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Study of Denufosol Inhalation Solution in Patients With Mild 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: NCT00357279
Recruitment Status : Completed
First Posted : July 27, 2006
Last Update Posted : November 4, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 352 participants
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
Study Start Date : July 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   5 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 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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00357279    
Other Study ID Numbers: 08-108
First Posted: July 27, 2006    Key Record Dates
Last Update Posted: November 4, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Cystic Fibrosis
Lung Diseases
Pulmonary Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pharmaceutical Solutions