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.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01072942
First received: January 27, 2010
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Microbiological examination [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Ciprofloxacin concentration in sputum [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Ciprofloxacin concentration in plasma [ Time Frame: 14 days ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072942

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01072942     History of Changes
Other Study ID Numbers: 14019
Study First Received: January 27, 2010
Last Updated: April 1, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
Chronic Obstructive
Phase I
Pharmacokinetics
Microbiology

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 26, 2014