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

NCT00645788 | Completed Phase 2 Results DMC

• 2 other identifiers: 124292008-008314-40
• Study Type: interventional
• Target: 288
• Locations: 9 countries
• Sites: 86

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.

Conditions

Cystic Fibrosis

Keywords

Ciprofloxacin; cystic fibrosis; sweat test; pulmonary function test

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Day 28-30

  FEV1: The maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS). This was recorded at the site using a spirometer. The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.

  Baseline and End of treatment (Day 28-30)

Secondary Outcomes (11)

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

  Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).

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

  Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).

• Time to First Pulmonary Exacerbation Requiring Intervention

  Up to visit 9 (Day 56-60)

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

  Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).

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

  Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).

Study Arms (4)

32.50 mg Ciprofloxacin DPI (BAYQ3939)

EXPERIMENTAL

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

Drug: Ciprofloxacin (Cipro Inhale, BAYQ3939)

48.75 mg Ciprofloxacin DPI (BAYQ3939)

EXPERIMENTAL

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

Drug: Ciprofloxacin (Cipro Inhale, BAYQ3939)

Matching Placebo for 32.50 mg

PLACEBO COMPARATOR

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

Drug: Placebo

Matching Placebo for 48.75 mg

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ciprofloxacin (Cipro Inhale, BAYQ3939) DRUG

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

32.50 mg Ciprofloxacin DPI (BAYQ3939)

Placebo DRUG

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

Matching Placebo for 32.50 mg

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead
• Novartis: collaborator

Study Sites (86)

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Phoenix, Arizona, 85016, United States

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Tucson, Arizona, 85724, United States

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Little Rock, Arkansas, 72205, United States

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Los Angeles, California, 90027, United States

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Los Angeles, California, 90033, United States

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Los Angeles, California, 90048, United States

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Orange, California, 92868, United States

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San Diego, California, 92123-4282, United States

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San Francisco, California, 94143, United States

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Ventura, California, 93003, United States

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Aurora, Colorado, 80045, United States

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Hartford, Connecticut, 06102, United States

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New Haven, Connecticut, 06520, United States

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Jacksonville, Florida, 32207, United States

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Miami, Florida, 33136, United States

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Orlando, Florida, 32801, United States

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Orlando, Florida, 32803, United States

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Orlando, Florida, 32806, United States

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Augusta, Georgia, 30912-4005, United States

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Chicago, Illinois, 60612, United States

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Chicago, Illinois, 60614, United States

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Glenview, Illinois, 60025, United States

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Maywood, Illinois, 60153, United States

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Indianapolis, Indiana, 46202, United States

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Iowa City, Iowa, 52242-1089, United States

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Lexington, Kentucky, 40536-0284, United States

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Louisville, Kentucky, 40207, United States

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Boston, Massachusetts, 02111, United States

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Boston, Massachusetts, 02115, United States

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Ann Arbor, Michigan, 48109, United States

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Kalamazoo, Michigan, 49007, United States

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Jackson, Mississippi, 39216, United States

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Las Vegas, Nevada, 89107, United States

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Livingston, New Jersey, 07039, United States

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Long Branch, New Jersey, 07740, United States

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Morristown, New Jersey, 07962, United States

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Somerville, New Jersey, 08876, United States

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Albany, New York, 12208, United States

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New Hyde Park, New York, 11040, United States

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Valhalla, New York, 10595, United States

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Durham, North Carolina, 27710, United States

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Akron, Ohio, 44308-1062, United States

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Cincinnati, Ohio, 45229-3039, United States

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Toledo, Ohio, 43606, United States

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Oklahoma City, Oklahoma, 73104, United States

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Oklahoma City, Oklahoma, 73112, United States

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Tulsa, Oklahoma, 74145, United States

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Hershey, Pennsylvania, 17033-0850, United States

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Philadelphia, Pennsylvania, 19104-4283, United States

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Philadelphia, Pennsylvania, 19134, United States

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Charleston, South Carolina, 29425, United States

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Knoxville, Tennessee, 37916, United States

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Austin, Texas, 78723, United States

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San Antonio, Texas, 78212, United States

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Salt Lake City, Utah, 84132, United States

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Charlottesville, Virginia, 22908, United States

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Seattle, Washington, 98105, United States

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Madison, Wisconsin, 53792, United States

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Brisbane, Queensland, 4029, Australia

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Chermside, Queensland, 4032, Australia

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South Brisbane, Queensland, 4101, Australia

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Adelaide, South Australia, 5000, Australia

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Clayton, Victoria, 3168, Australia

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Parkville, Victoria, 3052, Australia

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Nedlands, Western Australia, 6009, Australia

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

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Hamilton, Ontario, L8S 4J9, Canada

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London, Ontario, N6A 5B8, Canada

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Montreal, Quebec, H2X 2P4, Canada

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Copenhagen, 2100, Denmark

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München, Bavaria, 80336, Germany

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Frankfurt am Main, Hesse, 60590, Germany

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Leipzig, Saxony, 04103, Germany

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Berlin, State of Berlin, 12200, Germany

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Haifa, Israel

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Jerusalem, Israel

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Petah Tikva, Israel

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Tel Litwinsky, Israel

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Oslo, 0407, Norway

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Gothenburg, 416 85, Sweden

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Lund, 221 85, Sweden

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Uppsala, 751 85, Sweden

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Cambridge, Cambridgeshire, CB3 8RE, United Kingdom

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Southampton, Hampshire, SO16 6YD, United Kingdom

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Belfast, North Ireland, BT12 7AB, United Kingdom

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Birmingham, West Midlands, B9 5SS, United Kingdom

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Related Publications (1)

• 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.

  PMID: 26688732 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2008
• First Posted: March 28, 2008
• Study Start: May 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: June 9, 2014
• Results First Posted: July 3, 2012

Record last verified: 2014-05

Locations

NO (1); AU (7); DE (4); US (58); GB (4); SE (3); IL (4); DK (1); CA (4)