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Study in COPD (Chronic Obstructive Pulmonary Disease) Subjects to Investigate Safety, Tolerability, and Pharmacokinetics of Ciprofloxacin After Single Dose Inhalations of 50 mg and 75 mg Ciprofloxacin Inhalation Powder

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ClinicalTrials.gov Identifier: NCT01168895
Recruitment Status : Completed
First Posted : July 23, 2010
Last Update Posted : April 14, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
The purpose of this study is to compare the safety and pharmacokinetics of ciprofloxacin after inhalation of single 52.5 and 48.75 mg doses in COPD patients. In this study the 48.75 mg dose will be administered for the first time using a new high dose strength (i.e. one capsule containing 75 mg powder = 48.75 mg ciprofloxacin) formulation. Safety investigations will focus on local tolerability in the lung and evaluate whether the patient can inhale the higher amount of powder compared to the lower dose strength. Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the study drug. Results from this study will be used to decide whether the new dose strength is suitable for larger clinical trials planned for the COPD patients population.

Condition or disease Intervention/treatment Phase
Infection Pulmonary Disease, Chronic Obstructive Drug: Cipro Inhale (Ciprofloxacin, BAYQ3939) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Cross-over Study in COPD Subjects to Investigate Safety, Tolerability, and Pharmacokinetics of Ciprofloxacin After Single Dose Inhalations of 50 mg and 75 mg Ciprofloxacin Inhalation Powder
Study Start Date : July 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1 Drug: Cipro Inhale (Ciprofloxacin, BAYQ3939)
32.5 mg ciprofloxacin corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as single dose inhalation
Experimental: Arm 2 Drug: Cipro Inhale (Ciprofloxacin, BAYQ3939)
48.75 mg ciprofloxacin corresponding to 75 mg Ciprofloxacin Pulmosphere inhalation powder will be given as single dose inhalation


Outcome Measures
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Primary Outcome Measures :
  1. Determination of ciprofloxacin pharmacokinetics derived from drug concentrations in blood, urine and sputum [ Time Frame: Within 24 hours after treatment ]

Secondary Outcome Measures :
  1. Adverse events collection [ Time Frame: Within 30 days ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult subjects with COPD, 40 - 75 years of age
  • All subjects must have a diagnosis of COPD and must have airway obstruction with a post-bronchodilator Forced Expiratory Volume in 1 sec (FEV1) of >/= 30% and <= 80% of predicted and a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) of </= 70%
  • Subjects must be current or ex-smokers with a smoking history of more than 10 pack-years
  • Subjects must be able to perform technically acceptable pulmonary function tests during the study period as required in the protocol
  • Subjects must be able to produce an sufficient amount of sputum during sputum induction at screening

Exclusion Criteria:

  • Subjects with a significant respiratory disease other than COPD.
  • Exacerbation within 8 weeks prior to screening
  • Subjects with more than 1 COPD exacerbation within 12 months prior to screening
  • Subjects must have an FEV1 of at least one Liter
  • Subjects with a history or physician's diagnosis of asthma. If a patient has a total blood eosinophil count >/= 0.6 x 10^9/L source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition.
  • Subjects with hypersensitivity to the ciprofloxacin or to other quinolones and/or to inactive constituents of the inhalation powder
  • Subjects with known hypersensitivity of the bronchial system to inhalation of nebulized drugs or saline solution
  • Subjects with a history of cystic fibrosis
  • Subjects with clinically evident bronchiectasis

  • Subjects taking any:

    • Oral beta-adrenergic drugs or non cardioselective beta blockers,
    • Oral glucocorticoids,
    • Antihistamines or antileukotrienes prescribed for asthma,
    • Oral cromolyn sodium or oral nedocromil sodium,
    • Concomitant inhalative therapy with antibiotics and / or concomitant systemic therapy with fluoroquinolones
Contacts and Locations
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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): NCT01168895


Locations
Germany
Großhansdorf, Schleswig-Holstein, Germany, 22927
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information
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Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01168895     History of Changes
Other Study ID Numbers: 14972
2010-018521-19 ( EudraCT Number )
First Posted: July 23, 2010    Key Record Dates
Last Update Posted: April 14, 2014
Last Verified: April 2014

Keywords provided by Bayer:
75 mg dose strength
Safety
Pharmacokinetics

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Aspiration
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiration Disorders
Pathologic Processes
Disease Attributes
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