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)

Tracking Information
First Submitted Date ICMJE	February 18, 2009
First Posted Date ICMJE	February 19, 2009
Last Update Posted Date	November 6, 2015
Study Start Date ICMJE	February 2009
Actual Primary Completion Date	February 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 2, 2010)	Rate of change in lung function, as measured by change in FEV1 [ Time Frame: 160 Weeks ]
Original Primary Outcome Measures ICMJE; (submitted: February 18, 2009)	Change in Lung Function [ Time Frame: 48 weeks ]
Change History	Complete list of historical versions of study NCT00846781 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 2, 2010)	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 [ Time Frame: 160 Weeks ]; Changes in physical exam findings including height, weight, and body mass index from baseline [ Time Frame: Weeks 48, 96, and 160 ]; Changes in hematology, serum chemistry, and urinalysis parameters from baseline [ Time Frame: Weeks 24, 48, 72, 96, 120, 144, and 160 ]; Incidence of hospitalizations/ER visits [ Time Frame: 160 Weeks ]; Incidence of early discontinuations from the study [ Time Frame: 160 Weeks ]
Original Secondary Outcome Measures ICMJE; (submitted: February 18, 2009)	Pulmonary exacerbation, antibiotic use, incidence of hospitalizations/ER visits [ Time Frame: 48 weeks ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	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)
Official Title ICMJE	Not Provided
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 Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Cystic Fibrosis
Intervention ICMJE	Drug: Denufosol tetrasodium Inhalation Solution; 60 mg by oral inhalation three times daily
Study Arms	Experimental: Denufosol tetrasodium Inhalation Solution; Intervention: Drug: Denufosol tetrasodium Inhalation Solution
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: April 18, 2013)	308
Original Estimated Enrollment ICMJE; (submitted: February 18, 2009)	380
Actual Study Completion Date	February 2011
Actual Primary Completion Date	February 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	5 Years and older (Child, Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries	Australia, Canada, New Zealand, United States
Administrative Information
NCT Number ICMJE	NCT00846781
Other Study ID Numbers ICMJE	P08642; 08-114
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Merck Sharp & Dohme Corp.
Study Sponsor ICMJE	Merck Sharp & Dohme Corp.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Lynn Smiley, MD Medical Monitor
PRS Account	Merck Sharp & Dohme Corp.
Verification Date	October 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP