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Early Airway Response to Allergen in Asthmatics (MK-0000-176)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Nedocromil
Comparator: Montelukast
Comparator: Mometasone
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of mild to moderate Asthma
  • In good general health (except for asthma)
  • Stable and free of respiratory infection
  • Nonsmoker
  • Females highly unlikely to conceive (surgically sterilized, postmenopausal, or agrees to use 2 acceptable methods of birth control)

Exclusion Criteria:

  • Nursing mother
  • Recent or ongoing upper or lower respiratory tract infection
  • Unable to refrain from or anticipates the use of any prescription and non-prescription drugs
  • Consumes excessive amounts of alcohol or caffeine
  • History of stroke, chronic seizures, or major neurological disorder
  • History of cancer
  • Received a vaccination within the past 3 weeks

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Placebo

    Montelukast

    Nedocromil

    Mometasone

    Arm Description

    Placebo

    Montelukast

    Nedocromil

    Mometasone

    Outcomes

    Primary Outcome Measures

    Change in Forced Expiratory Volume in 1 Second (FEV1)
    Maximal percent drop in FEV1 at 20 minutes post allergen challenge
    Change in Plasma 9α-11β-PGF2 (9P) at 5 Minutes
    Fold change over baseline of plasma 9P at 5 minutes post-allergen challenge
    Change in Plasma 9P at 20 Minutes
    Fold change over baseline of plasma 9P at 20 minutes post-allergen challenge

    Secondary Outcome Measures

    Allergen-induced Changes in Urinary 9P
    Fold change over baseline in Urinary 9P at 2 hours post allergen challenge
    Allergen-induced Changes in Urinary Leukotriene (LT) E4
    Fold change over baseline in urinary LTE4 at 2 hours post-allergen challenge
    Allergen-induced Concentrations of Sputum LTC4
    Concentrations of LTC4 in sputum at 2 hours post-allergen challenge
    Allergen-induced Concentrations of Sputum LTD4
    Concentrations of LTD4 in sputum at 2 hours post-allergen challenge
    Allergen-induced Concentrations of Sputum LTE4
    Concentrations of LTE4 in sputum at 2 hours post-allergen challenge

    Full Information

    First Posted
    February 1, 2010
    Last Updated
    September 3, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01061333
    Brief Title
    Early Airway Response to Allergen in Asthmatics (MK-0000-176)
    Official Title
    A Two-Part, Randomized, Placebo-Controlled, Crossover Trial to Evaluate the Differential Effects of Inhaled Nedocromil, Oral Montelukast, and Inhaled Mometasone on Markers of the Early Airway Response to Allergen in Asthmatics
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2010 (undefined)
    Primary Completion Date
    February 2011 (Actual)
    Study Completion Date
    March 2011 (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 assess the Early Airway Response (EAR) associated change in forced expiratory volume in one second (FEV1) and plasma 9α-11ß-PGF2 ('9P') after single dose pretreatment of nedocromil, montelukast, and mometasone.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Experimental
    Arm Description
    Placebo
    Arm Title
    Montelukast
    Arm Type
    Experimental
    Arm Description
    Montelukast
    Arm Title
    Nedocromil
    Arm Type
    Experimental
    Arm Description
    Nedocromil
    Arm Title
    Mometasone
    Arm Type
    Experimental
    Arm Description
    Mometasone
    Intervention Type
    Drug
    Intervention Name(s)
    Nedocromil
    Intervention Description
    Nedocromil 4 mg, as metered dose inhaler 1 hour prior to allergen challenge
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Montelukast
    Other Intervention Name(s)
    Singulair
    Intervention Description
    Montelukast single 10 mg tablet administered 2 hours prior to allergen challenge
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Mometasone
    Intervention Description
    Mometasone furoate 400 mcg by twisthaler, administered 2 hours prior to allergen challenge
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Mometasone placebo twisthaler, Nedocromil placebo metered dose inhaler, Montelukast placebo tablet
    Primary Outcome Measure Information:
    Title
    Change in Forced Expiratory Volume in 1 Second (FEV1)
    Description
    Maximal percent drop in FEV1 at 20 minutes post allergen challenge
    Time Frame
    Pre-allergen challenge and 20 minutes after allergen challenge
    Title
    Change in Plasma 9α-11β-PGF2 (9P) at 5 Minutes
    Description
    Fold change over baseline of plasma 9P at 5 minutes post-allergen challenge
    Time Frame
    Pre-allergen challenge and 5 minutes post allergen challenge
    Title
    Change in Plasma 9P at 20 Minutes
    Description
    Fold change over baseline of plasma 9P at 20 minutes post-allergen challenge
    Time Frame
    Pre-allergen challenge and 20 minutes post allergen challenge
    Secondary Outcome Measure Information:
    Title
    Allergen-induced Changes in Urinary 9P
    Description
    Fold change over baseline in Urinary 9P at 2 hours post allergen challenge
    Time Frame
    Baseline and 2 hours post allergen challenge
    Title
    Allergen-induced Changes in Urinary Leukotriene (LT) E4
    Description
    Fold change over baseline in urinary LTE4 at 2 hours post-allergen challenge
    Time Frame
    Baseline and 2 hours post allergen challenge
    Title
    Allergen-induced Concentrations of Sputum LTC4
    Description
    Concentrations of LTC4 in sputum at 2 hours post-allergen challenge
    Time Frame
    2 hours post allergen challenge
    Title
    Allergen-induced Concentrations of Sputum LTD4
    Description
    Concentrations of LTD4 in sputum at 2 hours post-allergen challenge
    Time Frame
    2 hours post allergen challenge
    Title
    Allergen-induced Concentrations of Sputum LTE4
    Description
    Concentrations of LTE4 in sputum at 2 hours post-allergen challenge
    Time Frame
    2 hours post allergen challenge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: History of mild to moderate Asthma In good general health (except for asthma) Stable and free of respiratory infection Nonsmoker Females highly unlikely to conceive (surgically sterilized, postmenopausal, or agrees to use 2 acceptable methods of birth control) Exclusion Criteria: Nursing mother Recent or ongoing upper or lower respiratory tract infection Unable to refrain from or anticipates the use of any prescription and non-prescription drugs Consumes excessive amounts of alcohol or caffeine History of stroke, chronic seizures, or major neurological disorder History of cancer Received a vaccination within the past 3 weeks
    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

    Early Airway Response to Allergen in Asthmatics (MK-0000-176)

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