Trial Condition(s):
Cystic Fibrosis
Study to Evaluate the Safety and Efficacy of Ciprofloxacin (Inhaled) in Patients With Cystic Fibrosis
Bayer Identifier:
12429
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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 </=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
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 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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Klinikum Innenstadt der Ludwigs-Maximilians-Universität München, Germany, 80336 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Birmingham Heartlands Hospital Birmingham, United Kingdom, B9 5SS | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Morristown Memorial Hospital Morristown, United States, 07962 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical University of South Carolina Charleston, United States, 29425 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jasper Clinic Kalamazoo, United States, 49007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Louisville Pulmonary Care Louisville, United States, 40207 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Akron Children's Hospital Akron, United States, 44308-1062 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Children's Memorial Hospital Chicago, United States, 60614 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Monmouth Medical Center Long Branch, United States, 07740 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Children's Hospital of Los Angeles Los Angeles, United States, 90027 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Children's Hospital of Orange County Orange, United States, 92868 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Georgia Health Sciences University Augusta, United States, 30912-4005 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Toledo Children's Hospital Toledo, United States, 43606 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of California, San Francisco San Francisco, United States, 94143 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Johann Wolfgang Goethe Universität Frankfurt Frankfurt, Germany, 60590 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Charité Campus Benjamin Franklin Berlin, Germany, 12200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Johann Wolfgang Goethe Universität Frankfurt Frankfurt, Germany, 60590 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Belfast City Hospital Belfast, United Kingdom, BT12 7AB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Papworth Hospital Cambridge, United Kingdom, CB3 8RE | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southampton General Hospital Southampton, United Kingdom, SO16 6YD | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Alamo Clinical Research Associates San Antonio, United States, 78212 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Utah Medical Center Salt Lake City, United States, 84132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Wisconsin - Madison Madison, United States, 53792 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Children's Lung Specialists, Ltd. Las Vegas, United States, 89107 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Santiago Reyes, MD Oklahoma City, United States, 73112 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pediatric Pulmonary & Asthma Institute Somerville, United States, 08876 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Loyola University Medical Center Maywood, United States, 60153 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ventura County Medical Center Ventura, United States, 93003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tufts-New England Medical Center Boston, United States, 02111 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Albany Medical College Albany, United States, 12208 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Virginia Health System Charlottesville, United States, 22908 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Arkansas for Medical Sciences Little Rock, United States, 72205 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Miami School of Medicine Miami, United States, 33136 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Southern California Los Angeles, United States, 90033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rush University Medical Center Chicago, United States, 60612 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Arizona Medical Center Tucson, United States, 85724 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Michigan Health System Ann Arbor, United States, 48109 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cincinnati Children's Hospital Medical Center Cincinnati, United States, 45229-3039 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Penn Presbyterian Medical Center Philadelphia, United States, 19104-4283 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Duke University Medical Center Durham, United States, 27710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Riley Hospital for Children Indianapolis, United States, 46202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Saint Barnabas Medical Center Livingston, United States, 07039 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Long Island Jewish Medical Center New Hyde Park, United States, 11040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nemours Children's Clinic - Jacksonville Jacksonville, United States, 32207 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hartford Hospital Hartford, United States, 06102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Penn State Milton S. Hershey Medical Center Hershey, United States, 17033-0850 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations OU Children's Physicians Oklahoma City, United States, 73104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Mississippi Medical Center Jackson, United States, 39216 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Phoenix Children's Hospital Phoenix, United States, 85016 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Children's Hospital and Regional Medical Center Seattle, United States, 98105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Children's Hospital Boston Boston, United States, 02115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nemour's Children's Clinic - Orlando Orlando, United States, 32801 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Indiana University Indianapolis, United States, 46202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Janeway Children’s Health and Rehabilitation Centre St. John's, Canada, A1B 3V6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations McMaster University Health Science Centre Hamilton, Canada, L8S 4J9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Skånes Universitetssjukhus Lund, Sweden, 221 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oslo Universitetssykehus HF, Ullevål Oslo, Norway, 0407 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lady Davis Carmel Medical Center Haifa, Israel | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Brian Lyttle, MD London, Canada, N6A 5B8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Montreal Chest Institute Montreal, Canada, H2X 2P4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Akademiska barnsjukhuset Uppsala, Sweden, 751 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SU/Östra Göteborg, Sweden, 416 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations H:S Rigshospitalet Copenhagen, Denmark, 2100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chaim Sheba Medical Center Tel Hashomer, Israel | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hadassah University Hospital Mount Scopus Jerusalem, Israel | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rabin Medical Center - Beilinson Campus Petach Tikva, Israel | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Brisbane Mater Misericordiae Hospital South Brisbane, Australia, 4101 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Prince Charles Hospital Chermside, Australia, 4032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Schneider Children's Medical Center Petach Tikva, Israel | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rambam Medical Center Haifa, Israel | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sir Charles Gairdner Hospital Nedlands, Australia, 6009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Adelaide Hospital Adelaide, Australia, 5000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Children's Hospital Melbourne Parkville, Australia, 3052 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Children's Hospital Brisbane Brisbane, Australia, 4029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Central Florida Pulmonary Group, PA Orlando, United States, 32803 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yale University School of Medicine New Haven, United States, 06520 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Arnold Palmer Hospital for Children Orlando, United States, 32806 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations East Tennessee Children's Hospital Knoxville, United States, 37916 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Iowa city, United States, 52242-1089 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Christopher's Hospital for Children Philadelphia, United States, 19134 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valhalla, United States, 10595 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tulsa, United States, 74145 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Children's Asthma Respiratory & Exercise Specialists Glenview, United States, 60025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rady Children's Hospital–San Diego San Diego, United States, 92123-4282 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kentucky Clinic Lexington, United States, 40536-0284 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Children's Hospital Aurora, United States, 80045 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Austin Children's Chest Associates Austin, United States, 78723 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Leipzig AöR Leipzig, Germany, 04103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southern California Institute for Respiratory Diseases, Inc. Los Angeles, United States, 90048 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Monash Medical Centre Clayton, Australia, 3168 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
4
Primary Outcome
- Change from baseline in Forced expiratory volume in 1 second (FEV1) at Day 28‑30Timeframe: Baseline and End of treatment (Day 28-30)
Secondary Outcome
- Change from baseline in FEV1 at Visits 4, 5, and Follow-up Visits 8 and 9Timeframe: 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 9Timeframe: 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).
- Time to first pulmonary exacerbations requiring interventionTimeframe: Up to visit 9 (Day 56-60)
- Change from baseline in forced vital capacity (FVC) at visits 4, 5, 7, 8 and 9Timeframe: 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 9Timeframe: 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 isolatesTimeframe: Baseline and up to visit 9 (day 56-60)
- Number of participants developing ciprofloxacin-resistant non-mucoid P.aeruginosa isolatesTimeframe: Baseline and up to 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 scaleTimeframe: Baseline and Visit 7 (Day 28-30) and Visit 9 (Day 56 -60)
- Plasma concentrations of ciprofloxacin from selected participants during treatmentTimeframe: Up to visit 7 (Day 28-30)
- Sputum concentrations of ciprofloxacin from selected participants during treatmentTimeframe: Up to visit 7 (Day 28-30
- Number of participants with occurrence of drug induced BronchospasmsTimeframe: Up to visit 9 (Day 56-60)
Additional Information
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