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

Merck Sharp & Dohme LLC352 enrolled

Overview

The purpose of this trial is to evaluate the safety and effectiveness of a one dose strength of denufosol compared to placebo in patients with mild CF lung disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

352

Conditions

Cystic Fibrosis

Interventions

denufosol tetrasodium (INS37217) Inhalation SolutionDRUG

Denufosol 60 mg is administered as an inhalation solution, three times daily for six months during the double-blind portion of the study. Subsequently, denufosol 60 mg is administered for an additional six months during the open label safety extension.

Placebo - 0.9% w/v sodium chloride solutionDRUG

4.2 mL of solution, allowing delivery of approximately 4 mL into the nebulizer cup for nebulization, three times daily for six months.

Eligibility

Sex: ALLMin age: 5 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in lung function

Time frame: 48 weeks

Secondary Outcomes

Pulmonary exacerbation

Time frame: 48 weeks

Requirements for concomitant CF medications

Time frame: 48 weeks

Quality of Life

Time frame: 48 weeks

Data from ClinicalTrials.gov

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