Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00625612
First received: February 12, 2008
Last updated: April 24, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cystic Fibrosis |
Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
cystic fibrosis
MedlinePlus related topics:
Cystic Fibrosis
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- Change in lung function [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pulmonary Exacerbation, Antibiotic Use, Incidence of Hospitalization/ER visits, Health resource utilization, Quality of Life [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 466 |
| Study Start Date: | February 2008 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 2 |
Drug: Placebo
Placebo - 0.9% w/v sodium chloride solution, three times daily for twelve months.
|
|
Experimental: 1
Denufosol Tetrasodium (INS37217) Inhalation Solution
|
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.
|
Eligibility| Ages Eligible for Study: | 5 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00625612
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| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35233 | |
| United States, Alaska | |
| Pediatric Breathing Disorders | |
| Anchorage, Alaska, United States, 99508 | |
| United States, Arizona | |
| Phoenix Childrens Hospital | |
| Phoenix, Arizona, United States, 85016 | |
| University of Arizona/Arizona Health Sciences | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| Childrens Hospital of Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| USC Cystic Fibrosis Center | |
| Los Angeles, California, United States, 90033 | |
| Kaiser Permanente Medical Center | |
| Oakland, California, United States, 94611 | |
| Bay Area Pediatric Pulmonary | |
| Oakland, California, United States, 94609 | |
| Children's Hospital of Orange County | |
| Orange, California, United States, 92868 | |
| Sanford University | |
| Palo Alto, California, United States, 94304 | |
| Capital Allergy & Respiratory Disease Center | |
| Sacramento, California, United States, 95819 | |
| UCSD Medical Center - Hillcrest & Thornton Hospitals | |
| San Diego, California, United States, 92103 | |
| UCSD Medical Center - Hillcrest and Thornton Hospitals | |
| San Diego, California, United States, 92103 | |
| Pediatric Diagnostic Center | |
| Ventura, California, United States, 93003 | |
| United States, Connecticut | |
| Yale School of Medicine | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Delaware | |
| Alfred I. duPont Hospital for Children | |
| Wilmington, Delaware, United States, 19803 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Shands at University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| Nemours Children's Clinic | |
| Jacksonville, Florida, United States, 32207 | |
| Nemours Children's Clinic | |
| Pensacola, Florida, United States, 32504 | |
| Pediatric Pulmonary Associates | |
| St. Petersburg, Florida, United States, 33701 | |
| Tampa General Hospital | |
| Tampa, Florida, United States, 33606 | |
| St. Mary's Medical Center | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| Children's Healthcare of Atlanta at Scottish Rite | |
| Atlanta, Georgia, United States, 30342 | |
| Medical College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| United States, Illinois | |
| Children's Memorial Hospital | |
| Chicago, Illinois, United States, 60614 | |
| Cystic Fibrosis Institute | |
| Glenview, Illinois, United States, 60025 | |
| United States, Indiana | |
| James Whitcomb RIley Hospital for Children | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| Via Christa Research | |
| Wichita, Kansas, United States, 67214 | |
| United States, Kentucky | |
| University of Kentucky | |
| Lexington, Kentucky, United States, 40536 | |
| United States, Louisiana | |
| Tulane University Medical Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maine | |
| Maine Medical Center | |
| Portland, Maine, United States, 04102 | |
| United States, Maryland | |
| Johns Hopkins University School of Medicine | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Boston Children's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| University of Michigan Health System | |
| Ann Arbor, Michigan, United States, 48109 | |
| Spectrum Health Hospitals | |
| Grand Rapids, Michigan, United States, 49503 | |
| United States, Minnesota | |
| University of Minnesota - Farview | |
| Minneapolis, Minnesota, United States, 55455 | |
| Children's Health Care | |
| Minneapolis, Minnesota, United States, 55404 | |
| United States, Missouri | |
| Childrens Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| Saint Louis University | |
| St. Louis, Missouri, United States, 63104 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198 | |
| United States, Nevada | |
| Children's Lung Specialists | |
| Las Vegas, Nevada, United States, 83107 | |
| United States, New Jersey | |
| Saint Barnabas Medical Center | |
| Livingston, New Jersey, United States, 07039 | |
| Monmouth Medical Center | |
| Long Branch, New Jersey, United States, 07740 | |
| The Respiratory Center for Children | |
| Morristown, New Jersey, United States, 07960 | |
| United States, New York | |
| Albany Medical College | |
| Albany, New York, United States, 12208 | |
| Cystic Fibrosis Center of Schneider Children's Hospital | |
| Great Neck, New York, United States, 11021 | |
| New York Medical College | |
| Hawthorne, New York, United States, 10532 | |
| Long Island Jewish Medical Center | |
