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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.
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
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
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

- 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

- 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
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)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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