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Study to Evaluate the Safety and Pharmacokinetics of Inhaled Ciprofloxacin in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00961038
First received: August 17, 2009
Last updated: March 21, 2013
Last verified: March 2013
History of Changes
  Purpose

Objectives of the study are to investigate the safety, tolerability and levels of ciprofloxacin in the lung after single and multiple inhalative administration to patients with moderate to severe COPD (stage II-III according to GOLD Criteria)


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
 Drug: Ciprofloxacin (PulmoSphere, BAYQ3939)
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized, Single-Blinded, Placebo-Controlled Study to Evaluate the Safety and Tolerability, the Pulmonary Deposition and Pharmacokinetics of Ciprofloxacin in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (GOLD II - III), Following Inhalation of Ciprofloxacin PulmoSphere® Inhalation Powder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Vital signs [ Time Frame: Within 28 days after first treatment ] [ Designated as safety issue: Yes ]
  • Electrocardiogram (ECG) [ Time Frame: Within 28 days after first treatment ] [ Designated as safety issue: Yes ]
  • Pulmonary function test [ Time Frame: Within 28 days after first treatment ] [ Designated as safety issue: Yes ]
  • Pulse-oximetry [ Time Frame: Within 12 days after first treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ciprofloxacin concentrations in blood [ Time Frame: Within 14 days after first treatment ] [ Designated as safety issue: No ]
  • Ciprofloxacin concentrations in urine [ Time Frame: Within 14 days after first treatment ] [ Designated as safety issue: No ]
  • Ciprofloxacin concentrations in sputum [ Time Frame: Within 14 days after first treatment ] [ Designated as safety issue: No ]
  • Ciprofloxacin concentrations in mouth fluid [ Time Frame: Within 7 days after first treatment ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: August 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Ciprofloxacin (PulmoSphere, BAYQ3939)
32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin PulmoSphere inhalation powder will be given as an initial single-dose inhalation (day 0).During the multiple-dose phase (day 2 to day 11), the same dose will be given twice daily, with a concluding single dose (on day 12)
Experimental: Arm 2 Drug: Ciprofloxacin (PulmoSphere, BAYQ3939)
48,75 mg ciprofloxacin betaine corresponding to 75 mg Ciprofloxacin PulmoSphere inhalation powder will be given as an initial single-dose inhalation (day 0).During the multiple-dose phase (day 2 to day 11), the same dose will be given twice daily, with a concluding single dose (on day 12)
Placebo Comparator: Arm 3 Drug: Placebo
Placebo inhalation powder will be given as an initial single-dose inhalation (day 0).During the multiple-dose phase (day 2 to day 11), placebo will be given twice daily, with a concluding single dose (on day 12)

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with COPD, 40 to 75 years of age
  • Diagnosis of COPD
  • Airway obstruction with a post-bronchodilator Forced Expiratory Volume (FEV1) of >/=30% and </=65% of predicted and a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) of </=70%
  • Current or ex-smokers with a smoking history of more than 10 pack-years
  • Patients must be able to produce acceptable induced sputum samples (as defined in the Study Procedure Manual)
  • Normal body weight: Body Mass Index (BMI) between 19 and 35 kg/m2

Exclusion Criteria:

  • Significant respiratory disease other than COPD as bronchial asthma, Cystic fibrosis or clinically evident bronchiectasis
  • More than one COPD exacerbation within 12 months and within 8 weeks prior to screening
  • total blood eosinophil count >/=600/mm3
  • Thoracotomy with pulmonary resection
  • Regularly use of daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits
  • Hypersensitivity to the investigational drug or to other quinolones and/or to inactive constituents of the inhalation powder
  • Hypersensitivity of the bronchial system to inhalation of nebulized drugs or saline solution
  • Patients with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies
  • Concomitant use of medication which could interfere with the investigational drug. Before study drug administration a wash out period of more than 5 half lives has to be considered

  • Concomitant inhalative therapy with antibiotics and/or concomitant systemic therapy with

    • fluoroquinolones
    • Oral beta-andrenergics, beta blockers
    • oral steroids
    • Methylxanthines: 24-hour washout of short-acting theophylline and 48-hour washout of long-acting theophylline prior to pre-study examination
    • Antihistamines, antileukotrienes prescribed for asthma
    • oral cromolyn sodium or oral nedocromil sodium
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00961038

Locations
Germany
Hannover, Niedersachsen, Germany, 30625
Sponsors and Collaborators
Bayer
Novartis Pharmaceuticals
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00961038     History of Changes
Other Study ID Numbers: 13014, 2008-006771-79
Study First Received: August 17, 2009
Last Updated: March 21, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Ciprofloxacin
Inhalation
Pharmacokinetics
 Safety
Tolerability
COPD

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
 Ciprofloxacin
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013