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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Cystic Fibrosis

Treatments: Drug: denufosol tetrasodium (INS37217) Inhalation Solution; Drug: Placebo - 0.9% w/v sodium chloride solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00357279

08-108

Details and patient eligibility

About

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.

Enrollment: 352 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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352 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo - 0.9% w/v sodium chloride solution

2

Experimental group

Treatment:

Drug: denufosol tetrasodium (INS37217) Inhalation Solution