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)

NCT ID: NCT01072942

Last Updated: 2014-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-07-31

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).

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Ciprofloxacin (Cipro InhaIe, BAYQ3939)

Intervention Type: DRUG

Ciprofloxacin Inhale 50 and 75 mg 2 times a day (BID) for 10 days

Arm 2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo TID for 10 days

Interventions

Ciprofloxacin (Cipro InhaIe, BAYQ3939)

Ciprofloxacin Inhale 50 and 75 mg 2 times a day (BID) for 10 days

Intervention Type: DRUG

Placebo

Placebo TID for 10 days

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Yufu, Oita Prefecture, Japan

Countries

Japan

Other Identifiers

14019

Identifier Type: -

Identifier Source: org_study_id