check_circleStudy Completed

Pulmonary Disease, Chronic Obstructive

Study to evaluate the safety and pharmacokinetics of inhaled ciprofloxacin in patients with moderate to severe chronic obstructive pulmonary disease (COPD)

Trial 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)

Key Participants Requirements

Sex

Both

Age

40 - 75 Years

Trial summary

Enrollment Goal
19
Trial Dates
August 2009 - March 2010
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Ciprofloxacin DPI (BAYQ3939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Hannover, 30625, Germany

Primary Outcome

  • Vital signs
    date_rangeTime Frame:
    Within 28 days after first treatment
    enhanced_encryption
    Safety Issue:
    yes
  • Electrocardiogram (ECG)
    date_rangeTime Frame:
    Within 28 days after first treatment
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    Safety Issue:
    yes
  • Pulmonary function test
    date_rangeTime Frame:
    Within 28 days after first treatment
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    Safety Issue:
    yes
  • Pulse-oximetry
    date_rangeTime Frame:
    Within 12 days after first treatment
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    Safety Issue:
    yes

Secondary Outcome

  • Ciprofloxacin concentrations in blood
    date_rangeTime Frame:
    Within 14 days after first treatment
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    Safety Issue:
    no
  • Ciprofloxacin concentrations in urine
    date_rangeTime Frame:
    Within 14 days after first treatment
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    Safety Issue:
    no
  • Ciprofloxacin concentrations in sputum
    date_rangeTime Frame:
    Within 14 days after first treatment
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    Safety Issue:
    no
  • Ciprofloxacin concentrations in mouth fluid
    date_rangeTime Frame:
    Within 7 days after first treatment
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    Safety Issue:
    no

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Single Blind
Assignment
Parallel Assignment
Trial Arms
3