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

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
Status
LocationsStatus
Locations

Klinikum Innenstadt der Ludwigs-Maximilians-Universität

München, Germany, 80336

Status
Completed
 
Locations

Birmingham Heartlands Hospital

Birmingham, United Kingdom, B9 5SS

Status
Terminated
 
Locations

Morristown Memorial Hospital

Morristown, United States, 07962

Status
Completed
 
Locations

Medical University of South Carolina

Charleston, United States, 29425

Status
Completed
 
Locations

Jasper Clinic

Kalamazoo, United States, 49007

Status
Completed
 
Locations

Louisville Pulmonary Care

Louisville, United States, 40207

Status
Completed
 
Locations

Akron Children's Hospital

Akron, United States, 44308-1062

Status
Completed
 
Locations

Children's Memorial Hospital

Chicago, United States, 60614

Status
Completed
 
Locations

Monmouth Medical Center

Long Branch, United States, 07740

Status
Completed
 
Locations

Children's Hospital of Los Angeles

Los Angeles, United States, 90027

Status
Terminated
 
Locations

Children's Hospital of Orange County

Orange, United States, 92868

Status
Terminated
 
Locations

Georgia Health Sciences University

Augusta, United States, 30912-4005

Status
Completed
 
Locations

Toledo Children's Hospital

Toledo, United States, 43606

Status
Completed
 
Locations

University of California, San Francisco

San Francisco, United States, 94143

Status
Completed
 
Locations

Klinikum der Johann Wolfgang Goethe Universität Frankfurt

Frankfurt, Germany, 60590

Status
Terminated
 
Locations

Charité Campus Benjamin Franklin

Berlin, Germany, 12200

Status
Completed
 
Locations

Klinikum der Johann Wolfgang Goethe Universität Frankfurt

Frankfurt, Germany, 60590

Status
Completed
 
Locations

Belfast City Hospital

Belfast, United Kingdom, BT12 7AB

Status
Terminated
 
Locations

Papworth Hospital

Cambridge, United Kingdom, CB3 8RE

Status
Terminated
 
Locations

Southampton General Hospital

Southampton, United Kingdom, SO16 6YD

Status
Completed
 
Locations

Alamo Clinical Research Associates

San Antonio, United States, 78212

Status
Completed
 
Locations

University of Utah Medical Center

Salt Lake City, United States, 84132

Status
Completed
 
Locations

University of Wisconsin - Madison

Madison, United States, 53792

Status
Completed
 
Locations

Children's Lung Specialists, Ltd.

