Official Title: “Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Ciprofloxacin (Inhaled) Compared to Placebo in Patients With Cystic Fibrosis”

Study to evaluate the safety and efficacy of ciprofloxacin (inhaled) in patients with Cystic Fibrosis

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2009

Intervention(s) in this Clinical Trial

• Drug: Cipro (BAY Q3939)
  • 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

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Arm 2
• Active Comparator: Arm 1

Primary Measures

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

Secondary Measures

• To compare the change in FEV1 from baseline to Visits 4, 5, and Follow-up Visits 8 and 9 between the Cipro Inhale-treated group and the placebo-treated group
  • Time Frame: During Study
    Safety Issue?: Yes
• Assess the change in P aeruginosa density in the sputum from baseline between the Cipro Inhale-treated group and the placebo-treated group at Visits 4, 5, 7, 8 and 9
  • Time Frame: During Study
    Safety Issue?: No
• Determine the time to first pulmonary exacerbation requiring any antipseudomonal intervention or hospitalization occurring in subjects given Cipro Inhale compared to subjects given placebo
  • Time Frame: During Study
    Safety Issue?: Yes
• Assess the change from baseline forced vital capacity (FVC) and forced expiratory flow rate (FEF) 25-75% of the Cipro Inhale-treated group and the placebo-treated group at Visits 4, 5, 7, 8 and 9
  • Time Frame: During Study
    Safety Issue?: No
• Determine the incidence of ciprofloxacin-resistant P aeruginosa isolates in the Cipro Inhale-treated group after 28 days of therapy compared to the placebo-treated group
  • Time Frame: During Study
    Safety Issue?: No
• Determine differences between the Cipro Inhale-treated group and the placebo-treated group concerning quality of life as measured by the CF Quality of Life Questionnaire Revised (CFQ-R) at Visits 7 and 9
  • Time Frame: During Study
    Safety Issue?: No
• Assess the safety profile of subjects given Cipro Inhale compared to placebo
  • Time Frame: During Study
    Safety Issue?: Yes
• Assess the occurrence of drug-induced bronchospasm in subjects given Cipro Inhale compared to placebo
  • Time Frame: During Study
    Safety Issue?: Yes

Inclusion Criteria:

• Subjects must have given their written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures
• Adults greater than or equal to 18 years
• Documented diagnosis of CF:
• documented sweat chloride greater than or equal to 60 mEq/L by quantitative pilocarpine iontophoresis test (QPIT) or
• 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 Greater than or equal to 35% to ≤75%
• Room air oximetry greater than or equal to 88% saturation
• Off antibiotics (except macrolide) and Cipro (oral) for at least 30 days prior to the administration of study drug
• 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 colonization of their respiratory tract within the past 12 months (documented by screen laboratory)
• Known aspergillosis (unless asymptomatic)
• Transaminase level >3x upper limit of normal (ULN)
• Massive hemoptysis (greater than or equal to 300 cc or requiring blood transfusion) in the preceding 4 weeks
• IV 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
• Subjects with a history of severe allergies, nonallergic drug reactions, or multiple drug allergies
• Female subjects who are pregnant, lactating or in whom pregnancy cannot be excluded (Note: a urine pregnancy test will be performed on all women of childbearing potential before inclusion in the study, followed by serum pregnancy test.)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 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 November 20, 2008

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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