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
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
United States, Australia, Canada, New Zealand,
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 |
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