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

Cystic Fibrosis Clinical Trial

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00425165
• Other study ID #: 08-111
• Status: Terminated
• Phase: Phase 2
• First received: January 19, 2007
• Last updated: March 17, 2015
• Start date: August 2007
• Est. completion date: May 2008

Study information

• Verified date: March 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to evaluate the effects of a single dose of denufosol versus placebo on mucociliary clearance in patients with mild to moderate CF lung disease

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• have confirmed diagnosis of cystic fibrosis

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

• have had a lung transplant

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Lung Diseases
• Pulmonary Fibrosis

Intervention

Drug:
• denufosol tetrasodium (INS37217) Inhalation Solution
Denufosol 60 mg is administered as an inhalation solution one time during the study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mucociliary clearance from baseline		30, 60, and 90 minutes post aerosol inhalation	No