Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease - Full Text View

Sponsored by:	Inspire Pharmaceuticals
Information provided by:	Inspire Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00103714

Purpose

The objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of two dose levels of INS37217 (denufosol tetrasodium) Inhalation Solution in patients with cystic fibrosis (CF) lung disease.

Condition	Intervention	Phase
Cystic Fibrosis	Drug: denufosol tetrasodium (INS37217)	Phase II

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: INS37217 Denufosol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Cystic Fibrosis Lung Disease

Further study details as provided by Inspire Pharmaceuticals:

Primary Outcome Measures:

respiratory function

Secondary Outcome Measures:

adverse events
change in standard safety parameters
respiratory symptoms via questionnaire
pulmonary exacerbation

Estimated Enrollment:	72
Study Start Date:	January 2005
Estimated Study Completion Date:	September 2005

Eligibility

Ages Eligible for Study:	8 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have confirmed diagnosis of CF
Have an FEV1 greater than or equal to 60% or less than or equal to 90% of predicted normal
Have oxygen saturation greater than or equal to 90% on room air
Be clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation
Be able to reproducibly perform spirometry maneuvers

Exclusion Criteria:

Have changed their physiotherapy technique or schedule within 7 days prior to screening
Have clinically significant comorbidities
Using prior and concurrent medications according to the protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103714

Locations

United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94304
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
United States, Colorado
The Children's Hospital
Denver, Colorado, United States, 80218
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Joey O'Donnell Cystic Fibrosis Center, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Minnesota
The Minnesota CF Center, Univ. of Minnesota
Minneapolis, Minnesota, United States, 55455
General Clinical Research Center, Univ. of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Cardinal Glennon Children's Hospital
St. Louis, Missouri, United States, 63104
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
St. Vincent's Medical Center
New York, New York, United States, 10011
United States, North Carolina
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Columbus Children's Hospital
Columbus, Ohio, United States, 43205
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
United States, South Carolina
Pediatric Pulmonary Associates
Columbia, South Carolina, United States, 29203
United States, Tennessee
Vanderbilt Children's Hospital
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Baylor College of Medicine
Houston, Texas, United States, 77030
Methodist Hospital
Houston, Texas, United States, 77030

Sponsors and Collaborators

Inspire Pharmaceuticals

Investigators

Study Director:

Amy Schaberg, BSN

Unaffiliated

More Information

Study ID Numbers:	08-104
Study First Received:	February 14, 2005
Last Updated:	January 17, 2006
ClinicalTrials.gov Identifier:	NCT00103714
Health Authority:	United States: Food and Drug Administration

Keywords provided by Inspire Pharmaceuticals:

lung disease

Study placed in the following topic categories:

Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis
Fibrosis

Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Cystic fibrosis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009