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Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00103714
First received: February 14, 2005
Last updated: January 17, 2006
Last verified: January 2006
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by Merck:

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
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Stanford University Medical Center
Palo Alto, California, United States, 94304
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
St. Vincent's Medical Center
New York, New York, United States, 10011
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
Columbus Children's Hospital
Columbus, Ohio, United States, 43205
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
Merck
Investigators
Study Director: Amy Schaberg, BSN
  More Information

No publications provided

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

Keywords provided by Merck:
lung disease

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 22, 2013