Asthma
Conditions
Keywords
asthma
Brief 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.
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.
Interventions
DRUGlevalbuterol
0.5 ml. levalbuterol
DRUGsaline
0.5ml saline
OTHERlevalbuterol MDI
DEVICEaerochamber max
DRUGipratroprium
Sponsors
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment | Tremor assessment will be made on outstretched hands (0 = none, 1+ = fine tremor, barely perceptible, 2+ = obvious tremor). |
| 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 | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All subjects will receive all 5 treatments on 5 different treatment days. Each subject will receive all 5 treatments in the same order. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Customized 18 & older | 10 participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Change in Maximum Forced Expiratory Volume at One Second (FEV1)
Time frame: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment
Population: The same 10 subjects received each of the 5 treatments in the same order. Subjects 1-5 were not included in 6 and 8 hour time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Levalbuterol + Saline in a Breath Actuated Nebulizer | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 2 hour | 26 percentage of change | Standard Deviation 32.23 |
| Levalbuterol + Saline in a Breath Actuated Nebulizer | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 1 hour | 28 percentage of change | Standard Deviation 31.45 |
| Levalbuterol + Saline in a Breath Actuated Nebulizer | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 4 hour | 15 percentage of change | Standard Deviation 29.05 |
| Levalbuterol + Saline in a Breath Actuated Nebulizer | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 30 minutes | 20 percentage of change | Standard Deviation 23.19 |
| Levalbuterol + Saline in a Breath Actuated Nebulizer | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 6 hour | 0 percentage of change | Standard Deviation 18.9 |
| Levalbuterol + Saline in a Breath Actuated Nebulizer | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 8 hour | 1 percentage of change | Standard Deviation 21.26 |
| Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 4 hour | 14 percentage of change | Standard Deviation 18.89 |
| Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 6 hour | 1 percentage of change | Standard Deviation 5.23 |
| Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 8 hour | 9 percentage of change | Standard Deviation 13.1 |
| Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 1 hour | 23 percentage of change | Standard Deviation 19.24 |
| Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 2 hour | 22 percentage of change | Standard Deviation 20.64 |
| Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 30 minutes | 20 percentage of change | Standard Deviation 16.55 |
| Levalbuterol Metered Dose Inhaler (MDI) 2 Puffs | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 30 minutes | 20 percentage of change | Standard Deviation 19.85 |
| Levalbuterol Metered Dose Inhaler (MDI) 2 Puffs | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 6 hour | -5 percentage of change | Standard Deviation 5.98 |
| Levalbuterol Metered Dose Inhaler (MDI) 2 Puffs | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 2 hour | 20 percentage of change | Standard Deviation 23.02 |
| Levalbuterol Metered Dose Inhaler (MDI) 2 Puffs | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 4 hour | 7 percentage of change | Standard Deviation 18.99 |
| Levalbuterol Metered Dose Inhaler (MDI) 2 Puffs | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 1 hour | 19 percentage of change | Standard Deviation 22.57 |
| Levalbuterol Metered Dose Inhaler (MDI) 2 Puffs | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 8 hour | -3 percentage of change | Standard Deviation 7.91 |
| Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 2 hour | 19 percentage of change | Standard Deviation 26.25 |
| Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 30 minutes | 19 percentage of change | Standard Deviation 20.64 |
| Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 1 hour | 20 percentage of change | Standard Deviation 24.23 |
| Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 8 hour | 0 percentage of change | Standard Deviation 15.54 |
| Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 4 hour | 6 percentage of change | Standard Deviation 16.88 |
| Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 6 hour | 1 percentage of change | Standard Deviation 16.05 |
| Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 2 hour | 19 percentage of change | Standard Deviation 21.47 |
| Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 8 hour | -6 percentage of change | Standard Deviation 11.55 |
| Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 6 hour | -6 percentage of change | Standard Deviation 11.68 |
| Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 1 hour | 24 percentage of change | Standard Deviation 22.62 |
| Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 30 minutes | 21 percentage of change | Standard Deviation 21.1 |
| Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 4 hour | 7 percentage of change | Standard Deviation 18.51 |
Secondary
Change in 8 Hour Area-under-the-curve FEV1
Time frame: 0 to 8 hours post dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Levalbuterol + Saline in a Breath Actuated Nebulizer | Change in 8 Hour Area-under-the-curve FEV1 | 5450 percentage of change | Standard Deviation 7039 |
| Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer | Change in 8 Hour Area-under-the-curve FEV1 | 4729 percentage of change | Standard Deviation 4275 |
| Levalbuterol Metered Dose Inhaler (MDI) 2 Puffs | Change in 8 Hour Area-under-the-curve FEV1 | 3893 percentage of change | Standard Deviation 4949 |
| Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs | Change in 8 Hour Area-under-the-curve FEV1 | 3805 percentage of change | Standard Deviation 5253 |
| Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs | Change in 8 Hour Area-under-the-curve FEV1 | 4195 percentage of change | Standard Deviation 4795 |
Secondary
Change in Dyspnea Response as Measured by the University of California, San Diego (UCSD) Dyspnea Scale
Time frame: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment
Population: Data for this outcome measure is not reported because the data was not collected.
Secondary
Change in Heart Rate
Time frame: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment
Population: Data for this outcome measure is not reported because the data was not collected.
Secondary
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).
Time frame: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment
Population: Data for this outcome measure is not reported because the data was not collected.