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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Denufosol Tetrasodium (INS37217) Inhalation Solution
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Pediatric Breathing Disorders
  • Phoenix Childrens Hospital
  • University of Arizona/Arizona Health Sciences
  • Childrens Hospital of Los Angeles
  • USC Cystic Fibrosis Center
  • Bay Area Pediatric Pulmonary
  • Kaiser Permanente Medical Center
  • Children's Hospital of Orange County
  • Sanford University
  • Capital Allergy & Respiratory Disease Center
  • UCSD Medical Center - Hillcrest & Thornton Hospitals
  • UCSD Medical Center - Hillcrest and Thornton Hospitals
  • Pediatric Diagnostic Center
  • Yale School of Medicine
  • Alfred I. duPont Hospital for Children
  • Children's National Medical Center
  • Shands at University of Florida
  • Nemours Children's Clinic
  • Nemours Children's Clinic
  • Pediatric Pulmonary Associates
  • Tampa General Hospital
  • St. Mary's Medical Center
  • Emory University
  • Children's Healthcare of Atlanta at Scottish Rite
  • Medical College of Georgia
  • Children's Memorial Hospital
  • Cystic Fibrosis Institute
  • James Whitcomb RIley Hospital for Children
  • University of Kansas Medical Center
  • Via Christa Research
  • University of Kentucky
  • Tulane University Medical Center
  • Maine Medical Center
  • Johns Hopkins University School of Medicine
  • Boston Children's Hospital
  • University of Michigan Health System
  • Spectrum Health Hospitals
  • Children's Health Care
  • University of Minnesota - Farview
  • Childrens Mercy Hospital
  • Saint Louis University
  • University of Nebraska Medical Center
  • Children's Lung Specialists
  • Saint Barnabas Medical Center
  • Monmouth Medical Center
  • The Respiratory Center for Children
  • Albany Medical College
  • Cystic Fibrosis Center of Schneider Children's Hospital
  • New York Medical College
  • Long Island Jewish Medical Center
  • St. Vincent's Catholic Medical Center
  • Columbia University Medical Center
  • University of Rochester
  • SUNY Upstate Medical University Hospital
  • Duke University Medical Center
  • St. Alexius Medical Center
  • Children's Hospital Medical Center of Akron
  • Cincinnati Children's Hospital Medical Center
  • University Hospital of Cleveland
  • Columbus Children's Hospital
  • The Children's Medical Center of Dayton
  • Toledo Children's Hospital
  • Santiago Reyes, MD
  • Oregon Health and Science University
  • PennState Milton S Hershey Med
  • The Childrens Hospital of Philadelphia
  • Childrens Hospital of Pittsburgh
  • Medical University of South Carolina
  • Sanford Childrens' Specialty Clinic
  • East Tennesse Children's Hospital - Pediatric Pulmonary and Respiratory Care
  • Austin Children's Chest Associates
  • Dallas Cystic Fibrosis Center
  • Baylor College of Medicine
  • University of Utah
  • University of Virginia
  • Children's Hospital of the King's Daughters
  • Naval Medical Center Portsmouth
  • Pediatric Pulmonary Clinic
  • West Virginia University
  • University of Wisconsin Hospital and Clinics
  • University of Wisconsin School of Medicine and Pulbic Health
  • John Hunter Hospital - Adults
  • Westmead Adults
  • Prince Charles Hospital
  • Royal Brisbane Children's Hospital
  • Royal Adelaide Hospital
  • Monash Medical Centre
  • Alfred Hospital
  • Respiratory Medicine
  • Sire Charles Gairdner Hospital
  • Princess Margaret Hospital for Children
  • The Children's Hospital of Westmead
  • University of Calgary, Alberta Children's Hospital
  • St. Paul's Hospital
  • British Columbia Children's Hospital
  • Eastern Health
  • Eastern Health
  • Queen Elizabeth II Health Sciences Centre
  • McMaster University
  • A. Lyttle Research COmpany
  • Ottawa Hospital
  • University of Toronto
  • Hospital for Sick Children
  • Centre Mere-Enfant du CHUL
  • Green Lane Clinical Centre (NZ)

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

2

1

Arm Description

Denufosol Tetrasodium (INS37217) Inhalation Solution

Outcomes

Primary Outcome Measures

Change in lung function

Secondary Outcome Measures

Pulmonary Exacerbation, Antibiotic Use, Incidence of Hospitalization/ER visits, Health resource utilization, Quality of Life

Full Information

First Posted
February 12, 2008
Last Updated
October 8, 2015
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00625612
Brief Title
Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
466 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Placebo Comparator
Arm Title
1
Arm Type
Experimental
Arm Description
Denufosol Tetrasodium (INS37217) Inhalation Solution
Intervention Type
Drug
Intervention Name(s)
Denufosol Tetrasodium (INS37217) Inhalation Solution
Intervention Description
Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution, Denufosol 60 mg is administered as an inhalation solution, three times daily for twelve months.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo - 0.9% w/v sodium chloride solution, three times daily for twelve months.
Primary Outcome Measure Information:
Title
Change in lung function
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Pulmonary Exacerbation, Antibiotic Use, Incidence of Hospitalization/ER visits, Health resource utilization, Quality of Life
Time Frame
48 weeks

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
22682898
Citation
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.
Results Reference
derived

Learn more about this trial

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

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