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| ID | Type | Description | Link |
|---|---|---|---|
| 08-110 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Placebo Comparator |
| |
| 1 | Experimental | Denufosol Tetrasodium (INS37217) Inhalation Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denufosol Tetrasodium (INS37217) Inhalation Solution | Drug | Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution, Denufosol 60 mg is administered as an inhalation solution, three times daily for twelve months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lung function | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Exacerbation, Antibiotic Use, Incidence of Hospitalization/ER visits, Health resource utilization, Quality of Life | 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felix Ratjen, MD, PhD | Toronto, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Pediatric Breathing Disorders |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22682898 | Derived | 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. |
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| Placebo | Drug | Placebo - 0.9% w/v sodium chloride solution, three times daily for twelve months. |
|
| Anchorage |
| Alaska |
| 99508 |
| United States |
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | United States |
| University of Arizona/Arizona Health Sciences | Tucson | Arizona | 85724 | United States |
| Childrens Hospital of Los Angeles | Los Angeles | California | 90027 | United States |
| USC Cystic Fibrosis Center | Los Angeles | California | 90033 | United States |
| Bay Area Pediatric Pulmonary | Oakland | California | 94609 | United States |
| Kaiser Permanente Medical Center | Oakland | California | 94611 | United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| Sanford University | Palo Alto | California | 94304 | United States |
| Capital Allergy & Respiratory Disease Center | Sacramento | California | 95819 | United States |
| UCSD Medical Center - Hillcrest & Thornton Hospitals | San Diego | California | 92103 | United States |
| UCSD Medical Center - Hillcrest and Thornton Hospitals | San Diego | California | 92103 | United States |
| Pediatric Diagnostic Center | Ventura | California | 93003 | United States |
| Yale School of Medicine | New Haven | Connecticut | 06520 | United States |
| Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Shands at University of Florida | Gainesville | Florida | 32610 | United States |
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
| Nemours Children's Clinic | Pensacola | Florida | 32504 | United States |
| Pediatric Pulmonary Associates | St. Petersburg | Florida | 33701 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| St. Mary's Medical Center | West Palm Beach | Florida | 33407 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Children's Healthcare of Atlanta at Scottish Rite | Atlanta | Georgia | 30342 | United States |
| Medical College of Georgia | Augusta | Georgia | 30912 | United States |
| Children's Memorial Hospital | Chicago | Illinois | 60614 | United States |
| Cystic Fibrosis Institute | Glenview | Illinois | 60025 | United States |
| James Whitcomb RIley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Via Christa Research | Wichita | Kansas | 67214 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Tulane University Medical Center | New Orleans | Louisiana | 70112 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| Spectrum Health Hospitals | Grand Rapids | Michigan | 49503 | United States |
| Children's Health Care | Minneapolis | Minnesota | 55404 | United States |
| University of Minnesota - Farview | Minneapolis | Minnesota | 55455 | United States |
| Childrens Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| Saint Louis University | St Louis | Missouri | 63104 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Children's Lung Specialists | Las Vegas | Nevada | 83107 | United States |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | United States |
| Monmouth Medical Center | Long Branch | New Jersey | 07740 | United States |
| The Respiratory Center for Children | Morristown | New Jersey | 07960 | United States |
| Albany Medical College | Albany | New York | 12208 | United States |
| Cystic Fibrosis Center of Schneider Children's Hospital | Great Neck | New York | 11021 | United States |
| New York Medical College | Hawthorne | New York | 10532 | United States |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | United States |
| St. Vincent's Catholic Medical Center | New York | New York | 10011 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| SUNY Upstate Medical University Hospital | Syracuse | New York | 13210 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| St. Alexius Medical Center | Bismarck | North Dakota | 58501 | United States |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| University Hospital of Cleveland | Cleveland | Ohio | 44106 | United States |
| Columbus Children's Hospital | Columbus | Ohio | 43205 | United States |
| The Children's Medical Center of Dayton | Dayton | Ohio | 45404 | United States |
| Toledo Children's Hospital | Toledo | Ohio | 43606 | United States |
| Santiago Reyes, MD | Oklahoma City | Oklahoma | 73112 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| PennState Milton S Hershey Med | Hershey | Pennsylvania | 17033 | United States |
| The Childrens Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Childrens Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Sanford Childrens' Specialty Clinic | Sioux Falls | South Dakota | 57117 | United States |
| East Tennesse Children's Hospital - Pediatric Pulmonary and Respiratory Care | Knoxville | Tennessee | 37916 | United States |
| Austin Children's Chest Associates | Austin | Texas | 78723 | United States |
| Dallas Cystic Fibrosis Center | Dallas | Texas | 75235 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Children's Hospital of the King's Daughters | Norfolk | Virginia | 23507 | United States |
| Naval Medical Center Portsmouth | Portsmouth | Virginia | 84132 | United States |
| Pediatric Pulmonary Clinic | Richmond | Virginia | 23219 | United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| University of Wisconsin School of Medicine and Pulbic Health | Madison | Wisconsin | 53792 | United States |
| John Hunter Hospital - Adults | New Lambton | New South Wales | 2305 | Australia |
| Westmead Adults | Westmead | New South Wales | 2145 | Australia |
| Prince Charles Hospital | Chermside | Queensland | 4032 | Australia |
| Royal Brisbane Children's Hospital | Herston | Queensland | 4029 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Respiratory Medicine | Parkville | Victoria | 3052 | Australia |
| Sire Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| Princess Margaret Hospital for Children | Perth | Western Australia | 6840 | Australia |
| The Children's Hospital of Westmead | Westmead | NSW 2145 | Australia |
| University of Calgary, Alberta Children's Hospital | Calgary | Alberta | T3B 6A8 | Canada |
| St. Paul's Hospital | Vancouver | British Columbia | V621Y6 | Canada |
| British Columbia Children's Hospital | Vancouver | British Columbia | V64 3V4 | Canada |
| Eastern Health | St. John's | Newfoundland and Labrador | AIA 3V6 | Canada |
| Eastern Health | St. John's | Newfoundland and Labrador | AIA346 | Canada |
| Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | B3H 3A7 | Canada |
| McMaster University | Hamilton | Ontario | L8N 325 | Canada |
| A. Lyttle Research COmpany | London | Ontario | N6A1V2 | Canada |
| Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| University of Toronto | Toronto | Ontario | M5B 1W8 | Canada |
| Hospital for Sick Children | Toronto | Ontario | MSG 1XB | Canada |
| Centre Mere-Enfant du CHUL | Montreal | Quebec | HZW 1T7 | Canada |
| Green Lane Clinical Centre (NZ) | Auckland | New Zealand |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| C465279 | denufosol tetrasodium |
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