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)

Phase 1

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Ciprofloxacin (Cipro InhaIe, BAYQ3939); Drug: Placebo

• Registration Number: NCT01072942
• Lead Sponsor: Bayer

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-27
• Study First Submitted QC: 2010-02-19
• Study First Posted: 2010-02-22
• Primary Completion: 2010-06
• Study Completion: 2010-07
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-01
• Last Update Posted: 2014-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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%.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Ciprofloxacin (Cipro InhaIe, BAYQ3939)	-
Arm 2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Adverse event collection	Up to 3 weeks

Secondary Outcome Measures

Name	Time	Method
Microbiological examination	14 days
Ciprofloxacin concentration in sputum	14 days
Ciprofloxacin concentration in plasma	14 days