Aerosolized Beta-Agonist Isomers in Asthma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Aerosolized Beta-Agonist Isomers in Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: levalbuterol
* Drug: saline
* Other: levalbuterol MDI
* Device: breath actuated nebulizer
* Device: aerochamber max
* Drug: ipratroprium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: levalbuterol + saline in a breath actuated nebulizer<br>0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer | Drug: levalbuterol<br>* 0.5 ml. levalbuterol<br>Drug: saline<br>* 0.5ml saline<br>Device: breath actuated nebulizer<br> <br> |
| Active Comparator: levalbuterol + ipratroprium in a breath actuated nebulizer<br>0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer | Drug: levalbuterol<br>* 0.5 ml. levalbuterol<br>Device: breath actuated nebulizer<br> <br> Drug: ipratroprium<br> <br> |
| Active Comparator: levalbuterol MDI 2 puffs<br>levalbuterol metered dose inhaler 2 puffs | Other: levalbuterol MDI<br> <br> |
| Active Comparator: levalbuterol MDI + aerochamber max without pause 2 puffs<br>levalbuterol MDI + aerochamber max without pause 2 puffs | Other: levalbuterol MDI<br> <br> Device: aerochamber max<br> <br> |
| Active Comparator: levalbuterol MDI + aerochamber max with 2 second pause 2 puffs<br>levalbuterol MDI + aerochamber max with 2 second pause 2 puffs | Other: levalbuterol MDI<br> <br> Device: aerochamber max<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Maximum Forced Expiratory Volume at One Second (FEV1) |  | Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 8 Hour Area-under-the-curve FEV1 |  | 0 to 8 hours post dose | 
| Change in Heart Rate |  | Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment | 
| 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). | Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment | 
| Change in Dyspnea Response as Measured by the University of California, San Diego (UCSD) Dyspnea Scale |  | Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma