The four trials also assessed efficacy of the ICS/LABA products. The primary efficacy endpoint was asthma exacerbation, defined as a deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days, or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. The results showed that the ICS/LABA combination reduced asthma exacerbations compared to ICS alone, noting that the majority of these exacerbations were those that required at least 3 days of systemic corticosteroids. This efficacy information has been added to the Clinical Studies section of the ICS/LABA drug labels.
Quick-Relief for All Patients
Bronchodilator as needed for symptoms: Short-acting inhaled ß2-agonist by nebulizer ( mg/kg in 2-3 cc of saline) or inhaler with face mask and spacer (2-6 puffs; for exacerbations, repeat every 20 minutes for up to 1 hour).
With Viral Respiratory Infection
The Expert Panel recommends the following actions for managing exacerbations due to viral respiratory infections, which are especially common in children. These exacerbations may be intermittent yet severe.