The study will measure the change in lung function in subjects with asthma after inhaling
from either of two inhalers: Albuterol Spiromax® or placebo.
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- Written informed consent/assent
- General good health
- Persistent asthma, with an FEV1 50-80% predicted.
- Ability to perform spirometry in an acceptable manner as per protocol guidelines.
- Ability to perform PEFR with a handheld peak flow meter.
- Demonstration of reversible bronchoconstriction as verified by a 15% or greater
increase from baseline FEV1.
- Taking inhaled corticosteroids at a stable dose for at least 4 weeks prior to the
Screening Visit.
- Non-smokers.
- Capable of understanding the requirements, risks, and benefits of study
participation.
- Other inclusion criteria apply.
Exclusion Criteria:
- Participation in any investigational drug trial within the 30 days preceding the
Screening Visit (SV).
- A known hypersensitivity to albuterol or any of the excipients in the formulations.
- History of severe milk protein allergy.
- History of a respiratory infection or disorder that has not resolved within the 2
weeks preceding the Screening Visit (SV).
- Currently requires treatment with β2-adrenergic receptor antagonists or non-selective
β-receptor blocking agents.
- 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
Screening Visit (SV). A subject must not have had any hospitalization for asthma
within 6 months prior to the Screening Visit (SV).
- Historical or current evidence of any clinically significant non-asthmatic acute or
chronic condition including.
- Other exclusion criteria apply.
Teva Investigational Site 10077, Birmingham, Alabama, United States
Teva Investigational Site 10079, Phoenix, Arizona, United States
Teva Investigational Site 10569, Costa Mesa, California, United States
Teva Investigational Site 10053, Fountain Valley, California, United States
Teva Investigational Site 10065, Huntington Beach, California, United States
Teva Investigational Site 10572, Huntington Beach, California, United States
Teva Investigational Site 10075, Los Angeles, California, United States
Teva Investigational Site 10061, Roseville, California, United States
Teva Investigational Site 10066, San Diego, California, United States
Teva Investigational Site 10068, Denver, Colorado, United States
Teva Investigational Site 10069, Denver, Colorado, United States
Teva Investigational Site 10058, Miami, Florida, United States
Teva Investigational Site 10060, Miami, Florida, United States
Teva Investigational Site 10064, Ormond Beach, Florida, United States
Teva Investigational Site 10071, Savannah, Georgia, United States
Teva Investigational Site 10073, Wichita, Kansas, United States
Teva Investigational Site 10070, Owensboro, Kentucky, United States
Teva Investigational Site 10063, Bethesda, Maryland, United States
Teva Investigational Site 10571, Gaithersburg, Maryland, United States
Teva Investigational Site 10067, Wheaton, Maryland, United States
Teva Investigational Site 10072, St. Louis, Missouri, United States
Teva Investigational Site 10050, Missoula, Montana, United States
Teva Investigational Site 10057, Raleigh, North Carolina, United States
Teva Investigational Site 10051, Cincinnati, Ohio, United States
Teva Investigational Site 10078, Sylvania, Ohio, United States
Teva Investigational Site 10054, Oklahoma City, Oklahoma, United States
Teva Investigational Site 10568, Oklahoma City, Oklahoma, United States
Teva Investigational Site 10055, Tulsa, Oklahoma, United States
Teva Investigational Site 10056, Medford, Oregon, United States
Teva Investigational Site 10076, Medford, Oregon, United States
Teva Investigational Site 10684, Charleston, South Carolina, United States
Teva Investigational Site 10570, Spartanburg, South Carolina, United States
Teva Investigational Site 10049, Live Oak, Texas, United States
Teva Investigational Site 10052, San Antonio, Texas, United States
Teva Investigational Site 10685, Waco, Texas, United States
Teva Investigational Site 10059, Fairfax, Virginia, United States
Teva Investigational Site 10074, Puyallup, Washington, United States
Teva Investigational Site 10062, Tacoma, Washington, United States