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Aerosolized Beta-Agonist Isomers in Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
levalbuterol
saline
levalbuterol MDI
breath actuated nebulizer
aerochamber max
ipratroprium
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • stable mild to moderate persistent asthma as defined by the National Asthma Education and Prevention Program
  • greater than 18 years of age
  • requiring bronchodilator therapy either routinely or on a as needed (PRN)basis
  • stable with respect to respiratory disease and at least four weeks removed from the most recent acute exacerbation of the disease
  • patients may or may not be on inhaled corticosteroids

Exclusion Criteria:

  • no unstable cardiovascular symptoms
  • no unstable angina
  • must be at least four weeks removed from an acute coronary syndrome

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    levalbuterol + saline in a breath actuated nebulizer

    levalbuterol + ipratroprium in a breath actuated nebulizer

    levalbuterol MDI 2 puffs

    levalbuterol MDI + aerochamber max without pause 2 puffs

    levalbuterol MDI + aerochamber max with 2 second pause 2 puffs

    Arm Description

    0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer

    0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer

    levalbuterol metered dose inhaler 2 puffs

    levalbuterol MDI + aerochamber max without pause 2 puffs

    levalbuterol MDI + aerochamber max with 2 second pause 2 puffs

    Outcomes

    Primary Outcome Measures

    Change in Maximum Forced Expiratory Volume at One Second (FEV1)

    Secondary Outcome Measures

    Change in 8 Hour Area-under-the-curve FEV1
    Change in Heart Rate
    Change in Tremor Assessment Measured by a Scale
    Tremor assessment will be made on outstretched hands (0 = none, 1+ = fine tremor, barely perceptible, 2+ = obvious tremor).
    Change in Dyspnea Response as Measured by the University of California, San Diego (UCSD) Dyspnea Scale

    Full Information

    First Posted
    June 19, 2014
    Last Updated
    August 11, 2014
    Sponsor
    Duke University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02170532
    Brief Title
    Aerosolized Beta-Agonist Isomers in Asthma
    Official Title
    Aerosolized Beta-Agonist Isomers in Asthma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2007 (undefined)
    Primary Completion Date
    July 2009 (Actual)
    Study Completion Date
    July 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Duke University

    4. Oversight

    5. Study Description

    Brief Summary
    Dr. MacIntyre and his colleagues are studying inhaled medications in asthma. There are two new medications that have been approved by the United States Food and Drug Administration (FDA): levalbuterol and formoterol. Both of these drugs are similar to standard asthma bronchodilator drugs but offer theoretical advantages in terms of fewer side effects. There are also newer devices to deliver these medications into the lungs: breath actuated nebulizers (BANs) and non-static chambers (Aerochamber-max) that can be used with metered dose inhalers (MDIs or "puffers"). The purpose of this study is to deliver these new medications using several different devices and measuring lung function, heart rate, and sensations of breathlessness.
    Detailed Description
    Patients will be studied on five separate mornings. The duration of the study and frequency of the visits will be solely dependant on the subject availability. Each subject will receive all 5 treatments in the same order.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    levalbuterol + saline in a breath actuated nebulizer
    Arm Type
    Active Comparator
    Arm Description
    0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer
    Arm Title
    levalbuterol + ipratroprium in a breath actuated nebulizer
    Arm Type
    Active Comparator
    Arm Description
    0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer
    Arm Title
    levalbuterol MDI 2 puffs
    Arm Type
    Active Comparator
    Arm Description
    levalbuterol metered dose inhaler 2 puffs
    Arm Title
    levalbuterol MDI + aerochamber max without pause 2 puffs
    Arm Type
    Active Comparator
    Arm Description
    levalbuterol MDI + aerochamber max without pause 2 puffs
    Arm Title
    levalbuterol MDI + aerochamber max with 2 second pause 2 puffs
    Arm Type
    Active Comparator
    Arm Description
    levalbuterol MDI + aerochamber max with 2 second pause 2 puffs
    Intervention Type
    Drug
    Intervention Name(s)
    levalbuterol
    Intervention Description
    0.5 ml. levalbuterol
    Intervention Type
    Drug
    Intervention Name(s)
    saline
    Intervention Description
    0.5ml saline
    Intervention Type
    Other
    Intervention Name(s)
    levalbuterol MDI
    Intervention Type
    Device
    Intervention Name(s)
    breath actuated nebulizer
    Intervention Type
    Device
    Intervention Name(s)
    aerochamber max
    Intervention Type
    Drug
    Intervention Name(s)
    ipratroprium
    Primary Outcome Measure Information:
    Title
    Change in Maximum Forced Expiratory Volume at One Second (FEV1)
    Time Frame
    Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment
    Secondary Outcome Measure Information:
    Title
    Change in 8 Hour Area-under-the-curve FEV1
    Time Frame
    0 to 8 hours post dose
    Title
    Change in Heart Rate
    Time Frame
    Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment
    Title
    Change in Tremor Assessment Measured by a Scale
    Description
    Tremor assessment will be made on outstretched hands (0 = none, 1+ = fine tremor, barely perceptible, 2+ = obvious tremor).
    Time Frame
    Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment
    Title
    Change in Dyspnea Response as Measured by the University of California, San Diego (UCSD) Dyspnea Scale
    Time Frame
    Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: stable mild to moderate persistent asthma as defined by the National Asthma Education and Prevention Program greater than 18 years of age requiring bronchodilator therapy either routinely or on a as needed (PRN)basis stable with respect to respiratory disease and at least four weeks removed from the most recent acute exacerbation of the disease patients may or may not be on inhaled corticosteroids Exclusion Criteria: no unstable cardiovascular symptoms no unstable angina must be at least four weeks removed from an acute coronary syndrome
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Neil MacIntyre, MD
    Organizational Affiliation
    Duke University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Aerosolized Beta-Agonist Isomers in Asthma

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