Aerosolized Beta-Agonist Isomers in Asthma

Phase 4

Completed

Interventions: Drug: levalbuterol
Other: levalbuterol MDI
Device: aerochamber max
Drug: saline
Device: breath actuated nebulizer
Drug: ipratroprium

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
levalbuterol + saline in a breath actuated nebulizer	levalbuterol	0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer
levalbuterol + saline in a breath actuated nebulizer	breath actuated nebulizer	0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer
levalbuterol MDI + aerochamber max with 2 second pause 2 puffs	aerochamber max	levalbuterol MDI + aerochamber max with 2 second pause 2 puffs
levalbuterol + saline in a breath actuated nebulizer	saline	0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer
levalbuterol + ipratroprium in a breath actuated nebulizer	ipratroprium	0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer
levalbuterol MDI 2 puffs	levalbuterol MDI	levalbuterol metered dose inhaler 2 puffs
levalbuterol MDI + aerochamber max with 2 second pause 2 puffs	levalbuterol MDI	levalbuterol MDI + aerochamber max with 2 second pause 2 puffs
levalbuterol + ipratroprium in a breath actuated nebulizer	breath actuated nebulizer	0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer
levalbuterol MDI + aerochamber max without pause 2 puffs	levalbuterol MDI	levalbuterol MDI + aerochamber max without pause 2 puffs
levalbuterol MDI + aerochamber max without pause 2 puffs	aerochamber max	levalbuterol MDI + aerochamber max without pause 2 puffs
levalbuterol + ipratroprium in a breath actuated nebulizer	levalbuterol	0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	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).
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