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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| levalbuterol + saline in a breath actuated nebulizer | Active Comparator | 0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer |
|
| levalbuterol + ipratroprium in a breath actuated nebulizer | Active Comparator | 0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer |
|
| levalbuterol MDI 2 puffs | Active Comparator | levalbuterol metered dose inhaler 2 puffs |
|
| levalbuterol MDI + aerochamber max without pause 2 puffs | Active Comparator | levalbuterol MDI + aerochamber max without pause 2 puffs |
|
| levalbuterol MDI + aerochamber max with 2 second pause 2 puffs | Active Comparator | levalbuterol MDI + aerochamber max with 2 second pause 2 puffs |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levalbuterol | Drug | 0.5 ml. levalbuterol |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil MacIntyre, MD | Duke University | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All subjects will receive all 5 treatments on 5 different treatment days. Each subject will receive all 5 treatments in the same order.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Maximum Forced Expiratory Volume at One Second (FEV1) | 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. | Posted | Mean | Standard Deviation | percentage of change | Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neil MacIntyre, MD | Duke University Medical Center | (919) 681-2720 | macin001@mc.duke.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D064412 | Levalbuterol |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 |
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| saline | Drug | 0.5ml saline |
|
| levalbuterol MDI | Other |
|
| breath actuated nebulizer | Device |
|
| aerochamber max | Device |
|
| ipratroprium | Drug |
|
| 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). |
| Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment |
| 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 |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Levalbuterol Metered Dose Inhaler (MDI) 2 Puffs | levalbuterol metered dose inhaler (MDI) 2 puffs levalbuterol MDI |
| OG003 | Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs | levalbuterol metered-dose inhaler (MDI) + aerochamber max without pause 2 puffs levalbuterol MDI aerochamber max |
| OG004 | Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs | levalbuterol metered dose inhaler (MDI) + aerochamber max with 2 second pause 2 puffs levalbuterol MDI aerochamber max |
|
|
| Secondary | Change in 8 Hour Area-under-the-curve FEV1 | Posted | Mean | Standard Deviation | percentage of change | 0 to 8 hours post dose |
|
|
|
| Secondary | Change in Heart Rate | Data for this outcome measure is not reported because the data was not collected. | Posted | Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment |
|
|
| 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). | Data for this outcome measure is not reported because the data was not collected. | Posted | Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment |
|
|
| Secondary | Change in Dyspnea Response as Measured by the University of California, San Diego (UCSD) Dyspnea Scale | Data for this outcome measure is not reported because the data was not collected. | Posted | Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |