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)

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01072942

Enrollment

Registered

2010-02-22

Start date

2010-01-31

Completion date

2010-07-31

Last updated

2014-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive, Phase I, Pharmacokinetics, Microbiology

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).

Interventions

DRUGCiprofloxacin (Cipro InhaIe, BAYQ3939)

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

DRUGPlacebo

Placebo TID for 10 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Adverse event collection	Up to 3 weeks

Secondary

Measure	Time frame
Microbiological examination	14 days
Ciprofloxacin concentration in sputum	14 days
Ciprofloxacin concentration in plasma	14 days

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026