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Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
denufosol tetrasodium (INS37217)
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring cystic fibrosis

Eligibility Criteria

8 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: confirmed diagnosis of CF FEV1 greater than or equal to 75% of predicted normal for age, gender, and height oxyhemoglobin saturation greater than or equal to 90% clinically stable Exclusion Criteria: abnormal renal or liver function clinically significant findings atypical for moderate cystic fibrosis

Sites / Locations

    Outcomes

    Primary Outcome Measures

    lung function
    respiratory symptoms
    sputum weight
    pulmonary exacerbations
    measures of lung characteristics

    Secondary Outcome Measures

    safety measures

    Full Information

    First Posted
    March 6, 2003
    Last Updated
    January 28, 2015
    Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    Cystic Fibrosis Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00056147
    Brief Title
    Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease
    Official Title
    Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of INS37217 Inhalation Solution in Subjects With Mild to Moderate Cystic Fibrosis Lung Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2003 (undefined)
    Primary Completion Date
    February 2004 (Actual)
    Study Completion Date
    February 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    Cystic Fibrosis Foundation

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the safety and effectiveness of multiple dosages of INS37217 compared to placebo over 28 days in subjects with mild to moderate cystic fibrosis (CF) lung disease. Study drug will be administered through a nebulizer (a device that delivers medication as a mist by breathing it in).
    Detailed Description
    The purpose of this study is to: assess the safety and efficacy of multiple dose levels of INS37217 compared to placebo over 28 days in subjects with mild to moderate CF lung disease; explore evidence of activity of INS37217 and placebo administered via PARI LC STAR nebulizer; identify dose(s) that will be studied in subsequent trials.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    denufosol tetrasodium (INS37217)
    Primary Outcome Measure Information:
    Title
    lung function
    Title
    respiratory symptoms
    Title
    sputum weight
    Title
    pulmonary exacerbations
    Title
    measures of lung characteristics
    Secondary Outcome Measure Information:
    Title
    safety measures

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: confirmed diagnosis of CF FEV1 greater than or equal to 75% of predicted normal for age, gender, and height oxyhemoglobin saturation greater than or equal to 90% clinically stable Exclusion Criteria: abnormal renal or liver function clinically significant findings atypical for moderate cystic fibrosis
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amy Schaberg, BSN
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17446337
    Citation
    Deterding RR, Lavange LM, Engels JM, Mathews DW, Coquillette SJ, Brody AS, Millard SP, Ramsey BW; Cystic Fibrosis Therapeutics Development Network and the Inspire 08-103 Working Group. Phase 2 randomized safety and efficacy trial of nebulized denufosol tetrasodium in cystic fibrosis. Am J Respir Crit Care Med. 2007 Aug 15;176(4):362-9. doi: 10.1164/rccm.200608-1238OC. Epub 2007 Apr 19.
    Results Reference
    result

    Learn more about this trial

    Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease

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