check_circleStudy Completed

Pulmonary Disease, Chronic Obstructive

Bayer Identifier:

14019

ClinicalTrials.gov Identifier:

NCT01072942

EudraCT Number:

Not Available

EU CT Number:

Not Available
To evaluate the safety, tolerability, pulmonary deposition, pharmacokinetics and pharmacodynamics of ciprofloxacin inhale in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD, GOLD II-III)

Trial purpose

The study will be conducted in a single-center, randomized, single-blinded, placebo-controlled, dose escalation design with two dose groups.Multiple-dose inhalation of Ciprofloxacin inhale 50 and 75 mg or placebo will be administered to 16 Japanese patients with COPD in totalPatients with moderate to severe COPD, stage II or III according to GOLD criteria, will participate in the study.The study will consist of 2 steps as indicated below; starting at Step 1 (50 mg) and escalating doses up to Step 2 (75 mg), after the tolerability of the dose in the previous step is confirmed. In each step, the study will be conducted as multiple dose study with b.i.d. regimen for 10 days (between day 2 and 11) in a randomized, single-blind, placebo-controlled design. In addition, before and after the multiple dose administration, single administration will be conducted in each subject (day 0 and 12).

Key Participants Requirements

Sex

Both

Age

20 - 80 Years
  • - Adult patients with COPD, 40 to 80 years of age
    - All patients must have a diagnosis of COPD and must meet the following spirometric criteria: Patients must have relatively stable airway obstruction with a post-bronchodilator 30%
  • - Patients with a significant respiratory disease other than COPD. A significant disease is defined as a disease which, in the opinion of the investigator
    - Patients with a medical disorder, condition or history of such that would impair the patients ability to participate or complete this study in the opinion of the investigator, patients who have mental disorder which is inappropriate to communal living in a participation in a clinical study, who have no ability to give informed consent, or who have physical disability
    - Patients with a history of CF
    - Patients with clinically evident bronchiectasis
    - Patients with a history of asthma
    - Patients who have undergone thoracotomy with pulmonary resection
    - Patients with relevant conspicuous findings in medical history and pre-study examination not related to the underlying disease

Trial summary

Enrollment Goal
16
Trial Dates
January 2010 - July 2010
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Ciprofloxacin DPI (BAYQ3939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Yufu, 879-5593, Japan

Primary Outcome

  • Adverse event collection
    date_rangeTime Frame:
    Up to 3 weeks
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Microbiological examination
    date_rangeTime Frame:
    14 days
    enhanced_encryption
    Safety Issue:
    no
  • Ciprofloxacin concentration in sputum
    date_rangeTime Frame:
    14 days
    enhanced_encryption
    Safety Issue:
    no
  • Ciprofloxacin concentration in plasma
    date_rangeTime Frame:
    14 days
    enhanced_encryption
    Safety Issue:
    no

Trial design

Randomized, single-blinded, placebo-controlled study to evaluate the safety, tolerability, pulmonary deposition, pharmacokinetics and pharmacodynamics of ciprofloxacin in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD; GOLD II-III), following multiple 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
2

Additional Information

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