method) at Screening for patients that are = 18 years of age. Have a calculated creatinine clearance less than 20 mL/min/1.73m2 (Schwarz method) at Screening for patients that are <18 years of age
- •18. Have an oxygen saturation < 90% on room air at Screening or Visit 1
- •19. Have a > 15% relative change (increase or decline) in FEV1(L) from Screening to Visit 1
- •20. History of suspected auditory, vestibular, or neuromuscular dysfunction
- •21. Have a present condition, or abnormality in screening laboratory tests or physica
- •examination findings, that in the opinion of the Investigator or Medical Monitor would compromise the safety of the patient or the quality of the data
- •22. Are a dependent (as an employee or relative) of the sponsor, contract research organization, or investigator
研究者
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