Study to Evaluate the Safety and Pharmacokinetics of Inhaled Ciprofloxacin in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
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Brief Summary
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Objectives of the study are to investigate the safety, tolerability and levels of ciprofloxacin in the lung after single and multiple inhalative administration to patients with mild to moderate COPD (stage I-II according to GOLD Criteria).

Official Title
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Randomized, Single-blinded, Placebo-controlled Study to Evaluate the Safety and Tolerability, the Pulmonary Deposition and Pharmacokinetics of Ciprofloxacin in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease (GOLD I - II), Following Inhalation of Ciprofloxacin PulmoSphere Inhalation Powder.

Conditions
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Disease, Pulmonary

Intervention / Treatment
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* Drug: Ciprofloxacin (Cipro inhale, BAYQ3939)
* Drug: Ciprofloxacin (Cipro inhale, BAYQ3939)
* Drug: Ciprofloxacin (Cipro inhale, BAYQ3939)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with COPD (Stage I or II according to the GOLD Classification), 35 years of age or older Airway obstruction with a post-bronchodilator Forced Expiratory Volume (FEV1) > or equal 50% of predicted normal and a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) < 70%. Current or ex-smokers with a smoking history of more than 10 pack-years Body mass index (BMI) between 18 and 33 kg/m2 Written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures Exclusion Criteria: Significant disease other than COPD as bronchial asthma, cystic fibrosis or clinically evident bronchiectasis Total blood eosinophil count >/=600/mm3. Thoracotomy with pulmonary resection Regular use of daytime oxygen therapy Completion of a pulmonary rehabilitation program in the six weeks prior to the pre-study examination or current participation in a rehabilitation program Hypersensitivity to the investigational drug or to other quinolones and/or to inactive constituents of the inhalation powder Hypersensitivity of the bronchial system to inhalation of nebulized drugs or saline solution Acute pulmonary exacerbation Patients with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies Concomitant inhalative therapy with antibiotics and/or concomitant systemic therapy with fluoroquinolones Oral beta-adrenergics, beta blockers Long acting anti-cholinergics within 2 weeks prior to pre-study examination Inhaled or oral steroids Methylxanthines: 24-hour washout of short-acting theophylline and 48-hour washout of long-acting theophylline prior to pre-study examination Antihistamines, antileukotrienes prescribed for asthma oral cromolyn sodium or oral nedocromil sodium

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Ciprofloxacin (Cipro inhale, BAYQ3939)<br>* 32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given twice daily (bid) with a concluding single dose on 11d.<br>|
| Experimental: Arm 2<br> | Drug: Ciprofloxacin (Cipro inhale, BAYQ3939)<br>* 32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given three times daily (tid) with a concluding single dose on 11d.<br>|
| Experimental: Arm 3<br> | Drug: Ciprofloxacin (Cipro inhale, BAYQ3939)<br>* 48.75 mg ciprofloxacin betaine corresponding to 75 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given twice daily (bid) with a concluding single dose on 11d.<br>|
| Placebo Comparator: Arm 4<br> | Drug: Placebo<br>* Placebo inhalation powder will be given as an initial single dose inhalation on 00d.During the multiple dose phase placebo will be given twice/three-times daily with a concluding single dose on day 11d.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs: evaluated by heart rate, blood pressure, clinical laboratory |  | Within 28 days after first treatment | 
| Electrocardiogram: evaluated by shape and time intervals |  | Within 28 days after first treatment | 
| Pulmonary function test evaluated by FEV1 |  | Within 28 days after first treatment | 
| Pulse oximetry by peripheral oxygen concentration |  | Within 12 days after first treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of ciprofloxacin concentration in blood |  | Within 14 days after first treatment | 
| Determination of ciprofloxacin concentration in urine |  | Within 14 days after first treatment | 
| Determination of ciprofloxacin concentration in sputum |  | Within 14 days after first treatment | 
| Determination of ciprofloxacin concentration in oral rinsing fluid |  | Within 7 days after first treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ciprofloxacin, Inhalation, Pharmacokinetics, Safety, Tolerability, COPD