Study of Denufosol Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00357279
First received: July 25, 2006
Last updated: March 30, 2011
Last verified: June 2008
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this trial is to evaluate the safety and effectiveness of a one dose strength of denufosol compared to placebo in patients with mild CF lung disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Cystic Fibrosis |
Drug: denufosol tetrasodium (INS37217) Inhalation Solution Drug: Placebo - 0.9% w/v sodium chloride solution |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multi-Center, Double-Blind, Placebo-Controlled Randomized, Efficacy and Safety Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease |
Resource links provided by NLM:
Genetics Home Reference related topics:
cystic fibrosis
MedlinePlus related topics:
Cystic Fibrosis
Drug Information available for:
Sodium chloride
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: Yes ]
Secondary Outcome Measures:
- Pulmonary exacerbation [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
- Requirements for concomitant CF medications [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 350 |
| Study Start Date: | July 2006 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Placebo
|
Drug: Placebo - 0.9% w/v sodium chloride solution
4.2 mL of solution, allowing delivery of approximately 4 mL into the nebulizer cup for nebulization, three times daily for six months.
|
| Experimental: 2 |
Drug: denufosol tetrasodium (INS37217) Inhalation Solution
Denufosol 60 mg is administered as an inhalation solution, three times daily for six months during the double-blind portion of the study. Subsequently, denufosol 60 mg is administered for an additional six months during the open label safety extension.
|
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% of predicted normal for age, gender, and height
- Be able to reproducibly perform spirometry maneuvers
- Be clinically stable for at least 4 weeks prior to screening
Exclusion Criteria:
- Have abnormal renal or liver function
- Have chest x-ray at screening suggesting clinically significant active pulmonary disease
- Be colonized with Burkholderia cepacia
- Have had a lung transplant
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00357279
Hide Study Locations
Hide Study LocationsLocations
| United States, Alabama | |
| Children's Hospital | |
| Birmingham, Alabama, United States, 35233 | |
| University of Alabama at Birmingham Hospital and Clinics | |
| Birmingham, Alabama, United States, 35249 | |
| United States, Alaska | |
| Pediatric Breathing Disorders Clinic | |
| Anchorage, Alaska, United States, 99508 | |
| Providence Alaska Medical Center | |
| Anchorage, Alaska, United States, 99508 | |
| United States, Arizona | |
| Phoenix Children's Hospital | |
| Phoenix, Arizona, United States, 85016 | |
| United States, Arkansas | |
| Arkansas Children's Hospital | |
| Little Rock, Arkansas, United States, 72202 | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Childrens Hospital Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| Children'a Hospital and Research Center at Oakland | |
| Oakland, California, United States, 94609 | |
| Children's Hospital of Orange County | |
| Orange, California, United States, 92868 | |
| Children's Hospital of Orange County Pulmonary Clinic | |
| Orange, California, United States, 92868 | |
| Capital Allergy and Respiratory Disease Center | |
| Roseville, California, United States, 95661 | |
| Capital Allergy and Respiratory Disease Center | |
| Sacramento, California, United States, 95819 | |
| UC Davis Medical Center | |
| Sacramento, California, United States, 95817 | |
| Stanford University Hospital and Clinics | |
| Stanford, California, United States, 94305-5236 | |
| United States, Colorado | |
| The Children's Hospital | |
| Denver, Colorado, United States, 80218 | |
| United States, Connecticut | |
| Connecticut Children's Medical Center | |
| Hartford, Connecticut, United States, 06106 | |
| Yale School of Medicine | |
| New Haven, Connecticut, United States, 06520-8064 | |
| United States, Delaware | |
| Alfred I. duPont Hospital for Children | |
| Wilmington, Delaware, United States, 19803 | |
| United States, Florida | |
| Shands at the University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| Nemours Children's Clinic | |
| Jacksonville, Florida, United States, 32207 | |
| Miami Children's Hospital | |
| Miami, Florida, United States, 33155 | |
| Nemours Children's Clinic | |
| Orlando, Florida, United States, 32806 | |
| United States, Georgia | |
| Emory Cystic Fibrosis Center | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Children's Memorial Hospital | |
| Chicago, Illinois, United States, 60614 | |
| Chicago CF Care Specialists/CFI | |
| Glenview, Illinois, United States, 60025 | |
| Loyola University Medical Center Outpatient Center | |
| Maywood, Illinois, United States, 60153 | |
| Oakbrook Terrace Medical Center | |
| Oakbrook Terrace, Illinois, United States, 60181 | |
| United States, Indiana | |
| James Whitcomb Riley Hospital for Children | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242-1083 | |
| United States, Kansas | |
| Via Christi Specialty Clinics/CR Clinic | |
