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)

NCT01072942 | Completed Phase 1

• 1 other identifier: 14019
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Keywords

Chronic Obstructive; Phase I; Pharmacokinetics; Microbiology

Outcome Measures

Primary Outcomes (1)

• Adverse event collection

  Up to 3 weeks

Secondary Outcomes (3)

• Microbiological examination

  14 days

• Ciprofloxacin concentration in sputum

  14 days

• Ciprofloxacin concentration in plasma

  14 days

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: Ciprofloxacin (Cipro InhaIe, BAYQ3939)

Arm 2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ciprofloxacin (Cipro InhaIe, BAYQ3939) DRUG

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

Arm 1

Placebo DRUG

Placebo TID for 10 days

Arm 2

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Yufu, Oita Prefecture, 879-5593, Japan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2010
• First Posted: February 22, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2010
• Last Updated: April 2, 2014

Record last verified: 2014-04

Locations

JP (1)