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Study of SPI-1005 in people with CF ages 18 and older (Sound Pharma SPI-3005-501.2)
This study will test the safety and tolerability of SPI-1005, a drug intended to prevent and treat hearing loss caused by aminoglycosides.
This study will be randomized and placebo-controlled. This means that some participants will receive SPI-1005 and some will receive a placebo. Participants who receive SPI-1005 will receive one of three dose levels. Researchers will measure safety and tolerability by monitoring for adverse events. They will also track how the body processes SPI-1005 by measuring symptoms of hearing loss and how much of the drug is in the blood.
This study may require hearing tests, lung function tests, blood draws, and/or other measurements.
Study Design
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Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
Yes -
Length of Participation:
49 days -
Number of Study Visits:
6
Additional Information
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Phase: ?more info
Phase Two -
Study Sponsor: ?more info
Sound Pharma -
Study Drugs:
Other Primary Eligibility Criteria
The participant must be about to receive IV tobramycin (or within 48 hours of starting it) for the treatment of an acute pulmonary exacerbation.
Study Sites
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Enrolling
Florida
University of Miami, Miami, FL 33136
Contact
Eliana Mendes
Phone: +1 (305) 243-2568
Email: emendes@med.miami.edu
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Enrolling Soon
Maryland
Johns Hopkins University, Baltimore, MD 21205
Contact
Britany Zeglin
Phone: +1 (443) 287-8983
Email: bzeglin1@jhmi.edu
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Enrolling Soon
Pennsylvania
University of Pennsylvania, Philadelphia, PA 19104
Contact
Victoria Fleck
Phone: +1 (215) 662-3115
Email: Victoria.Fleck@uphs.upenn.edu
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Enrolling Soon
South Carolina
Medical University of South Carolina, Charleston, SC 29425
Contact
Ashley Warden
Phone: +1 (843) 792-4349
Email: jonesash@musc.edu
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Enrolling Soon
Texas
University of Texas Southwestern, Dallas, TX 75390
Contact
Ashley Keller
Phone: +1 (214) 648-2817
Email: Ashley.Keller@UTSouthwestern.edu
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Enrolling Soon
Washington
University of Washington Medical Center, Seattle, WA 98195
Contact
Teresa Gambol
Phone: +1 (206) 543-7382
Email: TGambol@medicine.washington.edu
Clinical Studies 101
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Questions to Ask When Considering a Specific Trial
Clinical trials that test potential drugs and therapies in people with cystic fibrosis are a major part of CF research. They take place at Cystic Fibrosis Foundation-accredited care centers all over the United States and enroll people with CF of all ages.
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Patient Safety Is a Priority
Nothing is more important than patient safety in developing new treatments for cystic fibrosis. The U.S. government requires that all clinical trials are supervised for safety, and the Cystic Fibrosis Foundation adds additional measures to protect study volunteers.
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How Do Clinical Trials Work
Each clinical trial has a study sponsor and a protocol. Potential drugs must move through four well-defined phases of testing in patients.
