Bayer HealthCare / Detail

 

   
   
Study to evaluate the safety and pharmacokinetics of inhaled ciprofloxacin in patients with moderate to severe chronic obstructive pulmonary disease (COPD)
 
 
 
Trial ID: 13014
 
 
 
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)
 
 
 
Indication/Disease: Pulmonary Disease, Chronic Obstructive
 
 
 
Status: Completed
Trial Start Date:2009-08-07
 
 
 
Phase: Phase I
 
 
 
Trial Type: Interventional
Purpose:Treatment, Allocation: Randomized, Masking: Single Blind, Assignment: Parallel Assignment, Number of arms:3, Number of participants: 19
 
 
 
Trial Purpose: Safety Study
 
 
 
Product: Cipro (Ciprofloxacin, BAYQ3939)
 
 
 
Intervention Type: Drug
 
 
 
Sponsor:
Collaborators:
Bayer Schering Pharma AG
Novartis Pharmaceuticals Corp.
 
 
 
Countries:
GermanyCompleted
 
 
 
Key Eligibility
Criteria:
Healthy Volunteers: No
Gender :Both
Minimum Age :40 Years
Maximum Age :75 Years

Other inclusion / exclusion criteria may apply.

 
 
 
Primary outcomes:
  • Vital signs
  • Electrocardiogram (ECG)
  • Pulmonary function test
  • Pulse-oximetry

 
 
 
Secondary outcomes:
  • Ciprofloxacin concentrations in blood
  • Ciprofloxacin concentrations in urine
  • Ciprofloxacin concentrations in sputum
  • Ciprofloxacin concentrations in mouth fluid

 
 
 
Results/Links
 
 
 
This information is provided under Bayer Healthcare's for Publication of Clinical Trial Information. Please refer to the Read This First section. © 2006 Bayer HealthCare
 
 
 
Return to results      New search       Contact for this trial
Search
Bayer HealthCare Links

Bayer scientific magazine
Clinical trials

Information about clinical studies is available at database of

Company Brochure
Company Brochure

http://www.bayerhealthcare.com/scripts/pages/en/research_development/clinical_trials/trial_finder/detail.php?trialid=13014&select_condition=&select_status=&select_location=&select_drug=&no_cache=1

Copyright © Bayer HealthCare AG