Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00625612
First received: February 12, 2008
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change in lung function [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pulmonary Exacerbation, Antibiotic Use, Incidence of Hospitalization/ER visits, Health resource utilization, Quality of Life [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 466
Study Start Date: February 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2 Drug: Placebo
Placebo - 0.9% w/v sodium chloride solution, three times daily for twelve months.
Experimental: 1
Denufosol Tetrasodium (INS37217) Inhalation Solution
Drug: 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.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Have abnormal renal or liver function
  • Have lung transplant
  • Unable to discontinue use of hypertonic saline
  • Participated in Inspire trial 08-108
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625612

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, Alaska
Pediatric Breathing Disorders
Anchorage, Alaska, United States, 99508
United States, Arizona
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
University of Arizona/Arizona Health Sciences
Tucson, Arizona, United States, 85724
United States, California
Childrens Hospital of Los Angeles
Los Angeles, California, United States, 90027
USC Cystic Fibrosis Center
Los Angeles, California, United States, 90033
Kaiser Permanente Medical Center
Oakland, California, United States, 94611
Bay Area Pediatric Pulmonary
Oakland, California, United States, 94609
Children's Hospital of Orange County
Orange, California, United States, 92868
Sanford University
Palo Alto, California, United States, 94304
Capital Allergy & Respiratory Disease Center
Sacramento, California, United States, 95819
UCSD Medical Center - Hillcrest & Thornton Hospitals
San Diego, California, United States, 92103
UCSD Medical Center - Hillcrest and Thornton Hospitals
San Diego, California, United States, 92103
Pediatric Diagnostic Center
Ventura, California, United States, 93003
United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06520
United States, Delaware
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
Shands at University of Florida
Gainesville, Florida, United States, 32610
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Nemours Children's Clinic
Pensacola, Florida, United States, 32504
Pediatric Pulmonary Associates
St. Petersburg, Florida, United States, 33701
Tampa General Hospital
Tampa, Florida, United States, 33606
St. Mary's Medical Center
West Palm Beach, Florida, United States, 33407
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Children's Healthcare of Atlanta at Scottish Rite
Atlanta, Georgia, United States, 30342
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
Cystic Fibrosis Institute
Glenview, Illinois, United States, 60025
United States, Indiana
James Whitcomb RIley Hospital for Children
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Via Christa Research
Wichita, Kansas, United States, 67214
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Louisiana
Tulane University Medical Center
New Orleans, Louisiana, United States, 70112
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Spectrum Health Hospitals
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
University of Minnesota - Farview
Minneapolis, Minnesota, United States, 55455
Children's Health Care
Minneapolis, Minnesota, United States, 55404
United States, Missouri
Childrens Mercy Hospital
Kansas City, Missouri, United States, 64108
Saint Louis University
St. Louis, Missouri, United States, 63104
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Nevada
Children's Lung Specialists
Las Vegas, Nevada, United States, 83107
United States, New Jersey
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740
The Respiratory Center for Children
Morristown, New Jersey, United States, 07960
United States, New York
Albany Medical College
Albany, New York, United States, 12208
Cystic Fibrosis Center of Schneider Children's Hospital
Great Neck, New York, United States, 11021
New York Medical College
Hawthorne, New York, United States, 10532
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Columbia University Medical Center
New York, New York, United States, 10032
St. Vincent's Catholic Medical Center
New York, New York, United States, 10011
University of Rochester
Rochester, New York, United States, 14642
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, North Dakota
St. Alexius Medical Center
Bismark, North Dakota, United States, 58501
United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
University Hospital of Cleveland
Cleveland, Ohio, United States, 44106
Columbus Children's Hospital
Columbus, Ohio, United States, 43205
The Children's Medical Center of Dayton
Dayton, Ohio, United States, 45404
Toledo Children's Hospital
Toledo, Ohio, United States, 43606
United States, Oklahoma
Santiago Reyes, MD
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
PennState Milton S Hershey Med
Hershey, Pennsylvania, United States, 17033
The Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, South Dakota
Sanford Childrens' Specialty Clinic
Sioux Falls, South Dakota, United States, 57117
United States, Tennessee
East Tennesse Children's Hospital - Pediatric Pulmonary and Respiratory Care
Knoxville, Tennessee, United States, 37916
United States, Texas
Austin Children's Chest Associates
Austin, Texas, United States, 78723
Dallas Cystic Fibrosis Center
Dallas, Texas, United States, 75235
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States, 23507
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States, 84132
Pediatric Pulmonary Clinic
Richmond, Virginia, United States, 23219
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
University of Wisconsin School of Medicine and Pulbic Health
Madison, Wisconsin, United States, 53792
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Australia, New South Wales
John Hunter Hospital - Adults
New Lambton, New South Wales, Australia, 2305
Westmead Adults
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Royal Brisbane Children's Hospital
Herston, Queensland, Australia, 4029
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Respiratory Medicine
Parkville, Victoria, Australia, 3052
Australia, Western Australia
Sire Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6840
Australia
The Children's Hospital of Westmead
Westmead, Australia, NSW 2145
Canada, Alberta
University of Calgary, Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V64 3V4
St. Paul's Hospital
Vancouver, British Columbia, Canada, V621Y6
Canada, Newfoundland and Labrador
Eastern Health
St. John's, Newfoundland and Labrador, Canada, AIA346
Eastern Health
St. Johns, Newfoundland and Labrador, Canada, AIA 3V6
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N 325
A. Lyttle Research COmpany
London, Ontario, Canada, N6A1V2
Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
University of Toronto
Toronto, Ontario, Canada, M5B 1W8
Hospital for Sick Children
Toronto, Ontario, Canada, MSG 1XB
Canada, Quebec
Centre Mere-Enfant du CHUL
Montreal, Quebec, Canada, HZW 1T7
New Zealand
Green Lane Clinical Centre (NZ)
Auckland, New Zealand
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Felix Ratjen, MD, PhD Toronto, Canada
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00625612     History of Changes
Other Study ID Numbers: P08640, 08-110
Study First Received: February 12, 2008
Last Updated: October 29, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Lung Diseases
Pancreatic Diseases
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014