Study to Evaluate the Safety and Pharmacokinetics of Inhaled Ciprofloxacin in Patients With Moderate to Severe 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 Pharmaceuticals
Age
40–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult patients with COPD, 40 to 75 years of age
Diagnosis of COPD
Airway obstruction with a post-bronchodilator Forced Expiratory Volume (FEV1) of \>/=30% and \</=65% of predicted and a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) of \</=70%
Current or ex-smokers with a smoking history of more than 10 pack-years
Patients must be able to produce acceptable induced sputum samples (as defined in the Study Procedure Manual)
Normal body weight: Body Mass Index (BMI) between 19 and 35 kg/m2
You may not be if
Significant respiratory disease other than COPD as bronchial asthma, Cystic fibrosis or clinically evident bronchiectasis
More than one COPD exacerbation within 12 months and within 8 weeks prior to screening
total blood eosinophil count \>/=600/mm3
Thoracotomy with pulmonary resection
Regularly use of daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits
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
Patients with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies
Concomitant use of medication which could interfere with the investigational drug. Before study drug administration a wash out period of more than 5 half lives has to be considered
Concomitant inhalative therapy with antibiotics and/or concomitant systemic therapy with
* fluoroquinolones
* Oral beta-andrenergics, beta blockers
* 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 Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
