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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)

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: January 27, 2010
Last updated: April 1, 2014
Last verified: April 2014
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).

Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Ciprofloxacin (Cipro InhaIe, BAYQ3939)
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Adverse event collection [ Time Frame: Up to 3 weeks ]

Secondary Outcome Measures:
  • Microbiological examination [ Time Frame: 14 days ]
  • Ciprofloxacin concentration in sputum [ Time Frame: 14 days ]
  • Ciprofloxacin concentration in plasma [ Time Frame: 14 days ]

Enrollment: 16
Study Start Date: January 2010
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Ciprofloxacin (Cipro InhaIe, BAYQ3939)
Ciprofloxacin Inhale 50 and 75 mg 2 times a day (BID) for 10 days
Placebo Comparator: Arm 2 Drug: Placebo
Placebo TID for 10 days


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01072942

Yufu, Oita, Japan, 879-5593
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT01072942     History of Changes
Other Study ID Numbers: 14019
Study First Received: January 27, 2010
Last Updated: April 1, 2014

Keywords provided by Bayer:
Chronic Obstructive
Phase I

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors processed this record on May 24, 2017