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Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study (OARS)

Primary Purpose

Acute Asthma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Albuterol
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Asthma focused on measuring Asthma, Acute asthma, Pediatrics

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Doctor diagnosed asthma
  • Acute asthma exacerbation
  • Treatment with systemic corticosteroids and nebulized albuterol
  • Ages 5 to 17 years

Exclusion Criteria:

  • Other acute or chronic lung disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    Nebulized albuterol 10mg/hr continuous

    10mg/hr pulsed

    25mg/hr continuous

    25mg/hr pulsed

    Arm Description

    Active control arm, 10mg/hr continuous.

    Experimental 10mg/hr pulsed albuterol regimen.

    Experimental 25mg/hr continuous albuterol.

    Experimental 25mg/hr pulsed albuterol

    Outcomes

    Primary Outcome Measures

    %FEV1
    % predicted forced expiratory volume in 1-second as a measure of airway obstruction

    Secondary Outcome Measures

    Full Information

    First Posted
    September 3, 2010
    Last Updated
    September 4, 2017
    Sponsor
    Vanderbilt University Medical Center
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01196377
    Brief Title
    Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study
    Acronym
    OARS
    Official Title
    Personalized Medicine, Biomarker-based Study of Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2010 (undefined)
    Primary Completion Date
    October 2010 (Actual)
    Study Completion Date
    October 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Vanderbilt University Medical Center
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Our overall objective is to model a pediatric Acute Asthma Clinical Decision Rule (ADR) for personalized medicine by identification of treatment-response phenotypes that are important determinants of outcome. The Specific Aim of this study is to determine the feasibility of this approach by enrolling a pilot cohort of 16 participants in this DBRCT of 4 different albuterol treatment regimens, 2 of which will use 10mg/hr and 2 of which will use 25mg/hr. Within these dosages there will be a pulsed-treatment regimen and a continuous regimen.
    Detailed Description
    The objective of this study is to determine the feasibility of this approach by enrolling a pilot cohort of 16 participants in this DBRCT of 4 different albuterol treatment regimens, 2 of which will use 10mg/hr and 2 of which will use 25mg/hr. Participants are randomized in randomly permuted blocks of four. Within these dosages there will be a pulsed-treatment regimen and a continuous regimen.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Asthma
    Keywords
    Asthma, Acute asthma, Pediatrics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Nebulized albuterol 10mg/hr continuous
    Arm Type
    Active Comparator
    Arm Description
    Active control arm, 10mg/hr continuous.
    Arm Title
    10mg/hr pulsed
    Arm Type
    Experimental
    Arm Description
    Experimental 10mg/hr pulsed albuterol regimen.
    Arm Title
    25mg/hr continuous
    Arm Type
    Experimental
    Arm Description
    Experimental 25mg/hr continuous albuterol.
    Arm Title
    25mg/hr pulsed
    Arm Type
    Experimental
    Arm Description
    Experimental 25mg/hr pulsed albuterol
    Intervention Type
    Drug
    Intervention Name(s)
    Albuterol
    Other Intervention Name(s)
    proventil
    Intervention Description
    Nebulized albuterol
    Primary Outcome Measure Information:
    Title
    %FEV1
    Description
    % predicted forced expiratory volume in 1-second as a measure of airway obstruction
    Time Frame
    2 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Doctor diagnosed asthma Acute asthma exacerbation Treatment with systemic corticosteroids and nebulized albuterol Ages 5 to 17 years Exclusion Criteria: Other acute or chronic lung disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Donald H Arnold, MD, MPH
    Organizational Affiliation
    Vanderbilt University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study

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