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

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. Identifier: NCT00425165
Recruitment Status : Terminated
First Posted : January 22, 2007
Last Update Posted : April 3, 2015
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

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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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