Phase 4
Completed N=10
Aerosolized Beta-Agonist Isomers in Asthma
Source: ClinicalTrials.gov NCT02170532 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcomePrimary: Change in Maximum Forced Expiratory Volume at One Second (FEV1) — 20; 20; 20; 19 percentage of change
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.
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 |
— | — |
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
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. Informational only — not medical advice.