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:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01072942
First received: January 27, 2010
Last updated: March 21, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 More Information
Additional Information:
No publications provided
| Responsible Party: | Head Medical Development Japan, Bayer Yakuhin Ltd. |
| ClinicalTrials.gov Identifier: | NCT01072942 History of Changes |
| Other Study ID Numbers: | 14019 |
| Study First Received: | January 27, 2010 |
| Last Updated: | March 21, 2013 |
| 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 Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases |
Ciprofloxacin Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013