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 3

Terminated

• Conditions: Cystic Fibrosis
• Interventions: Drug: Denufosol tetrasodium Inhalation Solution

• Registration Number: NCT00846781
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-18
• Study First Submitted QC: 2009-02-18
• Study First Posted: 2009-02-19
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Disposition First Submitted: 2011-05-20
• Disposition First Submitted QC: 2011-05-20
• Disposition First Posted: 2011-05-23
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-15
• Last Update Posted: 2015-11-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 308

Inclusion Criteria

• Completed Study 08-110

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Denufosol tetrasodium Inhalation Solution	Denufosol tetrasodium Inhalation Solution	-

Primary Outcome Measures

Name	Time	Method
Rate of change in lung function, as measured by change in FEV1	160 Weeks

Secondary Outcome Measures

Name	Time	Method
Change in absolute FEV1 from baseline	Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160
Change in FEV1 percent predicted value from baseline	Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160
Change in FEF25%-75% and forced vital capacity (FVC) from baseline	Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160
Incidence of pulmonary exacerbations	160 Weeks
Changes in Pseudomonas aeruginosa status	160 Weeks
Number of days of intravenous (IV) antibiotic use for a respiratory complaint	160 Weeks
Incidence of hospitalizations/Emergency room (ER) visits for a respiratory complaint	160 Weeks
Number of days hospitalized for a respiratory complaint	160 Weeks
Incidence of treatment emergent adverse events (AEs), serious adverse events (SAEs) and withdrawals due to AEs	160 Weeks
Incidence of patients with significant decrease in absolute FEV1 at any visit from baseline	160 Weeks
Changes in physical exam findings including height, weight, and body mass index from baseline	Weeks 48, 96, and 160
Changes in hematology, serum chemistry, and urinalysis parameters from baseline	Weeks 24, 48, 72, 96, 120, 144, and 160
Incidence of hospitalizations/ER visits	160 Weeks
Incidence of early discontinuations from the study	160 Weeks