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This study was designed to examine the effectiveness of two bronchodilator inhalers in patients who have exercise-induced asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albuterol HFA BOI | Experimental |
| |
| Albuterol HFA MDI | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| albuterol aerosol by HFA MDI | Drug | albuterol HFA MDI 160 mcg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint was mean maximum % change in the baseline absolute forced expiratory volume in 1 second (FEV1) value observed up to 1 hour post-challenge. | Three doses 2-7 days apart |
| Measure | Description | Time Frame |
|---|---|---|
| Mean maximum percent change in the baseline percent predicted FEV1 value observed up to one hour post-challenge | exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes | |
| Mean maximum absolute change in the baseline absolute FEV1 value observed up to one hour post-challenge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David S Pearlman, MD | Colorado Allergy and Asthma Centers, PC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Allergy and Asthma Centers, PC | Denver | Colorado | 80230 | United States | ||
| Colorado Allergy and Asthma Centers, PC |
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| albuterol aerosol by HFA BOI |
| Drug |
albuterol HFA BOI 160 mcg |
|
| placebo aerosol by HFA | Drug | placebo HFA |
|
| exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes |
| Mean percent change in the baseline absolute FEV1 value at each post-challenge time point | exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes |
| Mean absolute change in the baseline absolute FEV1 value at each post-challenge time point | exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes |
| Mean percent change in the baseline percent-predicted FEV1 value at each post-challenge time point | exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes |
| Mean largest negative (or mean smallest positive) percent change in the baseline absolute FEV1 value observed up to one hour post-challenge | exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes |
| Mean largest negative (or mean smallest positive) percent change in the average test-day pre-dose baseline percent predicted FEV1 value observed up to one hour post-challenge | exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes |
| Time to recovery (in minutes) measured from time of completion of exercise challenge to time FEV1 returns to 10% or less of baseline value during the recovery phase | exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes |
| Total changes in FEV1 expressed as the baseline-adjusted area-under-the-effect curve of the percent-predicted FEV1 versus time over 60 minutes (AUEC0 60) | exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes |
| Percentage of patients who are "protected" (maximum percent decrease in the baseline absolute FEV1 <10%), "partially protected" (10 20%), and "unprotected" (>20%). | exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes |
| Englewood |
| Colorado |
| 80112 |
| United States |
| Colorado Allergy and Asthma Centers, PC | Lakewood | Colorado | 80401 | United States |
| ID | Term |
|---|---|
| D001250 | Asthma, Exercise-Induced |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D000092202 | Exercise-Induced Allergies |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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