One daily inhalation of ARNUITY ELLIPTA 50 mcg demonstrated a greater improvement from baseline in percentage of 24-hour periods without the need for beta2
-agonist rescue medications compared with placebo averaged over 12 weeks of treatment in patients aged 5-11 years.
These results are descriptive only.
- 12-week multicenter, randomized, double-blind, double-dummy, parallel-group, placebo- and active-controlled trial
- Patients aged 5-11 years were randomized to ARNUITY ELLIPTA 50 (n=120), ARNUITY ELLIPTA 100 (n=118), fluticasone furoate 25 mcg (n=118), active control (n=118), or placebo (n=119)
- 593 children aged 5-11 years with inadequately controlled asthma
- Mean baseline prebronchodilator PEF 189.5 L/min
- Mean change from baseline in daily predose AM PEF averaged over the 12-week treatment period
- Change from baseline in percentage of rescue-free days averaged over 12 weeks of treatment. Endpoint not multiplicity adjusted; therefore, results are descriptive only
The safety data for pediatric patients is based on one 12-week clinical trial that enrolled 593 subjects with asthma aged 5-11 years. ARNUITY ELLIPTA 50 mcg was studied in 120 subjects (46 females and 74 males).
Adverse reactions (≥3% and greater than placebo) seen in pediatric subjects were similar to those reported in adult and adolescent subjects.
|Adverse Reaction||ARNUITY ELLIPTA|
n = 120
n = 119