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)

Phase 3TerminatedNCT00846781

Merck Sharp & Dohme LLC308 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

308

Conditions

Cystic Fibrosis

Interventions

Denufosol tetrasodium Inhalation SolutionDRUG

60 mg by oral inhalation three times daily

Eligibility

Sex: ALLMin age: 5 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Rate of change in lung function, as measured by change in FEV1

Time frame: 160 Weeks

Secondary Outcomes

Change in absolute FEV1 from baseline

Time frame: Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160

Change in FEV1 percent predicted value from baseline

Time frame: Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160

Change in FEF25%-75% and forced vital capacity (FVC) from baseline

Time frame: Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160

Incidence of pulmonary exacerbations

Time frame: 160 Weeks

Changes in Pseudomonas aeruginosa status

Time frame: 160 Weeks

Number of days of intravenous (IV) antibiotic use for a respiratory complaint

Time frame: 160 Weeks

Incidence of hospitalizations/Emergency room (ER) visits for a respiratory complaint

Time frame: 160 Weeks

Number of days hospitalized for a respiratory complaint

Time frame: 160 Weeks

Incidence of treatment emergent adverse events (AEs), serious adverse events (SAEs) and withdrawals due to AEs

Time frame: 160 Weeks

Incidence of patients with significant decrease in absolute FEV1 at any visit from baseline

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.