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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:
ClinicalTrials.gov Identifier:
NCT00961038
First Posted: August 18, 2009
Last Update Posted: April 1, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Bayer
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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:


Further study details as provided by Bayer:

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

Secondary Outcome Measures:
  • Ciprofloxacin concentrations in blood [ Time Frame: Within 14 days after first treatment ]
  • Ciprofloxacin concentrations in urine [ Time Frame: Within 14 days after first treatment ]
  • Ciprofloxacin concentrations in sputum [ Time Frame: Within 14 days after first treatment ]
  • Ciprofloxacin concentrations in mouth fluid [ Time Frame: Within 7 days after first treatment ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00961038


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00961038     History of Changes
Other Study ID Numbers: 13014
2008-006771-79 ( EudraCT Number )
First Submitted: August 17, 2009
First Posted: August 18, 2009
Last Update Posted: April 1, 2014
Last Verified: March 2014

Keywords provided by Bayer:
Ciprofloxacin
Inhalation
Pharmacokinetics
Safety
Tolerability
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors