Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease
A Phase 3, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease and FEV1 Greater Than or Equal to 75% Predicted But Less Than or Equal to 110% Predicted
2 other identifiers
interventional
466
4 countries
106
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2008
Typical duration for phase_3
106 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 12, 2008
CompletedFirst Posted
Study publicly available on registry
February 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedNovember 2, 2015
October 1, 2015
2.7 years
February 12, 2008
October 8, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change in lung function
48 weeks
Secondary Outcomes (1)
Pulmonary Exacerbation, Antibiotic Use, Incidence of Hospitalization/ER visits, Health resource utilization, Quality of Life
48 weeks
Study Arms (2)
2
PLACEBO COMPARATOR1
EXPERIMENTALDenufosol Tetrasodium (INS37217) Inhalation Solution
Interventions
Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution, Denufosol 60 mg is administered as an inhalation solution, three times daily for twelve months.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Have abnormal renal or liver function
- Have lung transplant
- Unable to discontinue use of hypertonic saline
- Participated in Inspire trial 08-108
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (106)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Pediatric Breathing Disorders
Anchorage, Alaska, 99508, United States
Phoenix Childrens Hospital
Phoenix, Arizona, 85016, United States
University of Arizona/Arizona Health Sciences
Tucson, Arizona, 85724, United States
Childrens Hospital of Los Angeles
Los Angeles, California, 90027, United States
USC Cystic Fibrosis Center
Los Angeles, California, 90033, United States
Bay Area Pediatric Pulmonary
Oakland, California, 94609, United States
Kaiser Permanente Medical Center
Oakland, California, 94611, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Sanford University
Palo Alto, California, 94304, United States
Capital Allergy & Respiratory Disease Center
Sacramento, California, 95819, United States
UCSD Medical Center - Hillcrest & Thornton Hospitals
San Diego, California, 92103, United States
UCSD Medical Center - Hillcrest and Thornton Hospitals
San Diego, California, 92103, United States
Pediatric Diagnostic Center
Ventura, California, 93003, United States
Yale School of Medicine
New Haven, Connecticut, 06520, United States
Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Shands at University of Florida
Gainesville, Florida, 32610, United States
Nemours Children's Clinic
Jacksonville, Florida, 32207, United States
Nemours Children's Clinic
Pensacola, Florida, 32504, United States
Pediatric Pulmonary Associates
St. Petersburg, Florida, 33701, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
St. Mary's Medical Center
West Palm Beach, Florida, 33407, United States
Emory University
Atlanta, Georgia, 30322, United States
Children's Healthcare of Atlanta at Scottish Rite
Atlanta, Georgia, 30342, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
Children's Memorial Hospital
Chicago, Illinois, 60614, United States
Cystic Fibrosis Institute
Glenview, Illinois, 60025, United States
James Whitcomb RIley Hospital for Children
Indianapolis, Indiana, 46202, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Via Christa Research
Wichita, Kansas, 67214, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Tulane University Medical Center
New Orleans, Louisiana, 70112, United States
Maine Medical Center
Portland, Maine, 04102, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Spectrum Health Hospitals
Grand Rapids, Michigan, 49503, United States
Children's Health Care
Minneapolis, Minnesota, 55404, United States
University of Minnesota - Farview
Minneapolis, Minnesota, 55455, United States
Childrens Mercy Hospital
Kansas City, Missouri, 64108, United States
Saint Louis University
St Louis, Missouri, 63104, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Children's Lung Specialists
Las Vegas, Nevada, 83107, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Monmouth Medical Center
Long Branch, New Jersey, 07740, United States
The Respiratory Center for Children
Morristown, New Jersey, 07960, United States
Albany Medical College
Albany, New York, 12208, United States
Cystic Fibrosis Center of Schneider Children's Hospital
Great Neck, New York, 11021, United States
New York Medical College
Hawthorne, New York, 10532, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
St. Vincent's Catholic Medical Center
New York, New York, 10011, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14642, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
St. Alexius Medical Center
Bismarck, North Dakota, 58501, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
University Hospital of Cleveland
Cleveland, Ohio, 44106, United States
Columbus Children's Hospital
Columbus, Ohio, 43205, United States
The Children's Medical Center of Dayton
Dayton, Ohio, 45404, United States
Toledo Children's Hospital
Toledo, Ohio, 43606, United States
Santiago Reyes, MD
Oklahoma City, Oklahoma, 73112, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
PennState Milton S Hershey Med
Hershey, Pennsylvania, 17033, United States
The Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Sanford Childrens' Specialty Clinic
Sioux Falls, South Dakota, 57117, United States
East Tennesse Children's Hospital - Pediatric Pulmonary and Respiratory Care
Knoxville, Tennessee, 37916, United States
Austin Children's Chest Associates
Austin, Texas, 78723, United States
Dallas Cystic Fibrosis Center
Dallas, Texas, 75235, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84132, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507, United States
Naval Medical Center Portsmouth
Portsmouth, Virginia, 84132, United States
Pediatric Pulmonary Clinic
Richmond, Virginia, 23219, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
University of Wisconsin School of Medicine and Pulbic Health
Madison, Wisconsin, 53792, United States
John Hunter Hospital - Adults
New Lambton, New South Wales, 2305, Australia
Westmead Adults
Westmead, New South Wales, 2145, Australia
Prince Charles Hospital
Chermside, Queensland, 4032, Australia
Royal Brisbane Children's Hospital
Herston, Queensland, 4029, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Respiratory Medicine
Parkville, Victoria, 3052, Australia
Sire Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, 6840, Australia
The Children's Hospital of Westmead
Westmead, NSW 2145, Australia
University of Calgary, Alberta Children's Hospital
Calgary, Alberta, T3B 6A8, Canada
St. Paul's Hospital
Vancouver, British Columbia, V621Y6, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, V64 3V4, Canada
Eastern Health
St. John's, Newfoundland and Labrador, AIA 3V6, Canada
Eastern Health
St. John's, Newfoundland and Labrador, AIA346, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7, Canada
McMaster University
Hamilton, Ontario, L8N 325, Canada
A. Lyttle Research COmpany
London, Ontario, N6A1V2, Canada
Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
University of Toronto
Toronto, Ontario, M5B 1W8, Canada
Hospital for Sick Children
Toronto, Ontario, MSG 1XB, Canada
Centre Mere-Enfant du CHUL
Montreal, Quebec, HZW 1T7, Canada
Green Lane Clinical Centre (NZ)
Auckland, New Zealand
Related Publications (1)
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.
PMID: 22682898DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Felix Ratjen, MD, PhD
Toronto, Canada
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2008
First Posted
February 28, 2008
Study Start
February 1, 2008
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
November 2, 2015
Record last verified: 2015-10