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

October 8, 2015 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

466

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in lung function
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Pulmonary Exacerbation, Antibiotic Use, Incidence of Hospitalization/ER visits, Health resource utilization, Quality of Life
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Felix Ratjen, MD, PhD, Toronto, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

February 12, 2008

First Submitted That Met QC Criteria

February 27, 2008

First Posted (Estimate)

February 28, 2008

Study Record Updates

Last Update Posted (Estimate)

November 1, 2015

Last Update Submitted That Met QC Criteria

October 8, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P08640
  • 08-110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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