Study to Evaluate the Safety and Efficacy of Ciprofloxacin (Inhaled) in Patients With Cystic Fibrosis

Condition(s) targeted: Cystic Fibrosis

Intervention: Ciprofloxacin (Cipro Inhale, Bay q 3939) (Drug); Placebo (Drug); Ciprofloxacin (Cipro Inhale, Bay q 3939) (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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.

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

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: To compare the change in FEV1 (Forced Expiratory Volume in 1 second) between Cipro Inhale-treated and placebo-treated subjects after a 4-week treatment period

Secondary outcome:

Change in FEV1

Change in P. aeruginosa density in the sputum

Time to first pulmonary exacerbation

Changes in forced vital capacity (FVC) and forced expiratory flow rate (FEF)

Incidence of ciprofloxacin-resistant P. aeruginosa

Differences concerning quality of life

The safety profile

Occurrence of drug-induced bronchospasm

Plasma and sputum concentrations of ciprofloxacin from selected patients

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 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

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Copenhagen 2100, Denmark; Recruiting

Berlin 12200, Germany; Recruiting

Haifa, Israel; Not yet recruiting

Haifa, Israel; Recruiting

Jerusalem, Israel; Recruiting

Petach Tikva, Israel; Not yet recruiting

Petach Tikva, Israel; Recruiting

Tel Hashomer, Israel; Recruiting

Oslo 0407, Norway; Terminated

Göteborg 416 85, Sweden; Recruiting

Lund 221 85, Sweden; Recruiting

Uppsala 751 85, Sweden; Recruiting

Phoenix, Arizona 85016, United States; Recruiting

Tucson, Arizona 85724, United States; Recruiting

Little Rock, Arkansas 72205, United States; Recruiting

München, Bayern 80336, Germany; Recruiting

Los Angeles, California 90027, United States; Not yet recruiting

Los Angeles, California 90033, United States; Recruiting

Orange, California 92868, United States; Not yet recruiting

San Francisco, California 94143, United States; Recruiting

Ventura, California 93003, United States; Recruiting

Cambridge, Cambridgeshire CB3 8RE, United Kingdom; Not yet recruiting

Aurora, Colorado 80045, United States; Not yet recruiting

Hartford, Connecticut 06102, United States; Not yet recruiting

New Haven, Connecticut 06520, United States; Recruiting

Jacksonville, Florida 32207, United States; Recruiting

Miami, Florida 33136, United States; Recruiting

Orlando, Florida 32801, United States; Recruiting

Orlando, Florida 32803, United States; Recruiting

Orlando, Florida 32806, United States; Recruiting

Augusta, Georgia 30912-4005, United States; Recruiting

Southampton, Hampshire SO16 6YD, United Kingdom; Recruiting

Frankfurt, Hessen 60590, Germany; Recruiting

Frankfurt, Hessen 60590, Germany; Not yet recruiting

Chicago, Illinois 60614, United States; Recruiting

Chicago, Illinois 60612, United States; Recruiting

Glenview, Illinois 60025, United States; Recruiting

Maywood, Illinois 60153, 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

Ann Arbor, Michigan 48109, United States; Recruiting

Kalamazoo, Michigan 49007, United States; Recruiting

Jackson, Mississippi 39216, United States; Recruiting

Las Vegas, Nevada 89107, United States; Recruiting

Livingston, New Jersey 07039, United States; Recruiting

Long Branch, New Jersey 07740, United States; Recruiting

Morristown, New Jersey 07962, United States; Recruiting

Somerville, New Jersey 08876, United States; Recruiting

Albany, New York 12208, United States; Recruiting

New Hyde Park, New York 11040, United States; Recruiting

St. John's, Newfoundland and Labrador A1B 3V6, Canada; 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

Cincinnati, Ohio 45229-3039, United States; Recruiting

Toledo, Ohio 43606, United States; Recruiting

Oklahoma City, Oklahoma 73112, United States; Recruiting

Oklahoma City, Oklahoma 73104, United States; Recruiting

Hamilton, Ontario L8S 4J9, Canada; Recruiting

London, Ontario N6A 5B8, 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 4029, Australia; Terminated

Chermside, Queensland 4032, Australia; Recruiting

South Brisbane, Queensland 4101, Australia; Recruiting

Leipzig, Sachsen 04103, Germany; Not yet recruiting

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; Recruiting

Charlottesville, Virginia 20908, United States; Recruiting

Seattle, Washington 98105, United States; Recruiting

Birmingham, West Midlands B9 5SS, United Kingdom; Not yet recruiting

Nedlands, Western Australia 6009, Australia; Recruiting

Madison, Wisconsin 53792, United States; Recruiting

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Click here to find results for studies related to marketed products.

Starting date: May 2008
Last updated: October 4, 2010