Disease, Pulmonary
Conditions
Keywords
Ciprofloxacin, Inhalation, Pharmacokinetics, Safety, Tolerability, COPD
Brief 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 mild to moderate COPD (stage I-II according to GOLD Criteria).
Interventions
32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given twice daily (bid) with a concluding single dose on 11d.
DRUGPlacebo
Placebo inhalation powder will be given as an initial single dose inhalation on 00d.During the multiple dose phase placebo will be given twice/three-times daily with a concluding single dose on day 11d.
Sponsors
Novartis
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulse oximetry by peripheral oxygen concentration | Within 12 days after first treatment |
| Vital signs: evaluated by heart rate, blood pressure, clinical laboratory | Within 28 days after first treatment |
| Electrocardiogram: evaluated by shape and time intervals | Within 28 days after first treatment |
| Pulmonary function test evaluated by FEV1 | Within 28 days after first treatment |
Secondary
| Measure | Time frame |
|---|---|
| Determination of ciprofloxacin concentration in oral rinsing fluid | Within 7 days after first treatment |
| Determination of ciprofloxacin concentration in blood | Within 14 days after first treatment |
| Determination of ciprofloxacin concentration in urine | Within 14 days after first treatment |
| Determination of ciprofloxacin concentration in sputum | Within 14 days after first treatment |
Countries
Germany
Outcome results
None listed