Study of Denufosol Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease

Last updated: October 9, 2015
Sponsor: Merck Sharp & Dohme Corp.
Overall Status: Completed

Phase

3

Condition

Cystic Fibrosis

Scar Tissue

Lung Injury

Treatment

denufosol tetrasodium (INS37217) Inhalation Solution

Placebo - 0.9% w/v sodium chloride solution

Clinical Study ID

NCT00357279
08-108
  • Ages > 5
  • All Genders

Study Summary

The purpose of this trial is to evaluate the safety and effectiveness of a one dose strength of denufosol compared to placebo in patients with mild CF lung disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have confirmed diagnosis of cystic fibrosis

  • Have FEV1 of greater than or equal to 75% of predicted normal for age, gender, andheight

  • Be able to reproducibly perform spirometry maneuvers

  • Be clinically stable for at least 4 weeks prior to screening

Exclusion

Exclusion Criteria:

  • Have abnormal renal or liver function

  • Have chest x-ray at screening suggesting clinically significant active pulmonarydisease

  • Be colonized with Burkholderia cepacia

  • Have had a lung transplant

Study Design

Total Participants: 352
Treatment Group(s): 2
Primary Treatment: denufosol tetrasodium (INS37217) Inhalation Solution
Phase: 3
Study Start date:
July 01, 2006
Estimated Completion Date:
September 30, 2008

Connect with a study center

  • British Columbia's Children's Hospital

    Vancouver, British Columbia V6H-3V4
    Canada

    Site Not Available

  • Queen Elizabeth II Health Sciences Center

    Halifax, Nova Scotia B3H 3A7
    Canada

    Site Not Available

  • Children's Hospital

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Providence Alaska Medical Center

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Phoenix Children's Hospital

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Childrens Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Site Not Available

  • Children'a Hospital and Research Center at Oakland

    Oakland, California 94609
    United States

    Site Not Available

  • Children's Hospital of Orange County

    Orange, California 92868
    United States

    Site Not Available

  • Capital Allergy and Respiratory Disease Center

    Roseville, California 95661
    United States

    Site Not Available

  • Capital Allergy and Respiratory Disease Center

    Sacramento, California 95819
    United States

    Site Not Available

  • Stanford University Hospital and Clinics

    Stanford, California 94305-5236
    United States

    Site Not Available

  • The Children's Hospital

    Denver, Colorado 80218
    United States

    Site Not Available

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Yale School of Medicine

    New Haven, Connecticut 06520-8064
    United States

    Site Not Available

  • Alfred I. duPont Hospital for Children

    Wilmington, Delaware 19803
    United States

    Site Not Available

  • Shands at the University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Nemours Children's Clinic

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Miami Children's Hospital

    Miami, Florida 33155
    United States

    Site Not Available

  • Nemours Children's Clinic

    Orlando, Florida 32806
    United States

    Site Not Available

  • Emory Cystic Fibrosis Center

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Children's Memorial Hospital

    Chicago, Illinois 60614
    United States

    Site Not Available

  • Chicago CF Care Specialists/CFI

    Glenview, Illinois 60025
    United States

    Site Not Available

  • Loyola University Medical Center Outpatient Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Oakbrook Terrace Medical Center

    Oakbrook Terrace, Illinois 60181
    United States

    Site Not Available

  • James Whitcomb Riley Hospital for Children

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242-1083
    United States

    Site Not Available

  • Via Christi Specialty Clinics/CR Clinic

    Wichita, Kansas 67214
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40536-0284
    United States

    Site Not Available

  • Louisiana State University Health Sciences Center

    Shreveport, Louisiana 71130
    United States

    Site Not Available

  • Maine Medical Center

    Portland, Maine 04102
    United States

    Site Not Available

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Michigan Medical PC

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • Univeristy of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Cardinal Glennon Children's Medical Center

    St. Louis, Missouri 63104
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Childrens Lung Specialists, LTD

    Las Vegas, Nevada 89107
    United States

    Site Not Available

  • Saint Barnabas Ambulatory Care Center

    Livingston, New Jersey 07039
    United States

    Site Not Available

  • The Respiratory Center for Children, Morristown Memorial Hospital

    Morristown, New Jersey 07962
    United States

    Site Not Available

  • Women & Children's Hospital of Buffalo

    Buffalo, New York 14222
    United States

    Site Not Available

  • Irving Goldman Family Care Center

    Great Neck, New York 11021
    United States

    Site Not Available

  • Westchester Medical Center and New York Medical College

    Hawthorne, New York 10532
    United States

    Site Not Available

  • The Cystic Fibrosis Center St. Vincent's Hospital, Manhattan

    New York, New York 10011
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14642
    United States

    Site Not Available

  • SUNY Upstate Medical University Hospital

    Syracuse, New York 13210
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • University Hospitals of Cleveland

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Santiago Reyes

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • PHH Cystic Fibrosis Center

    Harrisburg, Pennsylvania 17110
    United States

    Site Not Available

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • The Childrens Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Pediatric Pulmonary Associates

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • Children's Medical Center Dallas, Dallas Cystic Fibrosis Center

    Dallas, Texas 75235
    United States

    Site Not Available

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Alamo Clinical Research Associates

    San Antonio, Texas 78212
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Primary Care Center

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Naval Medical Center Portsmouth

    Portsmouth, Virginia 23708
    United States

    Site Not Available

  • Virginia Commonwealth University Pediatric Pulmonary Clinic

    Richmond, Virginia 23219
    United States

    Site Not Available

  • Childrens Hospital and Regional Medical Center

    Seattle, Washington 98105
    United States

    Site Not Available

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin 53792
    United States

    Site Not Available

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