Aerosolized Beta-Agonist Isomers in Asthma

Duke University

Status and phase: Completed; Phase 4

Conditions: Asthma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02170532

Pro00013822

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 5 patient groups

levalbuterol + saline in a breath actuated nebulizer

Active Comparator group

Description:

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

Treatment:

Drug: levalbuterol

Device: breath actuated nebulizer

Drug: saline

levalbuterol + ipratroprium in a breath actuated nebulizer

Active Comparator group

Description:

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

Treatment:

Drug: levalbuterol

Drug: ipratroprium

Device: breath actuated nebulizer

levalbuterol MDI 2 puffs

Active Comparator group

Description:

levalbuterol metered dose inhaler 2 puffs

Treatment:

Other: levalbuterol MDI

levalbuterol MDI + aerochamber max without pause 2 puffs

Active Comparator group

Description:

levalbuterol MDI + aerochamber max without pause 2 puffs

Treatment:

Other: levalbuterol MDI

Device: aerochamber max

levalbuterol MDI + aerochamber max with 2 second pause 2 puffs

Active Comparator group

Description:

levalbuterol MDI + aerochamber max with 2 second pause 2 puffs

Treatment:

Other: levalbuterol MDI

Device: aerochamber max