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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Cystic Fibrosis	Drug: Denufosol tetrasodium Inhalation Solution	Phase 3

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Rate of change in lung function, as measured by change in FEV1 [ Time Frame: 160 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Estimated Enrollment:	380
Study Start Date:	February 2009
Study Completion Date:	February 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Denufosol tetrasodium Inhalation Solution	Drug: Denufosol tetrasodium Inhalation Solution 60 mg by oral inhalation three times daily

Eligibility

Ages Eligible for Study:	5 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846781

Show 90 Study Locations

Sponsors and Collaborators

Merck

Investigators

Study Director:

Lynn Smiley, MD

Medical Monitor

More Information

No publications provided

Responsible Party:	Sarah Prodan, Associate Director, Inspire Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00846781 History of Changes
Other Study ID Numbers:	08-114, P08642
Study First Received:	February 18, 2009
Last Updated:	September 20, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases

Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 26, 2012

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 (DEFY)