Pharmacokinetic and Pharmacodynamic Profiles of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients With Asthma

This is a single center, open-label, 2-period crossover study. The study consists of a
screening visit followed by a treatment period comprising 2 treatment visits. The treatment
period visits will be separated by a 4 to 14-day washout period. Eligible patients will be
kept overnight prior to each treatment period.

Inclusion Criteria:

1. Written informed consent/assent signed and dated by the patient and/or
parent/caregiver/legal guardian (as appropriate) before conducting any study-related
procedure.

2. Male or pre-menarchal female patient 4-11 years of age, inclusive, as of the
Screening Visit (SV)

3. Has a documented physician diagnosis of persistent asthma of a minimum of 3 months
duration that has been stable for at least 4 weeks prior to the SV. The asthma
diagnosis must be in accordance with the National Asthma Education and Prevention
Program Guidelines Expert Panel Report 3 (EPR3).

4. Forced expiratory volume in 1 second (FEV1) >80% predicted for age, height and gender
and race at the SV based on the pediatric population standards.

5. Any patient being treated with inhaled corticosteroids (ICS) must be on a lowdose
regimen (200 mcg or less of fluticasone propionate per day or equivalent), which has
been stable for at least 4 weeks prior to the SV and which is expected to be
maintained for the duration of the study

6. Has required less than 4 inhalations per week of a rescue bronchodilator (on average)
for the 4 weeks preceding the SV

7. Has the ability to withhold inhaled albuterol for at least 72 hours preceding each
Treatment Visit (TV).

- Other criteria apply, including must weigh at least 45 pounds

Exclusion Criteria:

1. A known hypersensitivity to albuterol or any of the excipients in the inhaler
formulations (lactose, ethanol, etc.)

2. Participation (receiving study drug) in any investigational drug trial within the 30
days preceding the SV or planned participation in another investigational drug trial
at any time during this trial

3. History of severe milk protein allergy

4. Proneness to orthostatic dysregulation, syncope, or blackouts

5. History of a respiratory infection or disorder (including, but not limited to
bronchitis, pneumonia, acute or chronic sinusitis, otitis media, influenza) that has
not resolved within 2 weeks preceding the SV.

6. History of life-threatening asthma or that is defined for this protocol as an asthma
episode that required intubation and/or was associated with hypercapnea, respiratory
arrest or hypoxic seizures

7. Any asthma exacerbation requiring systemic corticosteroids within 3 months of the SV.
A patient must not have had any hospitalization for asthma within 6 months prior to
the SV.

- Other criteria apply.