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)

Cystic Fibrosis Clinical Trial

— DEFY  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00846781
• Other study ID #: P08642
• Secondary ID: 08-114
• Status: Terminated
• Phase: Phase 3
• First received: February 18, 2009
• Last updated: October 15, 2015
• Start date: February 2009
• Est. completion date: February 2011

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 308
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Denufosol tetrasodium Inhalation Solution
60 mg by oral inhalation three times daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of change in lung function, as measured by change in FEV1		160 Weeks	No
Secondary	Change in absolute FEV1 from baseline		Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160	No
Secondary	Change in FEV1 percent predicted value from baseline		Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160	No
Secondary	Change in FEF25%-75% and forced vital capacity (FVC) from baseline		Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160	No
Secondary	Incidence of pulmonary exacerbations		160 Weeks	Yes
Secondary	Changes in Pseudomonas aeruginosa status		160 Weeks	Yes
Secondary	Number of days of intravenous (IV) antibiotic use for a respiratory complaint		160 Weeks	Yes
Secondary	Incidence of hospitalizations/Emergency room (ER) visits for a respiratory complaint		160 Weeks	Yes
Secondary	Number of days hospitalized for a respiratory complaint		160 Weeks	Yes
Secondary	Incidence of treatment emergent adverse events (AEs), serious adverse events (SAEs) and withdrawals due to AEs		160 Weeks	Yes
Secondary	Incidence of patients with significant decrease in absolute FEV1 at any visit from baseline		160 Weeks	Yes
Secondary	Changes in physical exam findings including height, weight, and body mass index from baseline		Weeks 48, 96, and 160	Yes
Secondary	Changes in hematology, serum chemistry, and urinalysis parameters from baseline		Weeks 24, 48, 72, 96, 120, 144, and 160	Yes
Secondary	Incidence of hospitalizations/ER visits		160 Weeks	Yes
Secondary	Incidence of early discontinuations from the study		160 Weeks	Yes