Study 08-114 Open-label Extension of Study 08-110 - A Multi-Center Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease (P08642) (DEFY)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 3

Conditions: Cystic Fibrosis

Treatments: Drug: Denufosol tetrasodium Inhalation Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00846781

08-114

P08642

Details and patient eligibility

About

The purpose of this study is to obtain data on the potential of long-term treatment with denufosol to improve the clinical course of CF lung disease in patients with mildly impaired lung function and to provide CF patients who completed study 08-110 continued access to denufosol.

Enrollment: 308 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completed Study 08-110

Exclusion criteria

• A female patient will not be eligible for the study if she is of childbearing potential and is pregnant, lactating, and/or not practicing an acceptable method of birth control (e.g., abstinence, hormonal or barrier methods, partner sterilization, or intrauterine device).
• Have a condition that might affect compliance with study procedures

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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308 participants in 1 patient group

Denufosol tetrasodium Inhalation Solution

Experimental group

Treatment:

Drug: Denufosol tetrasodium Inhalation Solution