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Study of Biomarkers of Airway Inflammation (0000-128)

Primary Purpose

Airway Inflammation

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
fluticasone propionate
Comparator: Placebo to fluticasone
Comparator: Lipopolysaccharide (LPS)
Comparator: albuterol
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Airway Inflammation focused on measuring Sputum inflammatory biomarkers

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Female subjects who can have children must have a negative pregnancy test at screening and agree to use two methods of birth control throughout the study
  • Male subjects with female partner(s) who can have children agree to use an acceptable method of birth control throughout the study
  • Subject is a nonsmoker
  • Subject is in generally good health
  • Subject is willing to comply with the diet, alcohol, and caffeine study restrictions

Exclusion Criteria:

  • Subject is a nursing mother
  • Subject has taken oral corticosteroids within 8 weeks or inhaled/nasal corticosteroids within 4 weeks of screening
  • Subject has nasal polyps, recent nasal surgery, or an ongoing upper or lower respiratory tract infection
  • Subject has a recent history of allergic rhinitis at screening
  • Subject has any respiratory disease at screening
  • Subject has daily phlegm or a chronic cough
  • Subject is unable to refrain from the use of any prescription or non-prescription drugs or herbal remedies during the study
  • Subject consumes excessive amounts of alcohol or caffeine
  • Subject has had major surgery, or donated or lost 1 unit of blood within 4 weeks of screening
  • Subject has a history of stroke, seizures, or major neurological disorders
  • Subject regularly uses illicit drugs or has a history of drug/alcohol abuse
  • Subject received a vaccination within 3 weeks of screening

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Arm Label

    1

    2

    3

    Arm Description

    Placebo

    Fluticasone 440 mcg

    Fluticasone 1980 mcg

    Outcomes

    Primary Outcome Measures

    Sputum percent neutrophils

    Secondary Outcome Measures

    Sputum absolute neutrophils (per mL)
    Sputum levels of IL1beta and IL8
    Sputum mRNA expression levels of CD14 and IL1beta

    Full Information

    First Posted
    March 25, 2009
    Last Updated
    July 22, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00869596
    Brief Title
    Study of Biomarkers of Airway Inflammation (0000-128)
    Official Title
    A Randomized Clinical Trial to Assess the Effects of Inhaled Fluticasone on Sputum Neutrophils After Low-dose Inhaled Endotoxin Challenge in Healthy Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2009 (undefined)
    Primary Completion Date
    September 2009 (Actual)
    Study Completion Date
    September 2009 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will evaluate the effects of inhaled fluticasone on cell counts and inflammatory mediators measured in sputum of healthy volunteers following exposure to inhaled lipopolysaccharide.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Airway Inflammation
    Keywords
    Sputum inflammatory biomarkers

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Fluticasone 440 mcg
    Arm Title
    3
    Arm Type
    Active Comparator
    Arm Description
    Fluticasone 1980 mcg
    Intervention Type
    Drug
    Intervention Name(s)
    fluticasone propionate
    Intervention Description
    Single dose of fluticasone 440 mcg (2 x 220 mcg) or 1980 mcg (9 x 220 mcg) by metered dose inhaler in two of three treatment periods
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo to fluticasone
    Intervention Description
    Single dose of placebo to fluticasone (9 x 0 mcg) by metered dose inhaler in one of three treatment periods
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Lipopolysaccharide (LPS)
    Intervention Description
    20,000 EU LPS by inhalation 1 hour postdose of fluticasone or placebo in each of three treatment periods
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: albuterol
    Intervention Description
    Albuterol two 100 mcg inhalations by metered dose inhaler prior to sputum induction at screening, twice during each of the three treatment periods, and at the post-study follow up visit.
    Primary Outcome Measure Information:
    Title
    Sputum percent neutrophils
    Time Frame
    6 hours following inhaled LPS challenge
    Secondary Outcome Measure Information:
    Title
    Sputum absolute neutrophils (per mL)
    Time Frame
    6 hours following inhaled LPS challenge
    Title
    Sputum levels of IL1beta and IL8
    Time Frame
    6 hours following inhaled LPS challenge
    Title
    Sputum mRNA expression levels of CD14 and IL1beta
    Time Frame
    6 hours following inhaled LPS challenge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Female subjects who can have children must have a negative pregnancy test at screening and agree to use two methods of birth control throughout the study Male subjects with female partner(s) who can have children agree to use an acceptable method of birth control throughout the study Subject is a nonsmoker Subject is in generally good health Subject is willing to comply with the diet, alcohol, and caffeine study restrictions Exclusion Criteria: Subject is a nursing mother Subject has taken oral corticosteroids within 8 weeks or inhaled/nasal corticosteroids within 4 weeks of screening Subject has nasal polyps, recent nasal surgery, or an ongoing upper or lower respiratory tract infection Subject has a recent history of allergic rhinitis at screening Subject has any respiratory disease at screening Subject has daily phlegm or a chronic cough Subject is unable to refrain from the use of any prescription or non-prescription drugs or herbal remedies during the study Subject consumes excessive amounts of alcohol or caffeine Subject has had major surgery, or donated or lost 1 unit of blood within 4 weeks of screening Subject has a history of stroke, seizures, or major neurological disorders Subject regularly uses illicit drugs or has a history of drug/alcohol abuse Subject received a vaccination within 3 weeks of screening
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study of Biomarkers of Airway Inflammation (0000-128)

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