|
|
| 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: |
Recruiting 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. |
| 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. |
| Sponsor Contact Information: |
Koker, Paul
(203) 798-4489
pkoker@rdg.boehringer-ingelheim.com
|
| 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, Osmara
Phone: (520) 891-6767
Email: omolina@arc.arizona.edu
|
| CA |
-
University of California San Diego -Thornton (Adult), La Jolla, CA, 92037
Contact Information:
Kwan, Doris
Phone: (858) 657-7119
Email: dlkwan@ucsd.edu
|
| FL |
-
Nemours Children's Clinic - Jacksonville (Pediatric), Jacksonville, FL, 32207
Contact Information:
DeLuca, Elizabeth
Phone: (904) 697-3804
Email: bdeluca@nemours.org
-
Nemours Children's Clinic - Orlando (Pediatric), Orlando, FL, 32806
Contact Information:
Kesser, Kenneth (Bert)
Phone: (407) 650-7175
Email: bkesser@nemours.org
|
| IN |
-
Riley Hospital for Children Indiana University Medical Center (Pediatric), Indianapolis, IN, 46202
Contact Information:
Richardson, Stacey
Phone: (317) 948-7121
Email: stlyrich@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 (Pediatric), 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:
Kennedy, Emma
Phone: (414) 266-4707
Email: ekennedy@mcw.edu
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