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Study Name: Tiotropium Bromide (Spiriva) Safety and Effectiveness in People with Cystic Fibrosis
Study Type: Interventional
Intervention Category: Other
Study Sponsor: BI
Study Phase: 3
Recruitment Status: Trial Completed
Study Drug(s): Tiotropium Bromide
Number of Participants Being Recruited: 450
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This study will look at the safety and effectiveness of tiotropium bromide(Spiriva) inhaled once a day using the Respimat device in children who are less than 12 years of age (and able to perform an acceptable spirometry) and children over 12 years and adults with Cystic Fibrosis.
ELIGIBILITY
Age: >= 1 Days
FEV1: >= 26 Percent Predicted
P. aeruginosa status: Not applicable
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
FOR MORE INFORMATION:
Sponsor Contact Information: Koker, Paul
(203) 798-4489
pkoker@rdg.boehringer-ingelheim.com
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/ct2/show/NCT01179347?term=spiriva+and+cystic+fibrosis&rank=1
Clinical Research Terms Glossary: Click here
PARTICIPATING SITES:
The sites listed below are currently recruiting subjects. Please note that this list generally lists either the pediatric or adult program but not both even though both programs may be recruiting subjects. Also, this list does not include sites that may be participating in the study but are not yet open for recruitment. If you are interested in this study please contact your center for more information.
AZ
  • Tucson CF Center (Pediatric and Adult), Tucson, AZ, 85724
    Contact Information:
        Molina de Rodriguez, Osmara
        Phone: (520) 891-6767
        Email: omolina@email.arizona.edu
CA
  • University of California San Diego -Thornton (Adult), La Jolla, CA, 92037
    Contact Information:
        Shaw, Kevin
        Phone: (858) 657-7119
        Email: kdshaw@ucsd.edu
FL
  • Nemours Children's Clinic - Jacksonville (Pediatric), Jacksonville, FL, 32207
    Contact Information:
        DeLuca, Elizabeth
        Phone: (904) 697-3804
        Email: Elizabeth.DeLuca@nemours.org
  • Nemours Children's Clinic - Orlando (Pediatric), Orlando, FL, 32806
    Contact Information:
        Price, Angela
        Phone: (407) 650-7634
        Email: alprice@nemours.org
IN
  • Riley Hospital for Children Indiana University Medical Center (Pediatric), Indianapolis, IN, 46202
    Contact Information:
        Bendy, Lisa
        Phone: (317) 948-7152
        Email: lbendy@iupui.edu
MI
  • Children's Hospital of Michigan (Pediatric), Detroit, MI, 48201
    Contact Information:
        Van Wagnen, Catherine
        Phone: (313) 745-4737
        Email: cvanwag@med.wayne.edu
NH
  • Dartmouth Hitchcock Medical Center (Adult), Lebanon, NH, 03756
    Contact Information:
        Dorman, Dana
        Phone: (603) 629-8311
        Email: Dana.B.Dorman@hitchcock.org
NY
  • SUNY Upstate Medical University (Pediatric), Syracuse, NY, 13210
    Contact Information:
        Lindner, Donna
        Phone: (315) 464-7525
        Email: lindnerd@upstate.edu
OH
  • University Hospitals Case Medical Center/Rainbow Babies and Children's Hospital (Pediatric), Cleveland, OH, 44106
    Contact Information:
        Ksenich, Roberta (Bobbi)
        Phone: (216) 844-5733
        Email: Roberta.Ksenich@UHHospitals.org
SC
  • Medical University of South Carolina (Adult), Charleston, SC, 29425
    Contact Information:
        Warden, Ashley
        Phone: (843) 792-4349
        Email: jonesash@musc.edu
WI
  • Children's Hospital of Wisconsin Froedtert & Medical College of Wisconsin (Pediatric), Milwaukee, WI, 53201
    Contact Information:
        Kump, Theresa
        Phone: (414) 337-7144
        Email: tkump@mcw.edu
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