The primary objective of this study is to evaluate the efficacy of Albuterol Spiromax®
versus placebo in subjects with persistent asthma.
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- Written informed consent/assent
- At least 12 years of age at screening
- General good health
- Persistent asthma for ≥3 months, with an FEV1 50-80% predicted and ≥15% reversibility
- Taking inhaled corticosteroids at a stable dose (≤ equivalent of 500mcg of
fluticasone propionate/day) for at least 4 weeks prior to the Screening Visit.
- 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.
Teva Investigational Site 10225, Costa Mesa, California, United States
Teva Investigational Site 10250, Encinitas, California, United States
Teva Investigational Site 10230, Huntington Beach, California, United States
Teva Investigational Site 10255, Palmdale, California, United States
Teva Investigational Site 10231, Rancho Mirage, California, United States
Teva Investigational Site 10252, Riverside, California, United States
Teva Investigational Site 10242, Rolling Hills Estates, California, United States
Teva Investigational Site 10238, San Diego, California, United States
Teva Investigational Site 10243, San Jose, California, United States
Teva Investigational Site 10247, Miami Lakes, Florida, United States
Teva Investigational Site 10239, Tallahassee, Florida, United States
Teva Investigational Site 10234, Tampa, Florida, United States
Teva Investigational Site 10253, Bangor, Maine, United States
Teva Investigational Site 10257, Baltimore, Maryland, United States
Teva Investigational Site 10254, White Marsh, Maryland, United States
Teva Investigational Site 10235, Fall River, Massachusetts, United States
Teva Investigational Site 10236, North Dartmouth, Massachusetts, United States
Teva Investigational Site 10226, Minneapolis, Minnesota, United States
Teva Investigational Site 10233, Minneapolis, Minnesota, United States
Teva Investigational Site 10241, St. Louis, Missouri, United States
Teva Investigational Site 10229, Bellevue, Nebraska, United States
Teva Investigational Site 10227, Rochester, New York, United States
Teva Investigational Site 10244, Charlotte, North Carolina, United States
Teva Investigational Site 10248, Cincinnati, Ohio, United States
Teva Investigational Site 10249, Oklahoma City, Oklahoma, United States
Teva Investigational Site 10232, Eugene, Oregon, United States
Teva Investigational Site 10259, Medford, Oregon, United States
Teva Investigational Site 10237, Portland, Oregon, United States
Teva Investigational Site 10240, Bethlehem, Pennsylvania, United States
Teva Investigational Site 10246, Pittsburgh, Pennsylvania, United States
Teva Investigational Site 10256, Pittsburgh, Pennsylvania, United States
Teva Investigational Site 10251, Rock Hill, South Carolina, United States
Teva Investigational Site 10228, Spartanburg, South Carolina, United States
Teva Investigational Site 10258, San Antonio, Texas, United States
Teva Investigational Site 10245, Seattle, Washington, United States