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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)

Primary Purpose

Cystic Fibrosis

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Denufosol tetrasodium Inhalation Solution
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Denufosol tetrasodium Inhalation Solution

    Arm Description

    Outcomes

    Primary Outcome Measures

    Rate of change in lung function, as measured by change in FEV1

    Secondary Outcome Measures

    Change in absolute FEV1 from baseline
    Change in FEV1 percent predicted value from baseline
    Change in FEF25%-75% and forced vital capacity (FVC) from baseline
    Incidence of pulmonary exacerbations
    Changes in Pseudomonas aeruginosa status
    Number of days of intravenous (IV) antibiotic use for a respiratory complaint
    Incidence of hospitalizations/Emergency room (ER) visits for a respiratory complaint
    Number of days hospitalized for a respiratory complaint
    Incidence of treatment emergent adverse events (AEs), serious adverse events (SAEs) and withdrawals due to AEs
    Incidence of patients with significant decrease in absolute FEV1 at any visit from baseline
    Changes in physical exam findings including height, weight, and body mass index from baseline
    Changes in hematology, serum chemistry, and urinalysis parameters from baseline
    Incidence of hospitalizations/ER visits
    Incidence of early discontinuations from the study

    Full Information

    First Posted
    February 18, 2009
    Last Updated
    October 15, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00846781
    Brief Title
    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)
    Acronym
    DEFY
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Terminated
    Study Start Date
    February 2009 (undefined)
    Primary Completion Date
    February 2011 (Actual)
    Study Completion Date
    February 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cystic Fibrosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    308 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Denufosol tetrasodium Inhalation Solution
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Denufosol tetrasodium Inhalation Solution
    Intervention Description
    60 mg by oral inhalation three times daily
    Primary Outcome Measure Information:
    Title
    Rate of change in lung function, as measured by change in FEV1
    Time Frame
    160 Weeks
    Secondary Outcome Measure Information:
    Title
    Change in absolute FEV1 from baseline
    Time Frame
    Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160
    Title
    Change in FEV1 percent predicted value from baseline
    Time Frame
    Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160
    Title
    Change in FEF25%-75% and forced vital capacity (FVC) from baseline
    Time Frame
    Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160
    Title
    Incidence of pulmonary exacerbations
    Time Frame
    160 Weeks
    Title
    Changes in Pseudomonas aeruginosa status
    Time Frame
    160 Weeks
    Title
    Number of days of intravenous (IV) antibiotic use for a respiratory complaint
    Time Frame
    160 Weeks
    Title
    Incidence of hospitalizations/Emergency room (ER) visits for a respiratory complaint
    Time Frame
    160 Weeks
    Title
    Number of days hospitalized for a respiratory complaint
    Time Frame
    160 Weeks
    Title
    Incidence of treatment emergent adverse events (AEs), serious adverse events (SAEs) and withdrawals due to AEs
    Time Frame
    160 Weeks
    Title
    Incidence of patients with significant decrease in absolute FEV1 at any visit from baseline
    Time Frame
    160 Weeks
    Title
    Changes in physical exam findings including height, weight, and body mass index from baseline
    Time Frame
    Weeks 48, 96, and 160
    Title
    Changes in hematology, serum chemistry, and urinalysis parameters from baseline
    Time Frame
    Weeks 24, 48, 72, 96, 120, 144, and 160
    Title
    Incidence of hospitalizations/ER visits
    Time Frame
    160 Weeks
    Title
    Incidence of early discontinuations from the study
    Time Frame
    160 Weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lynn Smiley, MD
    Organizational Affiliation
    Medical Monitor
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    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)

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