| Wichita, Kansas, United States, 67214 | |
| United States, Kentucky | |
| University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0284 | |
| United States, Louisiana | |
| Louisiana State University Health Sciences Center | |
| Shreveport, Louisiana, United States, 71130 | |
| United States, Maine | |
| Maine Medical Center | |
| Portland, Maine, United States, 04102 | |
| United States, Maryland | |
| Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Spectrum Health Cystic Fibrosis Care Center | |
| Grand Rapids, Michigan, United States, 49503 | |
| Michigan Medical PC | |
| Grand Rapids, Michigan, United States, 49546 | |
| Pediatric Pulmonary Clinic | |
| Grand Rapids, Michigan, United States, 49503 | |
| United States, Minnesota | |
| The Minnesota CF Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| Univeristy of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Cardinal Glennon Children's Medical Center | |
| St. Louis, Missouri, United States, 63104 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198 | |
| United States, Nevada | |
| Childrens Lung Specialists, LTD | |
| Las Vegas, Nevada, United States, 89107 | |
| United States, New Jersey | |
| Saint Barnabas Ambulatory Care Center | |
| Livingston, New Jersey, United States, 07039 | |
| The Respiratory Center for Children, Morristown Memorial Hospital | |
| Morristown, New Jersey, United States, 07962 | |
| United States, New York | |
| Women & Children's Hospital of Buffalo | |
| Buffalo, New York, United States, 14222 | |
| Irving Goldman Family Care Center | |
| Great Neck, New York, United States, 11021 | |
| Westchester Medical Center and New York Medical College | |
| Hawthorne, New York, United States, 10532 | |
| The Cystic Fibrosis Center St. Vincent's Hospital, Manhattan | |
| New York, New York, United States, 10011 | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| University of Rochester | |
| Rochester, New York, United States, 14642 | |
| SUNY Upstate Medical University Hospital | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| University of North Carolina at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229 | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44106 | |
| Children's Hospital | |
| Columbus, Ohio, United States, 43205 | |
| United States, Oklahoma | |
| Santiago Reyes | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Oregon | |
| Oregon Health and Sciences University, Hospital (OHSU) | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| PHH Cystic Fibrosis Center | |
| Harrisburg, Pennsylvania, United States, 17110 | |
| Penn State Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| The Childrens Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Children's Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, South Carolina | |
| Pediatric Pulmonary Associates | |
| Columbia, South Carolina, United States, 29203 | |
| United States, Texas | |
| Children's Medical Center Dallas, Dallas Cystic Fibrosis Center | |
| Dallas, Texas, United States, 75235 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Texas Children's Hospital | |
| Houston, Texas, United States, 77030 | |
| Alamo Clinical Research Associates | |
| San Antonio, Texas, United States, 78212 | |
| The University of Texas Health Science Center at San Antonia | |
| San Antonio, Texas, United States, 78229-3900 | |
| United States, Utah | |
| University of Utah | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Virginia | |
| University of Virginia Health System | |
| Charlottesville, Virginia, United States, 22908 | |
| Primary Care Center | |
| Charlottesville, Virginia, United States, 22908 | |
| Kluge Children's Rehabilitation Center | |
| Charlottesville, Virginia, United States, 22903 | |
| Naval Medical Center Portsmouth | |
| Portsmouth, Virginia, United States, 23708 | |
| Virginia Commonwealth University Pediatric Pulmonary Clinic | |
| Richmond, Virginia, United States, 23219 | |
| Virginia Commonwealth University Children's Pavilion | |
| Richmond, Virginia, United States, 23219 | |
| United States, Washington | |
| Childrens Hospital and Regional Medical Center | |
| Seattle, Washington, United States, 98105 | |
| University of Washington Medical Center | |
| Seattle, Washington, United States, 98195 | |
| United States, Wisconsin | |
| University of Wisconsin Hospital and Clinics | |
| Madison, Wisconsin, United States, 53792 | |
| Canada, British Columbia | |
| British Columbia's Children's Hospital | |
| Vancouver, British Columbia, Canada, V6H-3V4 | |
| Canada, Nova Scotia | |
| Queen Elizabeth II Health Sciences Center | |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
Sponsors and Collaborators
Merck
More Information
No publications provided by Merck
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amy Schaberg, RN, BSN Vice President Respiratory Clinical Research, Inspire Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00357279 History of Changes |
| Other Study ID Numbers: | 08-108 |
| Study First Received: | July 25, 2006 |
| Last Updated: | March 30, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Cystic Fibrosis Fibrosis Lung Diseases Pulmonary Fibrosis 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