Back to resultsTo 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)
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Ciprofloxacin (Cipro InhaIe, BAYQ3939)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Chronic Obstructive, Phase I, Pharmacokinetics, Microbiology
Eligibility Criteria
Inclusion Criteria:
- 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% </= Forced Expiratory Volume (FEV1) </= 65% of predicted normal. And a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) <70%.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Adverse event collection
Secondary Outcome Measures
Microbiological examination
Ciprofloxacin concentration in sputum
Ciprofloxacin concentration in plasma
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01072942
Brief Title
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)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Chronic Obstructive, Phase I, Pharmacokinetics, Microbiology
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin (Cipro InhaIe, BAYQ3939)
Intervention Description
Ciprofloxacin Inhale 50 and 75 mg 2 times a day (BID) for 10 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo TID for 10 days
Primary Outcome Measure Information:
Title
Adverse event collection
Time Frame
Up to 3 weeks
Secondary Outcome Measure Information:
Title
Microbiological examination
Time Frame
14 days
Title
Ciprofloxacin concentration in sputum
Time Frame
14 days
Title
Ciprofloxacin concentration in plasma
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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% </= Forced Expiratory Volume (FEV1) </= 65% of predicted normal. And a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) <70%.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Yufu
State/Province
Oita
ZIP/Postal Code
879-5593
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
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)
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