Las Vegas, United States, 89107

Status
Completed
 
Locations

Office of Dr. Santiago Reyes, MD

Oklahoma City, United States, 73112

Status
Completed
 
Locations

Pediatric Pulmonary & Asthma Institute

Somerville, United States, 08876

Status
Completed
 
Locations

Loyola University Medical Center

Maywood, United States, 60153

Status
Completed
 
Locations

Ventura County Medical Center

Ventura, United States, 93003

Status
Completed
 
Locations

Tufts-New England Medical Center

Boston, United States, 02111

Status
Completed
 
Locations

Albany Medical College

Albany, United States, 12208

Status
Completed
 
Locations

University of Virginia Health System

Charlottesville, United States, 22908

Status
Completed
 
Locations

University of Arkansas for Medical Sciences

Little Rock, United States, 72205

Status
Completed
 
Locations

University of Miami School of Medicine

Miami, United States, 33136

Status
Completed
 
Locations

University of Southern California

Los Angeles, United States, 90033

Status
Completed
 
Locations

Rush University Medical Center

Chicago, United States, 60612

Status
Completed
 
Locations

University of Arizona Medical Center

Tucson, United States, 85724

Status
Completed
 
Locations

University of Michigan Health System

Ann Arbor, United States, 48109

Status
Completed
 
Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, United States, 45229-3039

Status
Completed
 
Locations

Penn Presbyterian Medical Center

Philadelphia, United States, 19104-4283

Status
Completed
 
Locations

Duke University Medical Center

Durham, United States, 27710

Status
Completed
 
Locations

Riley Hospital for Children

Indianapolis, United States, 46202

Status
Completed
 
Locations

Saint Barnabas Medical Center

Livingston, United States, 07039

Status
Completed
 
Locations

Long Island Jewish Medical Center

New Hyde Park, United States, 11040

Status
Completed
 
Locations

Nemours Children's Clinic - Jacksonville

Jacksonville, United States, 32207

Status
Completed
 
Locations

Hartford Hospital

Hartford, United States, 06102

Status
Terminated
 
Locations

Penn State Milton S. Hershey Medical Center

Hershey, United States, 17033-0850

Status
Completed
 
Locations

OU Children's Physicians

Oklahoma City, United States, 73104

Status
Completed
 
Locations

University of Mississippi Medical Center

Jackson, United States, 39216

Status
Completed
 
Locations

Phoenix Children's Hospital

Phoenix, United States, 85016

Status
Completed
 
Locations

Children's Hospital and Regional Medical Center

Seattle, United States, 98105

Status
Completed
 
Locations

Children's Hospital Boston

Boston, United States, 02115

Status
Completed
 
Locations

Nemour's Children's Clinic - Orlando

Orlando, United States, 32801

Status
Completed
 
Locations

Indiana University

Indianapolis, United States, 46202

Status
Completed
 
Locations

Janeway Children’s Health and Rehabilitation Centre

St. John's, Canada, A1B 3V6

Status
Completed
 
Locations

McMaster University Health Science Centre

Hamilton, Canada, L8S 4J9

Status
Completed
 
Locations

Skånes Universitetssjukhus

Lund, Sweden, 221 85

Status
Completed
 
Locations

Oslo Universitetssykehus HF, Ullevål

Oslo, Norway, 0407

Status
Terminated
 
Locations

Lady Davis Carmel Medical Center

Haifa, Israel

Status
Terminated
 
Locations

Office of Dr. Brian Lyttle, MD

London, Canada, N6A 5B8

Status
Completed
 
Locations

Montreal Chest Institute

Montreal, Canada, H2X 2P4

Status
Terminated
 
Locations

Akademiska barnsjukhuset

Uppsala, Sweden, 751 85

Status
Completed
 
Locations

SU/Östra

Göteborg, Sweden, 416 85

Status
Completed
 
Locations

H:S Rigshospitalet

Copenhagen, Denmark, 2100

Status
Completed
 
Locations

Chaim Sheba Medical Center

Tel Hashomer, Israel

Status
Completed
 
Locations

Hadassah University Hospital Mount Scopus

Jerusalem, Israel

Status
Completed
 
Locations

Rabin Medical Center - Beilinson Campus

Petach Tikva, Israel

Status
Terminated
 
Locations

Brisbane Mater Misericordiae Hospital

South Brisbane, Australia, 4101

Status
Completed
 
Locations

The Prince Charles Hospital

Chermside, Australia, 4032

Status
Completed
 
Locations

Schneider Children's Medical Center

Petach Tikva, Israel

Status
Completed
 
Locations

Rambam Medical Center

Haifa, Israel

Status
Completed
 
Locations

Sir Charles Gairdner Hospital

Nedlands, Australia, 6009

Status
Completed
 
Locations

Royal Adelaide Hospital

Adelaide, Australia, 5000

Status
Completed
 
Locations

Royal Children's Hospital Melbourne

Parkville, Australia, 3052

Status
Completed
 
Locations

Royal Children's Hospital Brisbane

Brisbane, Australia, 4029

Status
Terminated
 
Locations

Central Florida Pulmonary Group, PA

Orlando, United States, 32803

Status
Completed
 
Locations

Yale University School of Medicine

New Haven, United States, 06520

Status
Completed
 
Locations

Arnold Palmer Hospital for Children

Orlando, United States, 32806

Status
Completed
 
Locations

East Tennessee Children's Hospital

Knoxville, United States, 37916

Status
Terminated
 
Locations

Investigative Site

Iowa city, United States, 52242-1089

Status
Terminated
 
Locations

St. Christopher's Hospital for Children

Philadelphia, United States, 19134

Status
Completed
 
Locations

Investigative Site

Valhalla, United States, 10595

Status
Terminated
 
Locations

Investigative Site

Tulsa, United States, 74145

Status
Terminated
 
Locations

Children's Asthma Respiratory & Exercise Specialists

Glenview, United States, 60025

Status
Completed
 
Locations

Rady Children's Hospital–San Diego

San Diego, United States, 92123-4282

Status
Completed
 
Locations

Kentucky Clinic

Lexington, United States, 40536-0284

Status
Completed
 
Locations

The Children's Hospital

Aurora, United States, 80045

Status
Completed
 
Locations

Austin Children's Chest Associates

Austin, United States, 78723

Status
Completed
 
Locations

Universitätsklinikum Leipzig AöR

Leipzig, Germany, 04103

Status
Completed
 
Locations

Southern California Institute for Respiratory Diseases, Inc.

Los Angeles, United States, 90048

Status
Terminated
 
Locations

Monash Medical Centre

Clayton, Australia, 3168

Status
Completed
 

Trial Design