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This study was designed to examine the effectiveness of a breath-operated albuterol inhaler in asthma patients who have difficulty using their standard "press-and-breathe" inhaler.
This was a single-center, randomized, open-label, active-controlled, 2-period, 2-sequence, single dose-dose, crossover comparison of the ability of Albuterol BOI-HFA to produce bronchodilation relative to that produced by to albuterol MDI-HFA in at least 12 asthmatics with poor inhaler coordinating ability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albuterol HFA-BOI | Experimental |
| |
| Albuterol HFA-MDI | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albuterol HFA-BOI | Drug | Albuterol HFA breath operated inhaler, 90 mcg/sprau |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in SGaw (A measure of the change in specific airway conductance - how hard it is to get air into the lungs) | Pre-dose and +120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| The area-under-the-effect curve of change in SGaw from basline over time | Pre-dose and +120 minutes | |
| The maximum increase in SGaw from baseline over two hours | Baseline through +120 minutes | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harold Nelson, MD | National Jewish Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Medical and Research Ceter | Denver | Colorado | 80206 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Nelson HS, Wenzel SE, Weisfeld L, Llorens L, Atkinson DC, Stahl EG. Comparison of single-dose efficacy of albuterol-hydrofloroalkane breath-activated inhaler and Nelson HS, Wenzel SE, Weisfeld L, Llorens L, Atkinson DC, Stahl EG. Comparison of single-dose efficacy of albuterol-hydrofloroalkane metered-dose inhaler in asthma patients with poor inhaler coordinating ability. Chest 2008;134:92003S (Abstracts, ACCP Annual Meeting, October 25-30, 2008, Philadelphia, Pennsylvania, USA. |
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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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| Albuterol HFA-MDI |
| Drug |
Albuterol HFA multi-dose inhaler |
|
|
| Time in hours to the maximum increase in SGaw from baseline |
| Baseline through +120 minutes post-dose |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |