NCT00645788已完成2 期
Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Inhaled Ciprofloxacin Compared to Placebo in Subjects With Cystic Fibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 288
- 主要终点
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Day 28-30
研究概览
简要总结
To evaluate the change in forced expiratory volume (FEV1) from baseline to Day 28-30 between Cipro Inhale-treated and placebo-treated subjects after a 4-week treatment period.
详细描述
Safety issues are addressed in the Adverse Events section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects, or their legal representative(s), must have given their written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures
- •Children (12 - 17 years) or adults >/=18 years
- •Documented diagnosis Cystic Fibrosis (CF):
- •documented sweat chloride >/=60 mEq/L by quantitative pilocarpine iontophoresis test (QPIT) or nasal potential difference
- •either homozygous for ΔF508 genetic mutation or a compound heterozygous for 2 known CF mutations
- •and clinical findings consistent with CF
- •Chronic colonization with P. aeruginosa defined as a positive respiratory tract culture (sputum or throat swab) within 12 months prior to screening and at screening (Note: subjects with negative culture at screening can, at the discretion of the investigator, be rescreened at a later date)
- •Ability to perform reproducible pulmonary function tests
- •Ability to produce sputum (noninduced)
- •Stable pulmonary status, FEV1 >/=35% to </=75% (intraindividual variability +/-10% of absolute value). Note: The subject is not eligible for enrollment if the variability results in (or leads to) an FEV1 <35%.
- •Room air oximetry >/=88% saturation
- •Off antibiotics (except macrolide) and Cipro (oral) for at least 30 days prior to the administration of study drug for pulmonary exacerbation
- •Stable regimen of standard CF treatment including chest physiotherapies and exercise regimens should not change during the 30 days prior to the administration of study drug and during the study (including macrolide administration unchanged in the previous 30 days)
- •Subjects who are able to understand and follow instructions and who are able to participate in the study for the entire period
- •Women who are willing to use an adequate method of contraception for 3 months after receiving the study drug. Adequate methods of contraception include vasectomy or condom use by their partners, diaphragm with spermicidal gel, coil (intrauterine device), surgical sterilization or oral contraceptive
排除标准
- •Findings on screening history and physical examination unrelated to CF that could potentially affect the efficacy measurements (eg, chest surgery)
- •Subjects with colonization of Pseudomonas aeruginosa and a CIPRO MIC of >/=256 µg/ml or mg/l
- •Burkholderia cepacia complex colonization of their respiratory tract within the past 12 months (documented by screen laboratory)
- •Known aspergillosis (unless asymptomatic). Patients with invasive disease, ABPA with IGE > 500 mg/dL will be excluded
- •Transaminase level >3x upper limit of normal (ULN)
- •Massive hemoptysis (>/=300 cc or requiring blood transfusion) in the preceding 4 weeks
- •Intravenous antibiotic treatment for pulmonary exacerbation in the past 30 days
- •Subjects with a medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor
- •Febrile illness within 1 week before the start of the study
- •Active treatment for nontuberculosis mycobacteria
- •Exposure to any investigational drug within 30 days
- •Any history of allergic reaction to fluoroquinolones or other quinolones
- •On oral steroids >20 mg/day for longer than 14 days in the past 3 months
- •Creatinine >/=2x ULN
研究组 & 干预措施
32.50 mg Ciprofloxacin DPI (BAYQ3939)
Experimental
32.50 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
干预措施: Ciprofloxacin (Cipro Inhale, BAYQ3939) (Drug)
48.75 mg Ciprofloxacin DPI (BAYQ3939)
Experimental
48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
干预措施: Ciprofloxacin (Cipro Inhale, BAYQ3939) (Drug)
Matching Placebo for 32.50 mg
Placebo Comparator
Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
干预措施: Placebo (Drug)
Matching Placebo for 48.75 mg
Placebo Comparator
Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Day 28-30
时间窗: Baseline and End of treatment (Day 28-30)
FEV1: The maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS). This was recorded at the site using a spirometer. The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.
次要结局
- Number of Participants With the Occurrence of Drug Induced Bronchospasms(Up to visit 9 (Day 56-60))
- Change From Baseline in FEV1 at Visits 4, 5, and Follow-up Visits 8 and 9(Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).)
- Change From Baseline in P. Aeruginosa Density in the Sputum at Visits 4, 5, 7, 8 and 9(Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).)
- Effect of Ciprofloxacin DPI Treatment on Quality of Life Measured by Cystic Fibrosis Quality of Life Questionnaire Revised (CFQ-R), Respiratory Scale(Baseline and Visit 7 (Day 28-30) and Visit 9 (Day 56 -60))
- Plasma Concentrations of Ciprofloxacin From Selected Participants During Treatment(Up to visit 7 (Day 28-30))
- Sputum Concentrations of Ciprofloxacin From Selected Participants During Treatment(Up to visit 7 (Day 28-30))
- Time to First Pulmonary Exacerbation Requiring Intervention(Up to visit 9 (Day 56-60))
- Change From Baseline in Forced Vital Capacity (FVC) at Visits 4, 5, 7, 8 and 9(Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).)
- Change From Baseline in Forced Expiratory Flow (FEF 25-75%) at Visits 4, 5, 7, 8 and 9(Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).)
- Number of Participants Developing Ciprofloxacin-resistant Mucoid P.Aeruginosa Isolates(Baseline and up to visit 9 (day 56-60))
- Number of Participants Developing Ciprofloxacin-resistant Non-mucoid P.Aeruginosa Isolates(Baseline and up to visit 9 (day 56-60))
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