| New Hyde Park, New York, United States, 11040 | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| St. Vincent's Catholic Medical Center | |
| New York, New York, United States, 10011 | |
| University of Rochester | |
| Rochester, New York, United States, 14642 | |
| SUNY Upstate Medical University Hospital | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, North Dakota | |
| St. Alexius Medical Center | |
| Bismark, North Dakota, United States, 58501 | |
| United States, Ohio | |
| Children's Hospital Medical Center of Akron | |
| Akron, Ohio, United States, 44308 | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229 | |
| University Hospital of Cleveland | |
| Cleveland, Ohio, United States, 44106 | |
| Columbus Children's Hospital | |
| Columbus, Ohio, United States, 43205 | |
| The Children's Medical Center of Dayton | |
| Dayton, Ohio, United States, 45404 | |
| Toledo Children's Hospital | |
| Toledo, Ohio, United States, 43606 | |
| United States, Oklahoma | |
| Santiago Reyes, MD | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Oregon | |
| Oregon Health and Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| PennState Milton S Hershey Med | |
| Hershey, Pennsylvania, United States, 17033 | |
| The Childrens Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Childrens Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, South Dakota | |
| Sanford Childrens' Specialty Clinic | |
| Sioux Falls, South Dakota, United States, 57117 | |
| United States, Tennessee | |
| East Tennesse Children's Hospital - Pediatric Pulmonary and Respiratory Care | |
| Knoxville, Tennessee, United States, 37916 | |
| United States, Texas | |
| Austin Children's Chest Associates | |
| Austin, Texas, United States, 78723 | |
| Dallas Cystic Fibrosis Center | |
| Dallas, Texas, United States, 75235 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| University of Utah | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Virginia | |
| University of Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| Children's Hospital of the King's Daughters | |
| Norfolk, Virginia, United States, 23507 | |
| Naval Medical Center Portsmouth | |
| Portsmouth, Virginia, United States, 84132 | |
| Pediatric Pulmonary Clinic | |
| Richmond, Virginia, United States, 23219 | |
| United States, West Virginia | |
| West Virginia University | |
| Morgantown, West Virginia, United States, 26506 | |
| United States, Wisconsin | |
| University of Wisconsin School of Medicine and Pulbic Health | |
| Madison, Wisconsin, United States, 53792 | |
| University of Wisconsin Hospital and Clinics | |
| Madison, Wisconsin, United States, 53792 | |
| Australia, New South Wales | |
| John Hunter Hospital - Adults | |
| New Lambton, New South Wales, Australia, 2305 | |
| Westmead Adults | |
| Westmead, New South Wales, Australia, 2145 | |
| Australia, Queensland | |
| Prince Charles Hospital | |
| Chermside, Queensland, Australia, 4032 | |
| Royal Brisbane Children's Hospital | |
| Herston, Queensland, Australia, 4029 | |
| Australia, South Australia | |
| Royal Adelaide Hospital | |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Victoria | |
| Monash Medical Centre | |
| Clayton, Victoria, Australia, 3168 | |
| Alfred Hospital | |
| Melbourne, Victoria, Australia, 3004 | |
| Respiratory Medicine | |
| Parkville, Victoria, Australia, 3052 | |
| Australia, Western Australia | |
| Sire Charles Gairdner Hospital | |
| Nedlands, Western Australia, Australia, 6009 | |
| Princess Margaret Hospital for Children | |
| Perth, Western Australia, Australia, 6840 | |
| Australia | |
| The Children's Hospital of Westmead | |
| Westmead, Australia, NSW 2145 | |
| Canada, Alberta | |
| University of Calgary, Alberta Children's Hospital | |
| Calgary, Alberta, Canada, T3B 6A8 | |
| Canada, British Columbia | |
| British Columbia Children's Hospital | |
| Vancouver, British Columbia, Canada, V64 3V4 | |
| St. Paul's Hospital | |
| Vancouver, British Columbia, Canada, V621Y6 | |
| Canada, Newfoundland and Labrador | |
| Eastern Health | |
| St. John's, Newfoundland and Labrador, Canada, AIA346 | |
| Eastern Health | |
| St. Johns, Newfoundland and Labrador, Canada, AIA 3V6 | |
| Canada, Nova Scotia | |
| Queen Elizabeth II Health Sciences Centre | |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Canada, Ontario | |
| McMaster University | |
| Hamilton, Ontario, Canada, L8N 325 | |
| A. Lyttle Research COmpany | |
| London, Ontario, Canada, N6A1V2 | |
| Ottawa Hospital | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| University of Toronto | |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Hospital for Sick Children | |
| Toronto, Ontario, Canada, MSG 1XB | |
| Canada, Quebec | |
| Centre Mere-Enfant du CHUL | |
| Montreal, Quebec, Canada, HZW 1T7 | |
| New Zealand | |
| Green Lane Clinical Centre (NZ) | |
| Auckland, New Zealand | |
Sponsors and Collaborators
Merck
Investigators
| Principal Investigator: | Felix Ratjen, MD, PhD | Toronto, Canada |
More Information
No publications provided by Merck
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Inspire Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00625612 History of Changes |
| Other Study ID Numbers: | 08-110, P08640 |
| Study First Received: | February 12, 2008 |
| Last Updated: | April 24, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Cystic Fibrosis Fibrosis Lung Diseases Pancreatic Diseases Digestive System Diseases |
Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013