CFF - Home Monitoring of Lung Function

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Clinical Research Information Sheet

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.

University of Alabama at Birmingham (Adult), Birmingham, AL, 35294
Contact Information:
    Hathorne, Heather
    Phone: (205) 638-9568
    Email: hhathorne@peds.uab.edu

Stanford University (Adult), Palo Alto, CA, 94305
Contact Information:
    Dunn, Colleen
    Phone: (650) 736-0388
    Email: cedunn@stanford.edu

Children's Hospital Colorado (Pediatric), Aurora, CO, 80045
Contact Information:
    Pardee, Churee
    Phone: (720) 777-6162
    Email: chureeporn.pardee@childrenscolorado.org
National Jewish Health (Adult), Denver, CO, 80206
Contact Information:
    Jones, Marion
    Phone: (303) 398-1265
    Email: jonesm@njhealth.org

University of Iowa (Adult), Iowa City, IA, 52242
Contact Information:
    Teresi, Mary
    Phone: (319) 384-7546
    Email: mary-teresi@uiowa.edu

Northwestern University (Adult), Chicago, IL, 60611
Contact Information:
    Singh, Noopur
    Phone: (312) 227-6861
    Email: nosingh@luriechildrens.org

Johns Hopkins Adult CF Program (Adult), Baltimore, MD, 21205
Contact Information:
    Callahan, Karen
    Phone: (443) 287-8983
    Email: kcallah1@jhmi.edu

The Minnesota Cystic Fibrosis Center (Adult), Minneapolis, MN, 55455
Contact Information:
    Grover, Patricia
    Phone: (612) 626-7425
    Email: Grove026@umn.edu

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

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:
    Johnson, Mary Terri
    Phone: (614) 722-4766
    Email: Terri.Johnson@nationwidechildrens.org

University of Pittsburgh School of Medicine (Adult), Pittsburgh, PA, 15213
Contact Information:
    Hartigan, Elizabeth
    Phone: (412) 692-7060
    Email: elizabeth.hartigan@chp.edu

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:
    Wolfstone, Alycia
    Phone: (206) 685-3995
    Email: aewolf@u.washington.edu