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

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00625612
• Other study ID #: P08640
• Secondary ID: 08-110
• Status: Completed
• Phase: Phase 3
• First received: February 12, 2008
• Last updated: October 8, 2015
• Start date: February 2008
• Est. completion date: October 2010

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 466
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Lung Diseases

Intervention

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.
• Placebo
Placebo - 0.9% w/v sodium chloride solution, three times daily for twelve months.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in lung function		48 weeks	No
Secondary	Pulmonary Exacerbation, Antibiotic Use, Incidence of Hospitalization/ER visits, Health resource utilization, Quality of Life		48 weeks	Yes