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

NCT ID: NCT00645788

Last Updated: 2014-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2011-01-31

Brief Summary

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.

Detailed Description

Safety issues are addressed in the Adverse Events section.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

32.50 mg Ciprofloxacin DPI (BAYQ3939)

32.50 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days

Group Type: EXPERIMENTAL

Ciprofloxacin (Cipro Inhale, BAYQ3939)

Intervention Type: DRUG

32.5 mg ciprofloxacin DPI corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation powder twice a day for 28 days

48.75 mg Ciprofloxacin DPI (BAYQ3939)

48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days

Group Type: EXPERIMENTAL

Ciprofloxacin (Cipro Inhale, BAYQ3939)

Intervention Type: DRUG

48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation powder twice a day for 28 days (Arm 3 and Arm 4 was introduced after amendment 2)

Matching Placebo for 32.50 mg

Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

50 mg matching placebo powder formulation twice a day for 28 days

Matching Placebo for 48.75 mg

Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

75 mg matching placebo powder formulation twice a day for 28 days (Arm 3 and Arm 4 was introduced after amendment 2)

Interventions

Ciprofloxacin (Cipro Inhale, BAYQ3939)

32.5 mg ciprofloxacin DPI corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation powder twice a day for 28 days

Intervention Type: DRUG

Placebo

50 mg matching placebo powder formulation twice a day for 28 days

Intervention Type: DRUG

Ciprofloxacin (Cipro Inhale, BAYQ3939)

48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation powder twice a day for 28 days (Arm 3 and Arm 4 was introduced after amendment 2)

Intervention Type: DRUG

Placebo

75 mg matching placebo powder formulation twice a day for 28 days (Arm 3 and Arm 4 was introduced after amendment 2)

Intervention Type: DRUG

Eligibility 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 </=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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Phoenix, Arizona, United States

Tucson, Arizona, United States

Little Rock, Arkansas, United States

Los Angeles, California, United States

Los Angeles, California, United States

Los Angeles, California, United States

Orange, California, United States

San Diego, California, United States

San Francisco, California, United States

Ventura, California, United States

Aurora, Colorado, United States

Hartford, Connecticut, United States

New Haven, Connecticut, United States

Jacksonville, Florida, United States

Miami, Florida, United States

Orlando, Florida, United States

Orlando, Florida, United States

Orlando, Florida, United States

Augusta, Georgia, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Glenview, Illinois, United States

Maywood, Illinois, United States

Indianapolis, Indiana, United States

Iowa City, Iowa, United States

Lexington, Kentucky, United States

Louisville, Kentucky, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Ann Arbor, Michigan, United States

Kalamazoo, Michigan, United States

Jackson, Mississippi, United States

Las Vegas, Nevada, United States

Livingston, New Jersey, United States

Long Branch, New Jersey, United States

Morristown, New Jersey, United States

Somerville, New Jersey, United States

Albany, New York, United States

New Hyde Park, New York, United States

Valhalla, New York, United States

Durham, North Carolina, United States

Akron, Ohio, United States

Cincinnati, Ohio, United States

Toledo, Ohio, United States

Oklahoma City, Oklahoma, United States

Oklahoma City, Oklahoma, United States

Tulsa, Oklahoma, United States

Hershey, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Charleston, South Carolina, United States

Knoxville, Tennessee, United States

Austin, Texas, United States

San Antonio, Texas, United States

Salt Lake City, Utah, United States

Charlottesville, Virginia, United States

Seattle, Washington, United States

Madison, Wisconsin, United States

Brisbane, Queensland, Australia

Chermside, Queensland, Australia

South Brisbane, Queensland, Australia

Adelaide, South Australia, Australia

Clayton, Victoria, Australia

Parkville, Victoria, Australia

Nedlands, Western Australia, Australia

St. John's, Newfoundland and Labrador, Canada

Hamilton, Ontario, Canada

London, Ontario, Canada

Montreal, Quebec, Canada

Copenhagen, , Denmark

München, Bavaria, Germany

Frankfurt am Main, Hesse, Germany

Leipzig, Saxony, Germany

Berlin, State of Berlin, Germany

Haifa, , Israel

Jerusalem, , Israel

Petah Tikva, , Israel

Tel Litwinsky, , Israel

Oslo, , Norway

Gothenburg, , Sweden

Lund, , Sweden

Uppsala, , Sweden

Cambridge, Cambridgeshire, United Kingdom

Southampton, Hampshire, United Kingdom

Belfast, North Ireland, United Kingdom

Birmingham, West Midlands, United Kingdom

Countries

United States; Australia; Canada; Denmark; Germany; Israel; Norway; Sweden; United Kingdom

References

Dorkin HL, Staab D, Operschall E, Alder J, Criollo M. Ciprofloxacin DPI: a randomised, placebo-controlled, phase IIb efficacy and safety study on cystic fibrosis. BMJ Open Respir Res. 2015 Dec 2;2(1):e000100. doi: 10.1136/bmjresp-2015-000100. eCollection 2015.

Reference Type: DERIVED

PMID: 26688732 (View on PubMed)

Other Identifiers

2008-008314-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12429

Identifier Type: -

Identifier Source: org_study_id