Safety Study of Albuterol Spiromax® in Subjects With Asthma

Inclusion Criteria:

- Written informed consent and HIPAA signed and dated by the subject or written
informed assent signed and dated both by the subject and/or parent/caregiver/legal
guardian before conducting any study related procedure.

- Males or females with asthma ages 12 years or older at screening.

- Documented history of persistent asthma and current use of an MDI containing any
short-acting beta-adrenergic agonist (e.g. albuterol, levalbuterol,) on average of at
least once/week over the 4-weeks prior to screening. The asthma diagnosis must be
consistent with the diagnosis of asthma as per the National Asthma Education and
Prevention Program.

- If female, is currently not pregnant, breast feeding, or attempting to become
pregnant (for 4 weeks before the screening visit and throughout the duration of the
study), and is of Non-childbearing potential, defined as:

- ≥1 year post-menopausal or

- Surgically sterile (tubal ligation, bilateral oophorectomy, salpingectomy, or
hysterectomy) or is of

- Childbearing potential, has a negative serum pregnancy test, and is willing to
commit to using a consistent and acceptable method of birth control

- General good health in the opinion of the investigator as indicated by medical
history, physical examination, laboratory tests (hematology, serum chemistry and
urinalysis) assessed as either normal or abnormal not clinically significant (NCS)
per the principal investigator, as well as a 12-lead ECG interpreted as either
"Normal" or "Abnormal NCS" as determined by the central cardiologist. Subjects must
also be free of any clinically significant, uncontrolled concomitant conditions other
than asthma that could interfere with study conduct, influence the interpretation of
study observations/results, or put the subject at increased risk during the trial.

- Capable of understanding the requirements, risks, and benefits of study
participation, and, as judged by the investigator, and being compliant with all study
requirements (visits, record-keeping, etc).

- Non-smoker for at least one year prior to the screening visit and a maximum pack-year
(PY) smoking history of 10 years.

- Able to demonstrate proper inhaler technique with study inhaler.

Exclusion Criteria:

- Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for
in vitro fertilization during the study period or for 30 days following the subject's
last study related visit.

- Participation in any investigational drug trial within 30 days preceding the
screening visit or planned participation in another investigational drug trial at any
time during this trial.

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

- History of severe milk protein allergy

- History of an upper or lower respiratory tract infection or disorder (including, but
not limited to bronchitis, pneumonia, acute or chronic sinusitis, otitis media,
influenza, etc) which is not resolved at least 1 week prior to the SV.

- History of alcohol or drug abuse within two years preceding the SV.

- Use of any protocol prohibited concomitant medications for asthma (any oral
β2-adrenergic agonists) or any protocol prohibited concomitant non-asthma medications
including treatment with β2-adrenergic receptor antagonists and non-selective
β-receptor blocking agents such as β-blocking anti-hypertensive products
(administered by any route), MAO inhibitors, and/or tricyclic antidepressants.
(Subject's own MDI short-acting β-agonist rescue inhaler should be used until the
start of the Run-In period when a study rescue inhaler is provided.)

- Inability or unwillingness to comply with the protocol requirements.

- History of life-threatening asthma [defined here as an asthma episode requiring
intubation and/or associated with hypercapnea, respiratory arrest or hypoxic
seizures.]

- Any asthma exacerbation within 3 months of the SV requiring oral or systemic
corticosteroids or any hospitalization for asthma within 6 months of the SV.

Note: An exacerbation of asthma is defined as any worsening of asthma requiring any
treatment other than rescue albuterol or the subject's regular asthma maintenance therapy.
This includes requiring the use of systemic corticosteroids and/or emergency room visit or
hospitalization or a change in subject's regular asthma maintenance treatment. A subject
does not need to be withdrawn from the study due to an asthma exacerbation unless
hospitalization is required or unless the principal investigator believes it is in the
subjects' best interest to withdraw from the study.

- Previous participation in an inhaled Albuterol Spiromax® (Teva) study, with the
exception of the ABS-AS-306 study.

- Study participation by clinical investigator site employees and/or their immediate
relatives.

- Study participation by related or non-related individuals living in the same
household, i.e. only one subject per household may participate in the study.

- Any clinically significant endocrine, hematological, hepatic, renal,
gastrointestinal, neurological, cardiac, metabolic, immunological, any non-asthmatic
acute or chronic pulmonary condition (including but not limited to bronchitis,
emphysema, active tuberculosis, bronchiectasis, cystic fibrosis), and malignancy
other than basal cell carcinoma. Significant is defined for this protocol as any
condition that, in the opinion of the investigator, would put the safety of the
subject at risk through participation, or which could affect the safety analyses.

- Any medical or psychological condition that in the investigator's opinion should
preclude enrollment.