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

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ClinicalTrials.gov Identifier: NCT00425165
Recruitment Status : Terminated
First Posted : January 22, 2007
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Cystic Fibrosis Drug: denufosol tetrasodium (INS37217) Inhalation Solution Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
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
Study Start Date : August 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: denufosol tetrasodium (INS37217) Inhalation Solution
    Denufosol 60 mg is administered as an inhalation solution one time during the study.


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


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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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00425165     History of Changes
Other Study ID Numbers: 08-111
First Posted: January 22, 2007    Key Record Dates
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