Phase 4 N=10 Treatment

Aerosolized Beta-Agonist Isomers in Asthma

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT02170532 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcome: Primary: Change in Maximum Forced Expiratory Volume at One Second (FEV1) — 20; 20; 20; 19 percentage of change

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: levalbuterol (Drug); saline (Drug); levalbuterol MDI (Other); breath actuated nebulizer (Device); aerochamber max (Device); ipratroprium (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Jul 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Maximum Forced Expiratory Volume at One Second (FEV1)	20; 20; 20; 19; 21; 28	—
SECONDARY Change in 8 Hour Area-under-the-curve FEV1	5450; 4729; 3893; 3805; 4195	—
SECONDARY Change in Heart Rate	—	—
SECONDARY Change in Tremor Assessment Measured by a Scale	—	—
SECONDARY Change in Dyspnea Response as Measured by the University of California, San Diego (UCSD) Dyspnea Scale	—	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02170532). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.