World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00357279
Date of registration: 25/07/2006
Prospective Registration: Yes
Primary sponsor: Merck Sharp & Dohme Corp.
Public title: Study of Denufosol Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease
Scientific 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
Date of first enrolment: July 2006
Target sample size: 352
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00357279
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Canada United States
Contacts
Key inclusion & exclusion criteria

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



Age minimum: 5 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Cystic Fibrosis
Intervention(s)
Drug: denufosol tetrasodium (INS37217) Inhalation Solution
Drug: Placebo - 0.9% w/v sodium chloride solution
Primary Outcome(s)
Change in lung function [Time Frame: 48 weeks]
Secondary Outcome(s)
Pulmonary exacerbation [Time Frame: 48 weeks]
Quality of Life [Time Frame: 48 weeks]
Requirements for concomitant CF medications [Time Frame: 48 weeks]
Secondary ID(s)
08-108
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history