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

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