Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease
- Conditions
- Cystic Fibrosis
- Interventions
- Registration Number
- NCT00625612
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this trial is to evaluate the safety and effectiveness of one dose strength of Denufosol compared to placebo in patients with CF and a predicted FEV1 of greater than or equal to 75% but less than or equal to 110% predicted.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 466
- Have confirmed diagnosis of cystic fibrosis
- Have FEV1 of greater than or equal to 75% but less than or equal to 110%predicted normal for age, gender and height
- Be able to reproducibly perform spirometry
- Be clinically stable for at least 4 weeks before screening
- Have abnormal renal or liver function
- Have lung transplant
- Unable to discontinue use of hypertonic saline
- Participated in Inspire trial 08-108
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo - 1 Denufosol Tetrasodium (INS37217) Inhalation Solution Denufosol Tetrasodium (INS37217) Inhalation Solution
- Primary Outcome Measures
Name Time Method Change in lung function 48 weeks
- Secondary Outcome Measures
Name Time Method Pulmonary Exacerbation, Antibiotic Use, Incidence of Hospitalization/ER visits, Health resource utilization, Quality of Life 48 weeks
Trial Locations
- Locations (104)
Cystic Fibrosis Institute
🇺🇸Glenview, Illinois, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Children's Healthcare of Atlanta at Scottish Rite
🇺🇸Atlanta, Georgia, United States
Childrens Hospital of Los Angeles
🇺🇸Los Angeles, California, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
University Hospital of Cleveland
🇺🇸Cleveland, Ohio, United States
James Whitcomb RIley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
UCSD Medical Center - Hillcrest & Thornton Hospitals
🇺🇸San Diego, California, United States
Children's Lung Specialists
🇺🇸Las Vegas, Nevada, United States
Children's Health Care
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota - Farview
🇺🇸Minneapolis, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Santiago Reyes, MD
🇺🇸Oklahoma City, Oklahoma, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Phoenix Childrens Hospital
🇺🇸Phoenix, Arizona, United States
USC Cystic Fibrosis Center
🇺🇸Los Angeles, California, United States
Children's Memorial Hospital
🇺🇸Chicago, Illinois, United States
Sanford University
🇺🇸Palo Alto, California, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Cystic Fibrosis Center of Schneider Children's Hospital
🇺🇸Great Neck, New York, United States
St. Vincent's Catholic Medical Center
🇺🇸New York, New York, United States
Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States
St. Alexius Medical Center
🇺🇸Bismark, North Dakota, United States
Children's Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
Columbus Children's Hospital
🇺🇸Columbus, Ohio, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
New York Medical College
🇺🇸Hawthorne, New York, United States
The Children's Medical Center of Dayton
🇺🇸Dayton, Ohio, United States
Austin Children's Chest Associates
🇺🇸Austin, Texas, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
Sanford Childrens' Specialty Clinic
🇺🇸Sioux Falls, South Dakota, United States
Dallas Cystic Fibrosis Center
🇺🇸Dallas, Texas, United States
East Tennesse Children's Hospital - Pediatric Pulmonary and Respiratory Care
🇺🇸Knoxville, Tennessee, United States
The Childrens Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Childrens Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Naval Medical Center Portsmouth
🇺🇸Portsmouth, Virginia, United States
Pediatric Pulmonary Clinic
🇺🇸Richmond, Virginia, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Respiratory Medicine
🇦🇺Parkville, Victoria, Australia
Prince Charles Hospital
🇦🇺Chermside, Queensland, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
University of Toronto
🇨🇦Toronto, Ontario, Canada
The Children's Hospital of Westmead
🇦🇺Westmead, Australia
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia
McMaster University
🇨🇦Hamilton, Ontario, Canada
A. Lyttle Research COmpany
🇨🇦London, Ontario, Canada
Centre Mere-Enfant du CHUL
🇨🇦Montreal, Quebec, Canada
Green Lane Clinical Centre (NZ)
🇳🇿Auckland, New Zealand
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Saint Louis University
🇺🇸St. Louis, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
University of Rochester
🇺🇸Rochester, New York, United States
Albany Medical College
🇺🇸Albany, New York, United States
Capital Allergy & Respiratory Disease Center
🇺🇸Sacramento, California, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Pediatric Breathing Disorders
🇺🇸Anchorage, Alaska, United States
Kaiser Permanente Medical Center
🇺🇸Oakland, California, United States
Bay Area Pediatric Pulmonary
🇺🇸Oakland, California, United States
University of Arizona/Arizona Health Sciences
🇺🇸Tucson, Arizona, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
UCSD Medical Center - Hillcrest and Thornton Hospitals
🇺🇸San Diego, California, United States
Pediatric Diagnostic Center
🇺🇸Ventura, California, United States
Yale School of Medicine
🇺🇸New Haven, Connecticut, United States
Shands at University of Florida
🇺🇸Gainesville, Florida, United States
Alfred I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Nemours Children's Clinic
🇺🇸Pensacola, Florida, United States
Pediatric Pulmonary Associates
🇺🇸St. Petersburg, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
St. Mary's Medical Center
🇺🇸West Palm Beach, Florida, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Via Christa Research
🇺🇸Wichita, Kansas, United States
Tulane University Medical Center
🇺🇸New Orleans, Louisiana, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Spectrum Health Hospitals
🇺🇸Grand Rapids, Michigan, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Childrens Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Saint Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
The Respiratory Center for Children
🇺🇸Morristown, New Jersey, United States
PennState Milton S Hershey Med
🇺🇸Hershey, Pennsylvania, United States
Toledo Children's Hospital
🇺🇸Toledo, Ohio, United States
Children's Hospital of the King's Daughters
🇺🇸Norfolk, Virginia, United States
John Hunter Hospital - Adults
🇦🇺New Lambton, New South Wales, Australia
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Westmead Adults
🇦🇺Westmead, New South Wales, Australia
Royal Brisbane Children's Hospital
🇦🇺Herston, Queensland, Australia
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
University of Calgary, Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
Sire Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Eastern Health
🇨🇦St. Johns, Newfoundland and Labrador, Canada
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
British Columbia Children's Hospital
🇨🇦Vancouver, British Columbia, Canada
University of Wisconsin School of Medicine and Pulbic Health
🇺🇸Madison, Wisconsin, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada