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A Safety and Tolerability Study of Denufosol in 2-4 Year Olds (REACH-1)

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
denufosol tetrasodium Inhalation Solution
0.9% w/v sodium chloride 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

2 Years - 4 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have a confirmed diagnosis of CF
  • Have oxyhemoglobin saturation ≥ 95% prior to randomization

Exclusion Criteria:

  • Have acute intercurrent respiratory infection (cough, wheezing, or new

rhinorrhea or nasal congestion)

  • Have any significant medical condition not related to CF
  • Unable to discontinue use of hypertonic saline

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    denufosol tetrasodium Inhalation Solution

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Intolerability to study drug as measured by: oxyhemoglobin saturation, treatment-emergent cough, and new wheezes or crackles

    Secondary Outcome Measures

    Mean change from pre-dose in oxyhemoglobin saturation at defined times post-dose
    Mean change from baseline in oxyhemoglobin saturation
    Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and/or withdrawals due to TEAEs
    Mean change from pre-dose in pulse and respiratory rate at defined times post-dose
    Mean change from baseline in pulse and respiratory rate
    Incidence of new medical condition(s) or worsening of previous medical condition(s) from baseline

    Full Information

    First Posted
    August 12, 2010
    Last Updated
    December 29, 2014
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01181622
    Brief Title
    A Safety and Tolerability Study of Denufosol in 2-4 Year Olds
    Acronym
    REACH-1
    Official Title
    A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 7-Day Safety and Tolerability Study of Denufosol Tetrasodium Inhalation Solution Administered Via PARI LC® Star in Patients 2 to 4 Years of Age With Cystic Fibrosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2010 (undefined)
    Primary Completion Date
    October 2010 (Actual)
    Study Completion Date
    October 2010 (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 evaluate the safety and tolerability of denufosol 60 mg TID in pediatric CF patients 2 to 4 years of age

    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 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    denufosol tetrasodium Inhalation Solution
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    denufosol tetrasodium Inhalation Solution
    Intervention Description
    60 mg by oral inhalation three times daily
    Intervention Type
    Drug
    Intervention Name(s)
    0.9% w/v sodium chloride solution
    Intervention Description
    0.9% w/v sodium chloride solution by oral inhalation three times daily
    Primary Outcome Measure Information:
    Title
    Intolerability to study drug as measured by: oxyhemoglobin saturation, treatment-emergent cough, and new wheezes or crackles
    Time Frame
    Day 1, Day 7
    Secondary Outcome Measure Information:
    Title
    Mean change from pre-dose in oxyhemoglobin saturation at defined times post-dose
    Time Frame
    Day 1, Day 7
    Title
    Mean change from baseline in oxyhemoglobin saturation
    Time Frame
    Day 7
    Title
    Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and/or withdrawals due to TEAEs
    Time Frame
    Day 7
    Title
    Mean change from pre-dose in pulse and respiratory rate at defined times post-dose
    Time Frame
    Day 1, Day 7
    Title
    Mean change from baseline in pulse and respiratory rate
    Time Frame
    Day 7
    Title
    Incidence of new medical condition(s) or worsening of previous medical condition(s) from baseline
    Time Frame
    Day 7

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    4 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Have a confirmed diagnosis of CF Have oxyhemoglobin saturation ≥ 95% prior to randomization Exclusion Criteria: Have acute intercurrent respiratory infection (cough, wheezing, or new rhinorrhea or nasal congestion) Have any significant medical condition not related to CF Unable to discontinue use of hypertonic saline
    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

    A Safety and Tolerability Study of Denufosol in 2-4 Year Olds

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