Back to results

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

Primary Purpose

Cystic Fibrosis

Status

Terminated

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

denufosol tetrasodium (INS37217) Inhalation Solution

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Change in mucociliary clearance from baseline

Secondary Outcome Measures

Full Information

NCT ID

NCT00425165

First Posted

January 19, 2007

Last Updated

March 17, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00425165

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Terminated

Study Start Date

August 2007 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

denufosol tetrasodium (INS37217) Inhalation Solution

Intervention Description

Denufosol 60 mg is administered as an inhalation solution one time during the study.

Primary Outcome Measure Information:

Title

Change in mucociliary clearance from baseline

Time Frame

30, 60, and 90 minutes post aerosol inhalation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility 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 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

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs