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 FEV1Change 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
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