Study in COPD (Chronic Obstructive Pulmonary Disease) Subjects to Investigate Safety, Tolerability, and Pharmacokinetics of Ciprofloxacin After Single Dose Inhalations of 50 mg and 75 mg Ciprofloxacin Inhalation Powder
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
40–75
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Adult subjects with COPD, 40 - 75 years of age
All subjects must have a diagnosis of COPD and must have airway obstruction with a post-bronchodilator Forced Expiratory Volume in 1 sec (FEV1) of \>/= 30% and \<= 80% of predicted and a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) of \</= 70%
Subjects must be current or ex-smokers with a smoking history of more than 10 pack-years
Subjects must be able to perform technically acceptable pulmonary function tests during the study period as required in the protocol
Subjects must be able to produce an sufficient amount of sputum during sputum induction at screening
You may not be if
Subjects with a significant respiratory disease other than COPD.
Exacerbation within 8 weeks prior to screening
Subjects with more than 1 COPD exacerbation within 12 months prior to screening
Subjects must have an FEV1 of at least one Liter
Subjects with a history or physician's diagnosis of asthma. If a patient has a total blood eosinophil count \>/= 0.6 x 10\^9/L source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition.
Subjects with hypersensitivity to the ciprofloxacin or to other quinolones and/or to inactive constituents of the inhalation powder
Subjects with known hypersensitivity of the bronchial system to inhalation of nebulized drugs or saline solution
Subjects with a history of cystic fibrosis
Subjects with clinically evident bronchiectasis
Subjects taking any:
* Oral beta-adrenergic drugs or non cardioselective beta blockers,
* Oral glucocorticoids,
* Antihistamines or antileukotrienes prescribed for asthma,
* Oral cromolyn sodium or oral nedocromil sodium,
* Concomitant inhalative therapy with antibiotics and / or concomitant systemic therapy with fluoroquinolones
Clareo Health | Study in COPD (Chronic Obstructive Pulmonary Disease) Subjects to Investigate Safety, Tolerability, and Pharmacokinetics of Ciprofloxacin After Single Dose Inhalations of 50 mg and 75 mg Ciprofloxacin Inhalation Powder
