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OpenTrials
Completed

NCT Number: NCT02170532

Aerosolized Beta-Agonist Isomers in Asthma

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levalbuterol

Drug

0.5 ml. levalbuterol

Saline

Drug

0.5ml saline

levalbuterol MDI

Other

breath actuated nebulizer

Device

aerochamber max

Device

ipratroprium

Drug

Primary outcomes

  1. 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 outcomes

  1. Change in 8 Hour Area-under-the-curve FEV1

    Time frame: 0 to 8 hours post dose

  2. Change in Heart Rate

    Time frame: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment

  3. Change in Tremor Assessment Measured by a Scale

    Time frame: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment

    Tremor assessment will be made on outstretched hands (0 = none, 1+ = fine tremor, barely perceptible, 2+ = obvious tremor).

  4. 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jun 23, 2014
Registry last updated
Aug 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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