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...
Date First Received: March 26, 2008
Last Updated: June 30, 2009
Verified by: Bayer, June 2009
Clinical Trial Phase: Phase 2 | Start Date: May 2008
Overall Status: Recruiting
Estimated Enrollment: 210
Brief Summary
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”
Condition Keyword(s):
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
Outcome Measures for this Clinical Trial
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
- Time Frame: from baseline to Day 28-30
Secondary Measures
- Change in FEV1
- Time Frame: Baseline, visits 4, 5, 8 and 9
Safety Issue?: No
- Time Frame: Baseline, visits 4, 5, 8 and 9
- Change in P. aeruginosa density in the sputum
- Time Frame: Baseline, visits 4, 5, 7, 8 and 9
Safety Issue?: No
- Time Frame: Baseline, visits 4, 5, 7, 8 and 9
- Time to first pulmonary exacerbation
- Time Frame: During the whole study course
Safety Issue?: No
- Time Frame: During the whole study course
- 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
- Time Frame: Baseline, visits 4 ,5 ,7 ,8 and 9
- Incidence of ciprofloxacin-resistant P. aeruginosa
- Time Frame: After 28 days of therapy
Safety Issue?: Yes
- Time Frame: After 28 days of therapy
- Differences concerning quality of life
- Time Frame: Visits 7 and 9
Safety Issue?: No
- Time Frame: Visits 7 and 9
- The safety profile
- Time Frame: During the whole study course
Safety Issue?: Yes
- Time Frame: During the whole study course
- Occurrence of drug-induced bronchospasm
- Time Frame: At every visit
Safety Issue?: Yes
- Time Frame: At every visit
- Plasma and sputum concentrations of ciprofloxacin from selected patients
- Time Frame: Visits 3, 4, 5 and 7
Safety Issue?: No
- Time Frame: Visits 3, 4, 5 and 7
Criteria for Participation in this Clinical Trial
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
Clinical Trial Sponsor Information
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
Additional Information
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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