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)
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Disease, Chronic Obstructive
Intervention: Ciprofloxacin (Cipro InhaIe, BAYQ3939) (Drug); Placebo (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
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).
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Adverse event collection
Secondary outcome: Microbiological examinationCiprofloxacin concentration in sputum Ciprofloxacin concentration in plasma
Eligibility
Minimum age: 20 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Yufu, Oita 879-5593, Japan
Additional Information
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Starting date: January 2010
Last updated: April 1, 2014
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