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
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
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Copenhagen DK-2100, Denmark; Recruiting
Berlin 12200, Germany; Not yet recruiting
Tel Hashomer 52621, Israel; Not yet recruiting
Jerusalem 91240, Israel; Recruiting
Haifa 34362, Israel; Not yet recruiting
Petach Tikva 49202, Israel; Recruiting
Petach Tikva 49100, Israel; Not yet recruiting
Haifa 31096, Israel; Recruiting
Oslo 0407, Norway; Not yet recruiting
Uppsala 751 85, Sweden; Not yet recruiting
Lund 221 85, Sweden; Not yet recruiting
Göteborg 416 85, Sweden; Recruiting
Phoenix, Arizona 85016, United States; Not yet recruiting
Tucson, Arizona 85724, United States; Recruiting
Little Rock, Arkansas 72205, United States; Recruiting
Los Angeles, California 90027-6089, United States; Not yet recruiting
Orange, California 92868-3974, United States; Not yet recruiting
San Francisco, California 94117, United States; Recruiting
Ventura, California 93003, United States; Recruiting
Los Angeles, California 90089, United States; Recruiting
Cambridge, Cambridgeshire CB3 8RE, United Kingdom; Not yet recruiting
Hartford, Connecticut 06102-5037, United States; Not yet recruiting
Jacksonville, Florida 32207, United States; Recruiting
Miami, Florida 33136, United States; Recruiting
Orlando, Florida 32806, United States; Recruiting
Augusta, Georgia 30912, United States; Recruiting
Southampton, Hampshire SO16 6YD, United Kingdom; Not yet recruiting
Frankfurt, Hessen 60596, Germany; Not yet recruiting
Chicago, Illinois 60614, United States; Recruiting
Maywood, Illinois 60153, United States; Recruiting
Chicago, Illinois 60612, United States; Recruiting
Indianapolis, Indiana 46202, United States; Recruiting
Louisville, Kentucky 40207, United States; Recruiting
Boston, Massachusetts 02111, United States; Recruiting
Boston, Massachusetts 02115, United States; Recruiting
Kalamazoo, Michigan 49007, United States; Recruiting
Ann Arbor, Michigan 48109-0330, United States; Recruiting
Jackson, Mississippi 39216, United States; Recruiting
Las Vegas, Nevada 89107, United States; Recruiting
Morristown, New Jersey 07962-1956, United States; Recruiting
Somerville, New Jersey 08876, United States; Recruiting
Long Branch, New Jersey 07740, United States; Recruiting
Livingston, New Jersey 07039, United States; Recruiting
Albany, New York 12208, United States; Recruiting
St. John's, Newfoundland and Labrador A1B 3V6, Canada; Not yet recruiting
Durham, North Carolina 27710, United States; Recruiting
Belfast, Northern Ireland BT12 7AB, United Kingdom; Not yet recruiting
Akron, Ohio 44308-1062, United States; Recruiting
Toledo, Ohio 43606, United States; Recruiting
Cincinnati, Ohio 45229-3039, United States; Recruiting
Oklahoma City, Oklahoma 73112, United States; Recruiting
Oklahoma City, Oklahoma 73104, United States; Recruiting
London, Ontario N6A 5B8, Canada; Recruiting
Hamilton, Ontario L8S 4J9, Canada; Recruiting
Hershey, Pennsylvania 17033-0850, United States; Recruiting
Philadelphia, Pennsylvania 19104-4283, United States; Recruiting
Montreal, Quebec H2X 2P4, Canada; Not yet recruiting
Brisbane, Queensland 4101, Australia; Recruiting
Chermside, Queensland 4032, Australia; Not yet recruiting
Brisbane, Queensland 4029, Australia; Terminated
Adelaide, South Australia 5000, Australia; Recruiting
Charleston, South Carolina 29425, United States; Recruiting
San Antonio, Texas 78212, United States; Recruiting
Salt Lake City, Utah 84132, United States; Recruiting
Parkville, Victoria 3052, Australia; Not yet recruiting
Charlottesville, Virginia 20908, United States; Recruiting
Seattle, Washington 98105, United States; Not yet recruiting
Birmingham, West Midlands B9 5SS, United Kingdom; Not yet recruiting
Nedlands, Western Australia 6009, Australia; Recruiting
Madison, Wisconsin 53792, United States; Recruiting
