The safety and effectiveness of albuterol sulfate HFA for treatment or prevention of bronchospasm and for prevention of exercised-induced bronchospasm in pediatric patients aged 4 years and older have been established. Use of albuterol sulfate HFA for this indication is supported by evidence from adequate and well-controlled studies of two 12-week clinical trials in subjects aged 12 years and older with asthma and one 2-week clinical trial in subjects aged 4 to 11 years with asthma [see Adverse Reactions (6.1), Clinical Studies (14.1)]. 

The safety and effectiveness of albuterol sulfate HFA in pediatric patients younger than 4 years have not been established. Three trials have been conducted to evaluate the safety and efficacy of albuterol sulfate HFA in subjects younger than 4 years and the findings are described below.

Two 4-week randomized, double-blind, placebo-controlled trials were conducted in 163 pediatric subjects aged from birth to 48 months with symptoms of bronchospasm associated with obstructive airway disease (presenting symptoms included: wheeze, cough, dyspnea, or chest tightness). Albuterol sulfate HFA or placebo HFA was delivered with either an AeroChamber Plus Valved Holding Chamber or an Optichamber Valved Holding Chamber with mask 3 times daily. In one trial, albuterol sulfate HFA 90 mcg (n = 26), albuterol sulfate HFA 180 mcg (n = 25), and placebo HFA (n = 26) were administered to children aged between 24 and 48 months. In the second trial, albuterol sulfate HFA 90 mcg (n = 29), albuterol sulfate HFA 180 mcg (n = 29), and placebo HFA (n = 28) were administered to children aged between birth and 24 months. Over the 4-week treatment period, there were no treatment differences in asthma symptom scores between the groups receiving albuterol sulfate HFA 90 mcg, albuterol sulfate HFA 180 mcg, and placebo in either trial.

In a third trial, albuterol sulfate HFA was evaluated in 87 pediatric subjects younger than 24 months for the treatment of acute wheezing. Albuterol sulfate HFA was delivered with an AeroChamber Plus Valved Holding Chamber in this trial. There were no significant differences in asthma symptom scores and mean change from baseline in an asthma symptom score between albuterol sulfate HFA 180 mcg and albuterol sulfate HFA 360 mcg.

In vitro dose characterization studies were performed to evaluate the delivery of albuterol sulfate HFA via holding chambers with attached masks. The studies were conducted with 2 different holding chambers with masks (small and medium size). The in vitro study data when simulating patient breathing suggest that the dose of albuterol sulfate HFA presented for inhalation via a valved holding chamber with mask will be comparable to the dose delivered in adults without a spacer and mask per kilogram of body weight (Table 2). However, clinical trials in children younger than 4 years described above suggest that either the optimal dose of albuterol sulfate HFA has not been defined in this age group or albuterol sulfate HFA is not effective in this age group. The safety and effectiveness of albuterol sulfate HFA administered with or without a spacer device in children younger than 4 years have not been demonstrated.