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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:  NCT00425165
Date of registration: 19/01/2007
Prospective Registration: Yes
Primary sponsor: Merck Sharp & Dohme Corp.
Public title: Study of Denufosol Inhalation Solution in Patients With Mild to Moderate Cystic Fibrosis Lung Disease
Scientific 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
Date of first enrolment: July 2007
Target sample size: 6
Recruitment status: Terminated
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United States
Key inclusion & exclusion criteria

Inclusion Criteria:

- have confirmed diagnosis of cystic fibrosis

- have FEV1 of greater than or equal to 60% 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 with abnormalities suggesting clinically significant
active pulmonary disease

- have had a lung transplant

Age minimum: 10 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Cystic Fibrosis
Drug: denufosol tetrasodium (INS37217) Inhalation Solution
Primary Outcome(s)
Change in mucociliary clearance from baseline [Time Frame: 30, 60, and 90 minutes post aerosol inhalation]
Secondary Outcome(s)
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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