Efficacy of Inhaled Albuterol Spiromax® in Subjects With Persistent Asthma With Steady State Pharmacokinetics



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - Any
Updated:11/30/-0001
Start Date:December 2012
End Date:September 2013
Contact:Teva US Medical Information
Phone:1-800-896-5855

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A 12-week Comparison of the Efficacy and Safety and Steady-state Pharmacokinetics of Albuterol Spiromax® and Placebo in Subjects 12 Years


The primary objective of this study is to evaluate the efficacy of Albuterol Spiromax®
versus placebo in subjects with persistent asthma.


Inclusion Criteria:

- Written informed consent/assent

- At least 12 years of age at screening

- General good health

- Persistent asthma, with an FEV1 50-80% predicted

- Ability to perform spirometry in an acceptable manner as per protocol guidelines

- Other inclusion criteria apply

Exclusion Criteria:

- A known hypersensitivity to albuterol or any of the excipients in the formulations.

- History of a respiratory infection or disorder that has not resolved within 1 week
preceding the Screening Visit (SV).

- History of life-threatening asthma that is defined for this protocol as an asthma
episode that required intubation.

- Any asthma exacerbation requiring oral corticosteroids within 3 months of the SV. A
subject must not have had any hospitalization for asthma within 6 months prior to the
SV.

- Hospitalization due to asthma exacerbation 2 or more times in the past year

- Initiation of immunotherapy or dose escalation during the study period

- Other exclusion criteria apply.
We found this trial at
33
sites
Baltimore, Maryland
344
mi
from 43215
Baltimore, MD
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798
mi
from 43215
Bangor, ME
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Bellevue, Nebraska
679
mi
from 43215
Bellevue, NE
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Bethlehem, Pennsylvania
407
mi
from 43215
Bethlehem, PA
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Charlotte, North Carolina
348
mi
from 43215
Charlotte, NC
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Cincinnati, Ohio
98
mi
from 43215
Cincinnati, OH
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Costa Mesa, California
1964
mi
from 43215
Costa Mesa, CA
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Encinitas, California
1949
mi
from 43215
Encinitas, CA
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2055
mi
from 43215
Eugene, OR
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Fall River, Massachusetts
631
mi
from 43215
Fall River, MA
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Huntington Beach, California
1969
mi
from 43215
Huntington Beach, CA
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Medford, Oregon 97504
2058
mi
from 43215
Medford, OR
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Miami Lakes, Florida
983
mi
from 43215
Miami Lakes, FL
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Minneapolis, Minnesota
625
mi
from 43215
Minneapolis, MN
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North Dartmouth, Massachusetts
639
mi
from 43215
North Dartmouth, MA
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Oklahoma City, Oklahoma
849
mi
from 43215
Oklahoma City, OK
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Palmdale, California
1951
mi
from 43215
Palmdale, CA
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Pittsburgh, Pennsylvania
162
mi
from 43215
Pittsburgh, PA
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Portland, Oregon
2026
mi
from 43215
Portland, OR
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Rancho Mirage, California
1884
mi
from 43215
Rancho Mirage, CA
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Riverside, California
1928
mi
from 43215
Riverside, CA
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Rochester, New York
355
mi
from 43215
Rochester, NY
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Rock Hill, South Carolina
365
mi
from 43215
Rock Hill, SC
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Rolling Hills Estates, California
1985
mi
from 43215
Rolling Hills Estates, CA
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San Antonio, Texas
1138
mi
from 43215
San Antonio, TX
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San Diego, California
1951
mi
from 43215
San Diego, CA
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San Jose, California
2088
mi
from 43215
San Jose, CA
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Seattle, Washington 98105
2005
mi
from 43215
Seattle, WA
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Spartanburg, South Carolina
351
mi
from 43215
Spartanburg, SC
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St. Louis, Missouri
394
mi
from 43215
St. Louis, MO
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Tallahassee, Florida
661
mi
from 43215
Tallahassee, FL
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Tampa, Florida
831
mi
from 43215
Tampa, FL
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White Marsh, Maryland
351
mi
from 43215
White Marsh, MD
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