Official Title: “Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Inhaled Ciprofloxacin Compared to Placebo in Subjects With Cystic Fibrosis”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2009

Intervention(s) in this Clinical Trial

• Drug: Ciprofloxacin (Cipro Inhale, Bay q 3939)
  • 32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation powder twice a day for 28 days
• Drug: Placebo
  • 50 mg matching placebo powder formulation twice a day for 28 days
• Drug: Ciprofloxacin (Cipro Inhale, Bay q 3939)
  • 48,75 mg ciprofloxacin betaine corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation powder twice a day for 28 days (Arm 3 and Arm 4 was introduced after amendment 2)
• Drug: Placebo
  • 75 mg matching placebo powder formulation twice a day for 28 days (Arm 3 and Arm 4 was introduced after amendment 2)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
• Placebo Comparator: Arm 2
• Experimental: Arm 3
• Placebo Comparator: Arm 4

Primary Measures

• To compare the change in FEV1 between Cipro Inhale-treated and placebo-treated subjects after a 4-week treatment period
  • Time Frame: from baseline to Day 28-30
    Safety Issue?: Yes

Secondary Measures

• Change in FEV1
  • Time Frame: Baseline, visits 4, 5, 8 and 9
    Safety Issue?: No
• Change in P. aeruginosa density in the sputum
  • Time Frame: Baseline, visits 4, 5, 7, 8 and 9
    Safety Issue?: No
• Time to first pulmonary exacerbation
  • Time Frame: During the whole study course
    Safety Issue?: No
• Changes in forced vital capacity (FVC) and forced expiratory flow rate (FEF)
  • Time Frame: Baseline, visits 4 ,5 ,7 ,8 and 9
    Safety Issue?: No
• Incidence of ciprofloxacin-resistant P. aeruginosa
  • Time Frame: After 28 days of therapy
    Safety Issue?: Yes
• Differences concerning quality of life
  • Time Frame: Visits 7 and 9
    Safety Issue?: No
• The safety profile
  • Time Frame: During the whole study course
    Safety Issue?: Yes
• Occurrence of drug-induced bronchospasm
  • Time Frame: At every visit
    Safety Issue?: Yes
• Plasma and sputum concentrations of ciprofloxacin from selected patients
  • Time Frame: Visits 3, 4, 5 and 7
    Safety Issue?: No

Inclusion Criteria:

• 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 </=80% (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.

Exclusion Criteria:

• Findings on screening history and physical examination unrelated to CF that could potentially affect the efficacy measurements (eg, chest surgery)
• Subjects with colonization of P. 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Overall Contact: Bayer Clinical Trials Contact  clinical-trials-contact@bayerhealthcare.com

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00645788

Study ID Number: 12429

ClinicalTrials.gov Identifier: NCT00645788

Health Authority: United States: Food and Drug Administration

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