Study to Characterize Lung Deposition, Pharmacokinetics, Safety and Tolerability of Single Inhalations of Radiolabeled Ciprofloxacin Dry Powder in Healthy Subjects and Patients With Chronic Lung Diseases

Exclusion Criteria

• •Known hypersensitivity, allergy or intolerance to study drug formulation ingredients
• •Febrile illness within 1 week prior to screening visit
• •Concomitant severe diseases (judged by the investigator) or diseases which are contraindications for the use of inhaled ciprofloxacin
• •Use of ciprofloxacin within 30 days before screening visit
• •Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them, e.g. systemic administration of antibiotics which are subject to renal excretion (e.g. beta-lactam antibiotics, levofloxacin, ofloxacin, etc.), furosemide and antacids
• •Donation of more than 450 mL of blood within 4 weeks before screening visit
• •Clinically relevant findings in the ECG
• •Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation
• •Participation in another clinical study less than 8 weeks prior to screening visit
• •Pulmonary exacerbation within the 6 weeks prior to screening
• •History of lung transplant or any lung surgery or on any thoracic surgery waiting list
• •* Lung function measurements outside normal limits (Normal values: FEV1/FVC \> 70% and FEV1 and FVC \> 80% of predicted)
• •* Regular use of daytime oxygen therapy
• •* Diagnosis of bronchial asthma
• •* Diagnosis of clinically evident bronchiectasis (COPD patients)
• •* Total blood eosinophil count \>/= 600/mm3.
• •* Completion of a pulmonary rehabilitation program in the six weeks prior to screening visit or current participation in a pulmonary rehabilitation program
• •* Change in dose or type of any medications within 4 weeks prior to the screening visit