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

2014-08-27 03:19:57 | BioPortfolio

Summary

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 moderate to severe COPD (stage II-III according to GOLD Criteria)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Pulmonary Disease, Chronic Obstructive

Intervention

Ciprofloxacin (PulmoSphere, BAYQ3939), Ciprofloxacin (PulmoSphere, BAYQ3939), Placebo

Location

Hannover
Niedersachsen
Germany
30625

Status

Completed

Source

Bayer

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:57-0400

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Medical and Biotech [MESH] Definitions

A broad-spectrum antimicrobial carboxyfluoroquinoline.

Hypertrophy and dilation of the RIGHT VENTRICLE of the heart that is caused by PULMONARY HYPERTENSION. This condition is often associated with pulmonary parenchymal or vascular diseases, such as CHRONIC OBSTRUCTIVE PULMONARY DISEASE and PULMONARY EMBOLISM.

Excessive accumulation of extravascular fluid in the lung, an indication of a serious underlying disease or disorder. Pulmonary edema prevents efficient PULMONARY GAS EXCHANGE in the PULMONARY ALVEOLI, and can be life-threatening.

Narrowing below the PULMONARY VALVE or well below it in the infundibuluar chamber where the pulmonary artery originates, usually caused by a defective VENTRICULAR SEPTUM or presence of fibrous tissues. It is characterized by restricted blood outflow from the RIGHT VENTRICLE into the PULMONARY ARTERY, exertional fatigue, DYSPNEA, and chest discomfort.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

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