Aerosolized Beta-Agonist Isomers in Asthma

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-07-31

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.

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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.

Conditions

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Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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levalbuterol + saline in a breath actuated nebulizer

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

Group Type ACTIVE_COMPARATOR

levalbuterol

Intervention Type DRUG

0.5 ml. levalbuterol

saline

Intervention Type DRUG

0.5ml saline

breath actuated nebulizer

Intervention Type DEVICE

levalbuterol + ipratroprium in a breath actuated nebulizer

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

Group Type ACTIVE_COMPARATOR

levalbuterol

Intervention Type DRUG

0.5 ml. levalbuterol

breath actuated nebulizer

Intervention Type DEVICE

ipratroprium

Intervention Type DRUG

levalbuterol MDI 2 puffs

levalbuterol metered dose inhaler 2 puffs

Group Type ACTIVE_COMPARATOR

levalbuterol MDI

Intervention Type OTHER

levalbuterol MDI + aerochamber max without pause 2 puffs

Group Type ACTIVE_COMPARATOR

levalbuterol MDI

Intervention Type OTHER

aerochamber max

Intervention Type DEVICE

levalbuterol MDI + aerochamber max with 2 second pause 2 puffs

Group Type ACTIVE_COMPARATOR

levalbuterol MDI

Intervention Type OTHER

aerochamber max

Intervention Type DEVICE

Interventions

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levalbuterol

0.5 ml. levalbuterol

Intervention Type DRUG

saline

0.5ml saline

Intervention Type DRUG

levalbuterol MDI

Intervention Type OTHER

breath actuated nebulizer

Intervention Type DEVICE

aerochamber max

Intervention Type DEVICE

ipratroprium

Intervention Type DRUG

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