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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
466

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in lung function
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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