87
Participants
Start Date
March 31, 2013
Primary Completion Date
November 30, 2014
Study Completion Date
November 30, 2014
Vancomycin hydrochloride inhalation powder
There will be two treatment cohorts in this study, each comprised of 40 randomized (1:1 active to placebo) and treated patients (adults ≥18 and children ≥12 years of age). In Cohort 1, patients will be enrolled and randomized to receive the 32 mg dose of AeroVanc bid or placebo bid. Prior to starting enrollment in Cohort 2, a safety evaluation will be carried out by the Data Monitoring Committee (DMC) based on treatment data from the first 20 patients in Cohort 1. Subject to the Sponsor's written communication of the DMC's opinion of acceptable safety, the dose for the active arm in Cohort 2 will be escalated to 64 mg bid. Optionally, the active arm for Cohort 2 may also be kept the same (32 mg bid), or reduced to 16 mg bid, depending on the outcome of the DMC's safety evaluation.
Placebo inhalation powder
Columbia University Medical Center, New York
Hofstra North Shore - Long Island Jewish School of Medicine, New Hyde Park
Children's Hospital of Pittsburgh of UPMC, Pittsburgh
University of Pennsylvania, Philadelphia
University of North Carolina, Chapel Hill
Duke University Medical Center, Durham
Medical University of South Carolina, Charleston
Central Florida Pulmonary Group, Orlando
Nemours Children's Clinic and Hospital, Orlando
Joe DiMaggio Children's Hospital, Hollywood
University of Miami - Miller School of Medicine, Miami
New Lung Associates, PA; Lung Transplant, Adult Cystic Fibrosis, and the Center for Advanced Lung Diseases, Tampa General Hospital, Tampa
Pulmonary Associates of Mobile, Mobile
Vanderbilt University Medical Center, Nashville
University of Louisville, Louisville
University of Kentucky Cystic Fibrosis Clinic, Lexington
Nationwide Children's Hospital, Columbus
Rainbow Babies and Children's Hospital / University Hospitals Case Medical Center, Cleveland
The Children's Medical Center of Dayton, Dayton
Wayne State University, Harper Hospital, Children's Hospital of Michigan, Detroit
The Cystic Fibrosis Center of Chicago, Glenview
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago
Northwestern University Feinberg School of Medicine, Chicago
Washington University School of Medicine, St Louis
University of Kansas Medical Center, Kansas City
University of Arkansas for Medical Science, Little Rock
Santiago Reyes, MD, Oklahoma City
University of Texas Southwestern Medical Center, Dallas
University of Texas Health Science Center at Tyler, Tyler
Baylor College of Medicine and Texas Children's Hospital, Houston
Dell Children's Medical Center of Central Texas, Austin
National Jewish Health, Denver
University of Utah, Intermountain Cystic Fibrosis Center, Salt Lake City
Children's Hospital Los Angeles, Division of Pediatric Pulmonology, Los Angeles
University of Washington Medical Center, Seattle
Massachusetts General Hospital Pediatric Cystic Fibrosis Center, Boston
Boston Children's Hospital Cystic Fibrosis Center, Boston
Rutgers Robert Wood Johnson Medical School, New Brunswick
Synteract, Inc.
INDUSTRY
Cystic Fibrosis Foundation
OTHER
Savara Inc.
INDUSTRY