Page Title
Clinical Trial Finder
Anti-Infective Enrolling
Study to evaluate inhaled RSP-1502 in adults with cystic fibrosis and Pseudomonas aeruginosa (Respirion RESPIR-102 )
This study will look at the safety of inhaled RSP-1502, a drug intended to treat infections in the lung. RSP-1502, which includes the antibiotic tobramycin, will be compared to tobramycin alone. The study will measure the drug's safety, how well it works, and how the body processes it. Four doses of RSP-1502 will be tested to find the best dose.
This is a double-blind study so neither the participants nor the study team will know what treatment a particular participant is on. Some participants will receive the study drug, RSP-1502 which includes tobramycin, and some will receive tobramycin alone. There is no placebo used in this study. Researchers will be evaluating the safety of the study drug through monitoring participant's changes in health.
This study may require blood draws, lung function tests, sputum collection, an assessment of side effects, and completion of questionnaires.
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
40 to 90%
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
History of P. aeruginosa-positive sputum cultures following treatment, with at least 50% positive in the year preceding screening.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
No -
Length of Participation:
28 days -
Number of Study Visits:
4
Additional Information
-
Phase: ?more info
Phase One -
Study Sponsor: ?more info
Respirion -
Study Drugs:
Study Sites
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Enrolling
Arizona
Tucson Cystic Fibrosis Center, Tucson, AZ 85724
Contact
Elizabeth Ryan
Phone: +1 (520) 850-8688
Email: elizabethryan@arizona.edu
-
Enrolling
California
Stanford University Medical Center, Palo Alto, CA 94304
Contact
Jacquelyn Spano
Phone: +1 (650) 721-1132
Email: jmzirbes@stanford.edu
-
Enrolling Soon
California
Center for Cystic Fibrosis at Keck Medical Center of USC, Los Angeles, CA 90033
Contact
Lynn Fukushima
Phone: +1 (323) 409-5383
Email: lynn.fukushima@med.usc.edu
-
Enrolling
Georgia
Augusta University, Augusta, GA 30912
Contact
Heidi Stapp
Phone: +1 (706) 721-7699
Email: hstapp@augusta.edu
-
Enrolling Soon
Louisiana
Tulane University, Metairie, LA 70006
Contact
Carol Rockwell
Phone: +1 (504) 988-2325
Email: crockwell@tulane.edu
-
Enrolling
Minnesota
The Minnesota Cystic Fibrosis Center, Minneapolis, MN 55455
Contact
Participant Contact University of Minnesota
Phone: +1
Email: cftrials@umn.edu
-
Enrolling
Missouri
Washington University School of Medicine, St. Louis, MO 63110
Contact
Irma Bauer
Phone: +1 (314) 747-2940
Email: irmabauer@wustl.edu
-
Enrolling
New York
Columbia University Cystic Fibrosis Program, New York, NY 10032
Contact
Emily DiMango
Phone: +1 (212) 305-0290
Email: ead3@cumc.columbia.edu
-
Enrolling
Ohio
Nationwide Children's Hospital, Columbus, OH 43205
Contact
Diana Gilmore
Phone: +1 (614) 722-4752
Email: diana.gilmore@nationwidechildrens.org
-
Enrolling
Ohio
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44106
Contact
Primary RC & Participant Contact General Contact
Phone: +1
Email: RainbowCFResearch@UHhospitals.org
-
Enrolling
Pennsylvania
University of Pennsylvania, Philadelphia, PA 19104
Contact
Melissa Molter
Phone: +1 (215) 662-3116
Email: melissa.molter@pennmedicine.upenn.edu
-
Enrolling
Texas
Dell Children's Medical Center of Central Texas, Austin, TX 78723
Contact
Kristina "Tina" Adrean
Phone: +1 (512) 324-9999
Email: Kadrean@ascension.org
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
40 to 90% -
Pseudomonas Status:
Positive Respiratory Cultures Required
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
History of P. aeruginosa-positive sputum cultures following treatment, with at least 50% positive in the year preceding screening.
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