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:

NCT00645788

EudraCT Number:

2008-008314-40

EU CT Number:

Not Available

Study Completed

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
288
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Ciprofloxacin DPI (BAYQ3939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
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Klinikum Innenstadt der Ludwigs-Maximilians-Universität

München, Germany, 80336

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Birmingham Heartlands Hospital

Birmingham, United Kingdom, B9 5SS

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Morristown Memorial Hospital

Morristown, United States, 07962

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Medical University of South Carolina

Charleston, United States, 29425

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Jasper Clinic

Kalamazoo, United States, 49007

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Louisville Pulmonary Care

Louisville, United States, 40207

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Akron Children's Hospital

Akron, United States, 44308-1062

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Children's Memorial Hospital

Chicago, United States, 60614

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Monmouth Medical Center

Long Branch, United States, 07740

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Children's Hospital of Los Angeles

Los Angeles, United States, 90027

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Children's Hospital of Orange County

Orange, United States, 92868

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Georgia Health Sciences University

Augusta, United States, 30912-4005

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Toledo Children's Hospital

Toledo, United States, 43606

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University of California, San Francisco

San Francisco, United States, 94143

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Klinikum der Johann Wolfgang Goethe Universität Frankfurt

Frankfurt, Germany, 60590

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Charité Campus Benjamin Franklin

Berlin, Germany, 12200

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Klinikum der Johann Wolfgang Goethe Universität Frankfurt

Frankfurt, Germany, 60590

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Belfast City Hospital

Belfast, United Kingdom, BT12 7AB

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Papworth Hospital

Cambridge, United Kingdom, CB3 8RE

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Southampton General Hospital

Southampton, United Kingdom, SO16 6YD

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Alamo Clinical Research Associates

San Antonio, United States, 78212

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University of Utah Medical Center

Salt Lake City, United States, 84132

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University of Wisconsin - Madison

Madison, United States, 53792

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Children's Lung Specialists, Ltd.

Las Vegas, United States, 89107

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Office of Dr. Santiago Reyes, MD

Oklahoma City, United States, 73112

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Pediatric Pulmonary & Asthma Institute

Somerville, United States, 08876

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Loyola University Medical Center

Maywood, United States, 60153

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Ventura County Medical Center

Ventura, United States, 93003

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Tufts-New England Medical Center

Boston, United States, 02111

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Albany Medical College

Albany, United States, 12208

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University of Virginia Health System

Charlottesville, United States, 22908

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University of Arkansas for Medical Sciences

Little Rock, United States, 72205

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University of Miami School of Medicine

Miami, United States, 33136

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University of Southern California

Los Angeles, United States, 90033

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Rush University Medical Center

Chicago, United States, 60612

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University of Arizona Medical Center

Tucson, United States, 85724

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University of Michigan Health System

Ann Arbor, United States, 48109

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Cincinnati Children's Hospital Medical Center

Cincinnati, United States, 45229-3039

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Penn Presbyterian Medical Center

Philadelphia, United States, 19104-4283

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Duke University Medical Center

Durham, United States, 27710

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Riley Hospital for Children

Indianapolis, United States, 46202

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Saint Barnabas Medical Center

Livingston, United States, 07039

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Long Island Jewish Medical Center

New Hyde Park, United States, 11040

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Nemours Children's Clinic - Jacksonville

Jacksonville, United States, 32207

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Hartford Hospital

Hartford, United States, 06102

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Penn State Milton S. Hershey Medical Center

Hershey, United States, 17033-0850

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OU Children's Physicians

Oklahoma City, United States, 73104

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University of Mississippi Medical Center

Jackson, United States, 39216

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Phoenix Children's Hospital

Phoenix, United States, 85016

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Children's Hospital and Regional Medical Center

Seattle, United States, 98105

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Children's Hospital Boston

Boston, United States, 02115

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Nemour's Children's Clinic - Orlando

Orlando, United States, 32801

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Indiana University

Indianapolis, United States, 46202

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Janeway Children’s Health and Rehabilitation Centre

St. John's, Canada, A1B 3V6

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McMaster University Health Science Centre

Hamilton, Canada, L8S 4J9

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Skånes Universitetssjukhus

Lund, Sweden, 221 85

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Oslo Universitetssykehus HF, Ullevål

Oslo, Norway, 0407

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Lady Davis Carmel Medical Center

Haifa, Israel

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Office of Dr. Brian Lyttle, MD

London, Canada, N6A 5B8

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Montreal Chest Institute

Montreal, Canada, H2X 2P4

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Akademiska barnsjukhuset

Uppsala, Sweden, 751 85

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SU/Östra

Göteborg, Sweden, 416 85

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H:S Rigshospitalet

Copenhagen, Denmark, 2100

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Chaim Sheba Medical Center

Tel Hashomer, Israel

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Hadassah University Hospital Mount Scopus

Jerusalem, Israel

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Rabin Medical Center - Beilinson Campus

Petach Tikva, Israel

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Brisbane Mater Misericordiae Hospital

South Brisbane, Australia, 4101

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The Prince Charles Hospital

Chermside, Australia, 4032

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Schneider Children's Medical Center

Petach Tikva, Israel

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Rambam Medical Center

Haifa, Israel

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Sir Charles Gairdner Hospital

Nedlands, Australia, 6009

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Royal Adelaide Hospital

Adelaide, Australia, 5000

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Royal Children's Hospital Melbourne

Parkville, Australia, 3052

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Royal Children's Hospital Brisbane

Brisbane, Australia, 4029

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Central Florida Pulmonary Group, PA

Orlando, United States, 32803

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Yale University School of Medicine

New Haven, United States, 06520

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Arnold Palmer Hospital for Children

Orlando, United States, 32806

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East Tennessee Children's Hospital

Knoxville, United States, 37916

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Investigative Site

Iowa city, United States, 52242-1089

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St. Christopher's Hospital for Children

Philadelphia, United States, 19134

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Investigative Site

Valhalla, United States, 10595

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Investigative Site

Tulsa, United States, 74145

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Children's Asthma Respiratory & Exercise Specialists

Glenview, United States, 60025

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Rady Children's Hospital–San Diego

San Diego, United States, 92123-4282

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Kentucky Clinic

Lexington, United States, 40536-0284

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The Children's Hospital

Aurora, United States, 80045

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Austin Children's Chest Associates

Austin, United States, 78723

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Universitätsklinikum Leipzig AöR

Leipzig, Germany, 04103

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Southern California Institute for Respiratory Diseases, Inc.

Los Angeles, United States, 90048

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Monash Medical Centre

Clayton, Australia, 3168

Trial Design