Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease - Full Text View

Sponsor:	Merck
Collaborator:	Cystic Fibrosis Foundation
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00056147

Purpose

The purpose of this study is to assess the safety and effectiveness of multiple dosages of INS37217 compared to placebo over 28 days in subjects with mild to moderate cystic fibrosis (CF) lung disease. Study drug will be administered through a nebulizer (a device that delivers medication as a mist by breathing it in).

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of INS37217 Inhalation Solution in Subjects With Mild to Moderate 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: Denufosol INS37217

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

lung function
respiratory symptoms
sputum weight
pulmonary exacerbations
measures of lung characteristics

Secondary Outcome Measures:

safety measures

Estimated Enrollment:	92
Study Start Date:	March 2003
Estimated Study Completion Date:	June 2004

Detailed Description:

The purpose of this study is to:

assess the safety and efficacy of multiple dose levels of INS37217 compared to placebo over 28 days in subjects with mild to moderate CF lung disease;
explore evidence of activity of INS37217 and placebo administered via PARI LC STAR nebulizer;
identify dose(s) that will be studied in subsequent trials.

Eligibility

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

Criteria

Inclusion Criteria:

confirmed diagnosis of CF
FEV1 greater than or equal to 75% of predicted normal for age, gender, and height
oxyhemoglobin saturation greater than or equal to 90%
clinically stable

Exclusion Criteria:

abnormal renal or liver function
clinically significant findings atypical for moderate cystic fibrosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056147

Locations

United States, California
Stanford University Hospital and Clinics
Palo Alto, California, United States, 94305
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
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Children's Hospital
Boston, Massachusetts, United States, 02115
United States, Minnesota
University of Minnesota General Clinical Research Center
Minneapolis, Minnesota, United States, 55455
Fairview University Medical Center
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Cardinal Glennon Children's Hospital
St. Louis, Missouri, United States, 63104
United States, North Carolina
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Cincinnati's Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Columbus Children's Hospital
Columbus, Ohio, United States, 43205
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
United States, Washington
Children's Hospital and Regional Medical Center
Seattle, Washington, United States, 98105
University of Washington Medical Center
Seattle, Washington, United States, 98195

Sponsors and Collaborators

Merck

Cystic Fibrosis Foundation

Investigators

Study Director:

Amy Schaberg, BSN

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00056147 History of Changes
Other Study ID Numbers:	08-103
Study First Received:	March 6, 2003
Last Updated:	September 13, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

cystic fibrosis

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 February 12, 2012