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)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00846781
First received: February 18, 2009
Last updated: October 29, 2013
Last verified: October 2013
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]

Enrollment: 308
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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Lynn Smiley, MD Medical Monitor
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00846781     History of Changes
Other Study ID Numbers: P08642, 08-114
Study First Received: February 18, 2009
Last Updated: October 29, 2013
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 April 16, 2014