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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: levalbuterol; Drug: saline; Device: breath actuated nebulizer; Drug: ipratroprium; Other: levalbuterol MDI; Device: aerochamber max

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Neil MacIntyre, MD, Duke University

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: June 19, 2014
• First Submitted That Met QC Criteria: June 19, 2014
• First Posted (Estimate): June 23, 2014

Study Record Updates

• Last Update Posted (Estimate): August 13, 2014
• Last Update Submitted That Met QC Criteria: August 11, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol
• Other Study ID Numbers: Pro00013822