Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease
NCT ID: NCT00625612
Last Updated: 2015-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
466 participants
INTERVENTIONAL
2008-02-29
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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2
Placebo
Placebo - 0.9% w/v sodium chloride solution, three times daily for twelve months.
1
Denufosol Tetrasodium (INS37217) Inhalation Solution
Denufosol Tetrasodium (INS37217) Inhalation Solution
Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution, Denufosol 60 mg is administered as an inhalation solution, three times daily for twelve months.
Interventions
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Denufosol Tetrasodium (INS37217) Inhalation Solution
Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution, Denufosol 60 mg is administered as an inhalation solution, three times daily for twelve months.
Placebo
Placebo - 0.9% w/v sodium chloride solution, three times daily for twelve months.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Have lung transplant
* Unable to discontinue use of hypertonic saline
* Participated in Inspire trial 08-108
5 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Felix Ratjen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Toronto, Canada
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Pediatric Breathing Disorders
Anchorage, Alaska, United States
Phoenix Childrens Hospital
Phoenix, Arizona, United States
University of Arizona/Arizona Health Sciences
Tucson, Arizona, United States
Childrens Hospital of Los Angeles
Los Angeles, California, United States
USC Cystic Fibrosis Center
Los Angeles, California, United States
Bay Area Pediatric Pulmonary
Oakland, California, United States
Kaiser Permanente Medical Center
Oakland, California, United States
Children's Hospital of Orange County
Orange, California, United States
Sanford University
Palo Alto, California, United States
Capital Allergy & Respiratory Disease Center
Sacramento, California, United States
UCSD Medical Center - Hillcrest & Thornton Hospitals
San Diego, 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
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Shands at University of Florida
Gainesville, Florida, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
Nemours Children's Clinic
Pensacola, Florida, United States
Pediatric Pulmonary Associates
St. Petersburg, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
St. Mary's Medical Center
West Palm Beach, Florida, United States
Emory University
Atlanta, Georgia, United States
Children's Healthcare of Atlanta at Scottish Rite
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Cystic Fibrosis Institute
Glenview, Illinois, United States
James Whitcomb RIley Hospital for Children
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Via Christa Research
Wichita, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Tulane University Medical Center
New Orleans, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Spectrum Health Hospitals
Grand Rapids, Michigan, United States
Children's Health Care
Minneapolis, Minnesota, United States
University of Minnesota - Farview
Minneapolis, Minnesota, United States
Childrens Mercy Hospital
Kansas City, Missouri, United States
Saint Louis University
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Children's Lung Specialists
Las Vegas, Nevada, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
The Respiratory Center for Children
Morristown, New Jersey, United States
Albany Medical College
Albany, New York, United States
Cystic Fibrosis Center of Schneider Children's Hospital
Great Neck, New York, United States
New York Medical College
Hawthorne, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
St. Vincent's Catholic Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
St. Alexius Medical Center
Bismarck, North Dakota, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
University Hospital of Cleveland
Cleveland, Ohio, United States
Columbus Children's Hospital
Columbus, Ohio, United States
The Children's Medical Center of Dayton
Dayton, Ohio, United States
Toledo Children's Hospital
Toledo, Ohio, United States
Santiago Reyes, MD
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
PennState Milton S Hershey Med
Hershey, Pennsylvania, 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
Sanford Childrens' Specialty Clinic
Sioux Falls, South Dakota, United States
East Tennesse Children's Hospital - Pediatric Pulmonary and Respiratory Care
Knoxville, Tennessee, United States
Austin Children's Chest Associates
Austin, Texas, United States
Dallas Cystic Fibrosis Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, 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
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
University of Wisconsin School of Medicine and Pulbic Health
Madison, Wisconsin, United States
John Hunter Hospital - Adults
New Lambton, New South Wales, Australia
Westmead Adults
Westmead, New South Wales, Australia
Prince Charles Hospital
Chermside, Queensland, Australia
Royal Brisbane Children's Hospital
Herston, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Respiratory Medicine
Parkville, Victoria, Australia
Sire Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
The Children's Hospital of Westmead
Westmead, , Australia
University of Calgary, Alberta Children's Hospital
Calgary, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
Eastern Health
St. John's, Newfoundland and Labrador, Canada
Eastern Health
St. John's, Newfoundland and Labrador, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
McMaster University
Hamilton, Ontario, Canada
A. Lyttle Research COmpany
London, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
University of Toronto
Toronto, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Centre Mere-Enfant du CHUL
Montreal, Quebec, Canada
Green Lane Clinical Centre (NZ)
Auckland, , New Zealand
Countries
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References
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Ratjen F, Durham T, Navratil T, Schaberg A, Accurso FJ, Wainwright C, Barnes M, Moss RB; TIGER-2 Study Investigator Group. Long term effects of denufosol tetrasodium in patients with cystic fibrosis. J Cyst Fibros. 2012 Dec;11(6):539-49. doi: 10.1016/j.jcf.2012.05.003. Epub 2012 Jun 8.
Other Identifiers
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08-110
Identifier Type: -
Identifier Source: secondary_id
P08640
Identifier Type: -
Identifier Source: org_study_id
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