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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: July 27, 2006
Last Update Posted: November 4, 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.
The purpose of this trial is to evaluate the safety and effectiveness of a one dose strength of denufosol compared to placebo in patients with mild CF lung disease.

Condition Intervention Phase
Cystic Fibrosis Drug: denufosol tetrasodium (INS37217) Inhalation Solution Drug: Placebo - 0.9% w/v sodium chloride solution Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Double-Blind, Placebo-Controlled Randomized, Efficacy and Safety Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Change in lung function [ Time Frame: 48 weeks ]

Secondary Outcome Measures:
  • Pulmonary exacerbation [ Time Frame: 48 weeks ]
  • Requirements for concomitant CF medications [ Time Frame: 48 weeks ]
  • Quality of Life [ Time Frame: 48 weeks ]

Enrollment: 352
Study Start Date: July 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Drug: Placebo - 0.9% w/v sodium chloride solution
4.2 mL of solution, allowing delivery of approximately 4 mL into the nebulizer cup for nebulization, three times daily for six months.
Experimental: 2 Drug: denufosol tetrasodium (INS37217) Inhalation Solution
Denufosol 60 mg is administered as an inhalation solution, three times daily for six months during the double-blind portion of the study. Subsequently, denufosol 60 mg is administered for an additional six months during the open label safety extension.


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
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 75% 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 suggesting clinically significant active pulmonary disease
  • Be colonized with Burkholderia cepacia
  • Have had a lung transplant
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00357279     History of Changes
Other Study ID Numbers: 08-108
First Submitted: July 25, 2006
First Posted: July 27, 2006
Last Update Posted: November 4, 2015
Last Verified: October 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