Clinical trial NCT00625612: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cystic Fibrosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-02-28
Enrollment: 466
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in lung function
timeFrame: 48 weeks
Secondary outcomes:
measure: Pulmonary Exacerbation, Antibiotic Use, Incidence of Hospitalization/ER visits, Health resource utilization, Quality of Life
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Anchorage
country: United States
facility: Pediatric Breathing Disorders
state: Alaska
city: Phoenix
country: United States
facility: Phoenix Childrens Hospital
state: Arizona
city: Tucson
country: United States
facility: University of Arizona/Arizona Health Sciences
state: Arizona
city: Los Angeles
country: United States
facility: Childrens Hospital of Los Angeles
state: California
city: Los Angeles
country: United States
facility: USC Cystic Fibrosis Center
state: California
city: Oakland
country: United States
facility: Bay Area Pediatric Pulmonary
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Palo Alto
country: United States
facility: Sanford University
state: California
city: Sacramento
country: United States
facility: Capital Allergy & Respiratory Disease Center
state: California
city: San Diego
country: United States
facility: UCSD Medical Center - Hillcrest & Thornton Hospitals
state: California
city: San Diego
country: United States
facility: UCSD Medical Center - Hillcrest and Thornton Hospitals
state: California
city: Ventura
country: United States
facility: Pediatric Diagnostic Center
state: California
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Wilmington
country: United States
facility: Alfred I. duPont Hospital for Children
state: Delaware
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Gainesville
country: United States
facility: Shands at University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
city: Pensacola
country: United States
facility: Nemours Children's Clinic
state: Florida
city: St. Petersburg
country: United States
facility: Pediatric Pulmonary Associates
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: West Palm Beach
country: United States
facility: St. Mary's Medical Center
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta at Scottish Rite
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
city: Glenview
country: United States
facility: Cystic Fibrosis Institute
state: Illinois
city: Indianapolis
country: United States
facility: James Whitcomb RIley Hospital for Children
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Wichita
country: United States
facility: Via Christa Research
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University Medical Center
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals
state: Michigan
city: Minneapolis
country: United States
facility: Children's Health Care
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota - Farview
state: Minnesota
city: Kansas City
country: United States
facility: Childrens Mercy Hospital
state: Missouri
city: St. Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: Children's Lung Specialists
state: Nevada
city: Livingston
country: United States
facility: Saint Barnabas Medical Center
state: New Jersey
city: Long Branch
country: United States
facility: Monmouth Medical Center
state: New Jersey
city: Morristown
country: United States
facility: The Respiratory Center for Children
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Great Neck
country: United States
facility: Cystic Fibrosis Center of Schneider Children's Hospital
state: New York
city: Hawthorne
country: United States
facility: New York Medical College
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: St. Vincent's Catholic Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Bismark
country: United States
facility: St. Alexius Medical Center
state: North Dakota
city: Akron
country: United States
facility: Children's Hospital Medical Center of Akron
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospital of Cleveland
state: Ohio
city: Columbus
country: United States
facility: Columbus Children's Hospital
state: Ohio
city: Dayton
country: United States
facility: The Children's Medical Center of Dayton
state: Ohio
city: Toledo
country: United States
facility: Toledo Children's Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Santiago Reyes, MD
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Hershey
country: United States
facility: PennState Milton S Hershey Med
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Childrens Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Childrens Hospital of Pittsburgh
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Childrens' Specialty Clinic
state: South Dakota
city: Knoxville
country: United States
facility: East Tennesse Children's Hospital - Pediatric Pulmonary and Respiratory Care
state: Tennessee
city: Austin
country: United States
facility: Austin Children's Chest Associates
state: Texas
city: Dallas
country: United States
facility: Dallas Cystic Fibrosis Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Norfolk
country: United States
facility: Children's Hospital of the King's Daughters
state: Virginia
city: Portsmouth
country: United States
facility: Naval Medical Center Portsmouth
state: Virginia
city: Richmond
country: United States
facility: Pediatric Pulmonary Clinic
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Pulbic Health
state: Wisconsin
city: New Lambton
country: Australia
facility: John Hunter Hospital - Adults
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Adults
state: New South Wales
city: Chermside
country: Australia
facility: Prince Charles Hospital
state: Queensland
city: Herston
country: Australia
facility: Royal Brisbane Children's Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: Respiratory Medicine
state: Victoria
city: Nedlands
country: Australia
facility: Sire Charles Gairdner Hospital
state: Western Australia
city: Perth
country: Australia
facility: Princess Margaret Hospital for Children
state: Western Australia
city: Westmead
country: Australia
facility: The Children's Hospital of Westmead
city: Calgary
country: Canada
facility: University of Calgary, Alberta Children's Hospital
state: Alberta
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: British Columbia
city: St. John's
country: Canada
facility: Eastern Health
state: Newfoundland and Labrador
city: St. Johns
country: Canada
facility: Eastern Health
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: London
country: Canada
facility: A. Lyttle Research COmpany
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
city: Montreal
country: Canada
facility: Centre Mere-Enfant du CHUL
state: Quebec
city: Auckland
country: New Zealand
facility: Green Lane Clinical Centre (NZ)
Study officials:
affiliation: Toronto, Canada
name: Felix Ratjen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.