Chronic-Dose Safety and Efficacy Study of an Albuterol Metered Dose Inhaler (MDI) Inhaler Using a Hydrofluoroalkane (HFA) Propellant In Pediatric Asthmatics

• Maximum Percent Change From Baseline [ Time Frame: 2 hours following completion of dosing on Day 22 ] [ Designated as safety issue: No ]
  The FEV1 test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the amount of air blown over time. The maximum percent change from baseline in the Forced Expiratory Volume in one second (FEV1) observed up to 2 hours following completion of dosing using Day 22 baseline.
• Maximum Percent Change in Peak Expiratory Flow (PEF) [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the amount of air blown over time. Maximum percent change in Peak Expiratory Flow (PEF) observed up to 2 hours following completion of dosing using Day 22 baseline.

• Baseline Adjusted Area-under-the-effect-curve for Percent of Predicted FEV1 Over 6 Hours Post Dose [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  Baseline
• Baseline-adjusted area-under-the Effect Curve for Percent of Predicted FEV1 Over 6 Hours Post-dose on Day 22. [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
• Baseline-adjusted area-under-the Effect Curve for PEF Over 6 Hours Post-dose. [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
• The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in FEVl of at Least 15% is Noted in Participants Who Responded to the Medication. [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
• The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in PEF of at Least 15% is Noted [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
• The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in FEVl of at Least 12% is Noted [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
• The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in PEF of at Least 12% is Noted [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
• The Time (in Minutes) to Maximum FEVl [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
• The Time (in Minutes) to Maximum PEF [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
• The Duration of Effect (in Hours) as Measured From the Time of Dosing to the Time at Which the FEVl First Decreases Below 15% [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
• The Duration of Effect (in Hours) as Measured From the Time of Dosing the Time at Which the FEVl First Decreases Below 12% [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
• The Duration of Effect (in Hours) as Measured From the Time of Dosing the Time at Which the PEF First Decreases Below 15% [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
• The Duration of Effect (in Hours) as Measured From the Time of Dosing the Time at Which the PEF First Decreases Below 12% [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
• Highest Daily Asthma Symptom Scores by Study Week [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
  Highest daily asthma symptom scores by study week. For this assessment, patients self-evaluate and record on the diary card the following asthma symptoms experienced during the day (i.e. last 12-14 hours): wheeze, shortness of breath, cough, tightness of chest. The worst of these symptoms will be scored daily as 0 = No symptoms occurred, 1 = Symptom occurred but did not interfere with daily activity, 2 = Symptom occurred but was sometimes annoying or interfered with daily activity, 3 = Symptom present even at rest and was annoying or interfered with daily activity
• The Number of Asthma-related Nocturnal Awakenings Per Week Requiring the Use of Rescue Medication [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
• The Daily a.m. Pre-dose PEF [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
• The Average Number of Puffs of Rescue Medication Per 24 Hour Period [ Time Frame: Week 3 ] [ Designated as safety issue: No ]

The primary objective of this study is to evaluate the chronic-dose and efficacy of Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.

Eligible patients will be randomized to receive one of the following two treatments four times a day for 21 days:

Placebo in a metered-dose inhaler using a hydrofluoroalkane propellant (Placebo-HFA-MDI).

180 mcg of Albuterol in a metered-dose inhaler using a hydrofluoroalkane propellant (Albuterol-HFA-MDI)

• Drug: Albuterol
  Albuterol HFA MDI 180 mcg
• Drug: Placebo
  Placebo HFA MDI

• Experimental: 180 mcg of Albuterol
  Dosing with 180 mcg of albuterol in a metered-dose inhaler (MDI) utilizing a hydrofluoroalkane (HFA) propellant. (Hereafter noted as "Albuterol HFA-MDI.")
  Intervention: Drug: Albuterol
• Placebo Comparator: Placebo
  A placebo of a metered-dose inhaler (MDI) utilizing a hydrofluoroalkane (HFA) propellant. (Hereafter noted as "Placebo-HFA-MDI.")
  Intervention: Drug: Placebo

Inclusion Criteria:

• Male and female child aged 4-11 years, inclusive Asthma of a minimum of six months duration that has been stable for at least four weeks prior to screening.

Exclusion Criteria:

• Hospitalization for acute asthma exacerbation greater than two years in 12 months prior to screening and/or received ER treatment or hospitalization for asthma exacerbation.