Study to Evaluate the Safety and Pharmacokinetics of Inhaled Ciprofloxacin in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
With
Novartis
Age
35–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Study to Evaluate the Safety and Pharmacokinetics of Inhaled Ciprofloxacin in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)
