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)

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072942
• Other study ID #: 14019
• Status: Completed
• Phase: Phase 1
• First received: January 27, 2010
• Last updated: April 1, 2014
• Start date: January 2010
• Est. completion date: July 2010

Study information

• Verified date: April 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Ciprofloxacin (Cipro InhaIe, BAYQ3939)
Ciprofloxacin Inhale 50 and 75 mg 2 times a day (BID) for 10 days
• Placebo
Placebo TID for 10 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event collection		Up to 3 weeks	Yes
Secondary	Microbiological examination		14 days	No
Secondary	Ciprofloxacin concentration in sputum		14 days	No
Secondary	Ciprofloxacin concentration in plasma		14 days	No

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