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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)

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ClinicalTrials.gov Identifier: NCT00846781
Recruitment Status : Terminated
First Posted : February 19, 2009
Last Update Posted : November 6, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Denufosol tetrasodium Inhalation Solution Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 308 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2009
Primary Completion Date : February 2011
Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Denufosol tetrasodium Inhalation Solution Drug: Denufosol tetrasodium Inhalation Solution
60 mg by oral inhalation three times daily

Primary Outcome Measures :
  1. Rate of change in lung function, as measured by change in FEV1 [ Time Frame: 160 Weeks ]

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

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00846781

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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00846781     History of Changes
Other Study ID Numbers: P08642
First Posted: February 19, 2009    Key Record Dates
Last Update Posted: November 6, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pharmaceutical Solutions