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.
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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
Copenhagen 2100, Denmark
Berlin 12200, Germany
Haifa, Israel
Jerusalem, Israel
Petach Tikva, Israel
Tel Hashomer, Israel
Oslo 0407, Norway
Göteborg 416 85, Sweden
Lund 221 85, Sweden
Uppsala 751 85, Sweden
Phoenix, Arizona 85016, United States
Tucson, Arizona 85724, United States
Little Rock, Arkansas 72205, United States
München, Bayern 80336, Germany
Los Angeles, California 90048, United States
Los Angeles, California 90033, United States
Los Angeles, California 90027, United States
Orange, California 92868, United States
San Diego, California 92123-4282, United States
San Francisco, California 94143, United States
Ventura, California 93003, United States
Cambridge, Cambridgeshire CB3 8RE, United Kingdom
Aurora, Colorado 80045, United States
Hartford, Connecticut 06102, United States
New Haven, Connecticut 06520, United States
Jacksonville, Florida 32207, United States
Miami, Florida 33136, United States
Orlando, Florida 32803, United States
Orlando, Florida 32806, United States
Orlando, Florida 32801, United States
Augusta, Georgia 30912-4005, United States
Southampton, Hampshire SO16 6YD, United Kingdom
Frankfurt, Hessen 60590, Germany
Chicago, Illinois 60612, United States
Chicago, Illinois 60614, United States
Glenview, Illinois 60025, United States
Maywood, Illinois 60153, United States
Indianapolis, Indiana 46202, United States
Iowa city, Iowa 52242-1089, United States
Lexington, Kentucky 40536-0284, United States
Louisville, Kentucky 40207, United States
Boston, Massachusetts 02111, United States
Boston, Massachusetts 02115, United States
Ann Arbor, Michigan 48109, United States
Kalamazoo, Michigan 49007, United States
Jackson, Mississippi 39216, United States
Las Vegas, Nevada 89107, United States
Livingston, New Jersey 07039, United States
Long Branch, New Jersey 07740, United States
Morristown, New Jersey 07962, United States
Somerville, New Jersey 08876, United States
Albany, New York 12208, United States
New Hyde Park, New York 11040, United States
Valhalla, New York 10595, United States
St. John's, Newfoundland and Labrador A1B 3V6, Canada
Durham, North Carolina 27710, United States
Belfast, North Ireland BT12 7AB, United Kingdom
Akron, Ohio 44308-1062, United States
Cincinnati, Ohio 45229-3039, United States
Toledo, Ohio 43606, United States
Oklahoma City, Oklahoma 73104, United States
Oklahoma City, Oklahoma 73112, United States
Tulsa, Oklahoma 74145, United States
Hamilton, Ontario L8S 4J9, Canada
London, Ontario N6A 5B8, Canada
Hershey, Pennsylvania 17033-0850, United States
Philadelphia, Pennsylvania 19104-4283, United States
Philadelphia, Pennsylvania 19134, United States
Montreal, Quebec H2X 2P4, Canada
Brisbane, Queensland 4029, Australia
Chermside, Queensland 4032, Australia
South Brisbane, Queensland 4101, Australia
Leipzig, Sachsen 04103, Germany
Adelaide, South Australia 5000, Australia
Charleston, South Carolina 29425, United States
Knoxville, Tennessee 37916, United States
Austin, Texas 78723, United States
San Antonio, Texas 78212, United States
Salt Lake City, Utah 84132, United States
Clayton, Victoria 3168, Australia
Parkville, Victoria 3052, Australia
Charlottesville, Virginia 22908, United States
Seattle, Washington 98105, United States
Birmingham, West Midlands B9 5SS, United Kingdom
Nedlands, Western Australia 6009, Australia
Madison, Wisconsin 53792, United States