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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystic Fibrosis

Intervention: Ciprofloxacin (Cipro Inhale, BAYQ3939) (Drug); Placebo (Drug); Ciprofloxacin (Cipro Inhale, BAYQ3939) (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Bayer

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


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.

Clinical Details

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

Primary outcome: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Day 28‑30

Secondary outcome:

Change From Baseline in FEV1 at Visits 4, 5, and Follow-up Visits 8 and 9

Change From Baseline in P. Aeruginosa Density in the Sputum at Visits 4, 5, 7, 8 and 9

Time to First Pulmonary Exacerbation Requiring Intervention

Change From Baseline in Forced Vital Capacity (FVC) at Visits 4, 5, 7, 8 and 9

Change From Baseline in Forced Expiratory Flow (FEF 25-75%) at Visits 4, 5, 7, 8 and 9

Number of Participants Developing Ciprofloxacin-resistant Mucoid P.Aeruginosa Isolates

Number of Participants Developing Ciprofloxacin-resistant Non-mucoid P.Aeruginosa Isolates

Effect of Ciprofloxacin DPI Treatment on Quality of Life Measured by Cystic Fibrosis Quality of Life Questionnaire Revised (CFQ-R), Respiratory Scale

Plasma Concentrations of Ciprofloxacin From Selected Participants During Treatment

Sputum Concentrations of Ciprofloxacin From Selected Participants During Treatment

Number of Participants With the Occurrence of Drug Induced Bronchospasms

Detailed description: Safety issues are addressed in the Adverse Events section.


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 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


- 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

Locations and Contacts

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

Additional Information

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

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Click here to find results for studies related to Bayer Healthcare products.

Starting date: May 2008
Last updated: May 30, 2014

Page last updated: August 23, 2015

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