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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:
ClinicalTrials.gov Identifier:
NCT00425165
First Posted: January 22, 2007
Last Update Posted: April 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change in mucociliary clearance from baseline [ Time Frame: 30, 60, and 90 minutes post aerosol inhalation ]

Enrollment: 6
Study Start Date: August 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00425165     History of Changes
Other Study ID Numbers: 08-111
First Submitted: January 19, 2007
First Posted: January 22, 2007
Last Update Posted: April 3, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Lung Diseases
Pulmonary Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pharmaceutical Solutions