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Study Name: Home Monitoring of Lung Function
Study Type: Interventional
Intervention Category: Other
Study Sponsor: Goss, Christopher

Funding for this trial has been provided in full or in part by Cystic Fibrosis Foundation Therapeutics, Inc.
Study Phase: Other
Recruitment Status: Recruiting
Study Drug(s): Not Applicable
Number of Participants Being Recruited: 320
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This study will look at monitoring lung function and lung symptoms at home as a method to monitor lung health. Study participants will be randomly assigned to one of two groups: 1) home monitoring, in which spirometry and respiratory symptoms are recorded daily; evaluated by study center and treatment started or 2) CF education on symptoms to look for with lung infections. Home monitoring information will be transmitted by phone modem weekly to the study center and participants in the CF education group will contact the study nurse if they have more respiratory symptoms.
ELIGIBILITY
Age: >= 14 Years
FEV1: >= 26 Percent Predicted
P. aeruginosa status: Not applicable
B. cepacia status: Negative
Other Primary Eligibility Requirements:

Eligible subjects are in a clinically stable state at baseline.
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:
Trial Specific Link on ClinicalTrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT01104402?term=home+monitoring+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.
AL
  • University of Alabama at Birmingham (Adult), Birmingham, AL, 35294
    Contact Information:
        Hathorne, Heather
        Phone: (205) 638-9568
        Email: hhathorne@peds.uab.edu
CA
  • Stanford University (Adult), Palo Alto, CA, 94305
    Contact Information:
        Dunn, Colleen
        Phone: (650) 736-0388
        Email: cedunn@stanford.edu
CO
  • Children's Hospital Colorado (Pediatric), Aurora, CO, 80045
    Contact Information:
        Pardee, Churee
        Phone: (720) 777-6162
        Email: churee.pardee@childrenscolorado.org
  • National Jewish Health (Adult), Denver, CO, 80206
    Contact Information:
        Jones, Marion
        Phone: (303) 398-1265
        Email: jonesm@njhealth.org
IA
  • University of Iowa (Adult), Iowa City, IA, 52242
    Contact Information:
        Teresi, Mary
        Phone: (319) 384-7546
        Email: mary-teresi@uiowa.edu
IL
  • Northwestern University (Adult), Chicago, IL, 60611
    Contact Information:
        Singh, Noopur
        Phone: (312) 227-6861
        Email: nosingh@luriechildrens.org
MD
  • Johns Hopkins Adult CF Program (Adult), Baltimore, MD, 21205
    Contact Information:
        Callahan, Karen
        Phone: (443) 287-8983
        Email: kcallah1@jhmi.edu
MN
  • The Minnesota Cystic Fibrosis Center (Adult), Minneapolis, MN, 55455
    Contact Information:
        Grover, Patricia
        Phone: (612) 626-7425
        Email: Grove026@umn.edu
NC
  • University of North Carolina at Chapel Hill (Adult), Chapel Hill, NC, 27599
    Contact Information:
        Shive, Nadia
        Phone: (919) 966-9198
        Email: nadiab@med.unc.edu
OH
  • Cincinnati Children's Hospital Medical Center (Pediatric), Cincinnati, OH, 45229
    Contact Information:
        Duan, Lorrie
        Phone: (513) 636-7089
        Email: lorrie.duan@cchmc.org
  • University Hospitals Case Medical Center/Rainbow Babies and Children's Hospital (Adult), Cleveland, OH, 44106
    Contact Information:
        Ksenich, Roberta (Bobbi)
        Phone: (216) 844-5733
        Email: Roberta.Ksenich@UHHospitals.org
  • Nationwide Children's Hospital (Adult), Columbus, OH, 43205
    Contact Information:
        Gilmore, Diana
        Phone: (614) 722-4752
        Email: Diana.Gilmore@nationwidechildrens.org
PA
  • University of Pittsburgh School of Medicine (Adult), Pittsburgh, PA, 15213
    Contact Information:
        Hartigan, Elizabeth
        Phone: (412) 692-7060
        Email: elizabeth.hartigan@chp.edu
WA
  • Seattle Children's Hospital (Pediatric), Seattle, WA, 98105
    Contact Information:
        McNamara, Sharon
        Phone: (206) 987-3921 X1
        Email: sharon.mcnamara@seattlechildrens.org
  • University of Washington Medical Center (Adult), Seattle, WA, 98195
    Contact Information:
        Aitken, Moira
        Phone: (206) 543-3166
        Email: moira@u.washington.edu
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