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Study of Denufosol Inhalation Solution in Patients With Mild to Moderate Cystic Fibrosis Lung Disease

This study has been terminated.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00425165
First received: January 19, 2007
Last updated: March 31, 2011
Last verified: January 2009
History of Changes
  Purpose

The purpose of this trial is to evaluate the effects of a single dose of denufosol versus placebo on mucociliary clearance in patients with mild to moderate CF lung disease


Condition Intervention Phase
Cystic Fibrosis
 Drug: denufosol tetrasodium (INS37217) Inhalation Solution
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Two Way Crossover Evaluation of the Effects of a Single Dose of Denufosol Tetrasodium (INS37217) Inhalation Solution Versus Placebo (0.9% Sodium Chloride Solution) on Mucociliary Clearance in Patients With Mild to Moderate 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:
  • Change in mucociliary clearance from baseline [ Time Frame: 30, 60, and 90 minutes post aerosol inhalation ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: July 2007
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: denufosol tetrasodium (INS37217) Inhalation Solution
    Denufosol 60 mg is administered as an inhalation solution one time during the study.
  Eligibility

Ages Eligible for Study:   10 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 60% 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 with abnormalities suggesting clinically significant active pulmonary disease
  • have had a lung transplant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00425165

Locations
United States, North Carolina
UNC Hospitals
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
Merck
  More Information

No publications provided

Responsible Party: Amy Schaberg, RN, BSN, Vice President, Respiratory Clinical Research, Inspire Pharmacauticals
ClinicalTrials.gov Identifier: NCT00425165     History of Changes
Other Study ID Numbers: 08-111
Study First Received: January 19, 2007
Last Updated: March 31, 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 19, 2013