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Aerosolized Beta-Agonist Isomers in Asthma

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: levalbuterol (Drug); saline (Drug); levalbuterol MDI (Other); breath actuated nebulizer (Device); aerochamber max (Device); ipratroprium (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
Neil MacIntyre, MD, Principal Investigator, Affiliation: Duke University

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.

Clinical Details

Official title: Aerosolized Beta-Agonist Isomers in Asthma

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in Maximum Forced Expiratory Volume at One Second (FEV1)

Secondary outcome:

Change in 8 Hour Area-under-the-curve FEV1

Change in Heart Rate

Change in Tremor Assessment Measured by a Scale

Change in Dyspnea Response as Measured by the University of California, San Diego (UCSD) Dyspnea Scale

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: July 2007
Last updated: August 11, 2014

Page last updated: August 23, 2015

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