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New Astra Zeneca medication for treatment of persistent asthma in children
Food and Drug Administration is approving AstraZeneca’s new supplemental drug application for the pediatric needs. SYMBICORT now will be used for treatment of persistent asthma in children.
Kathy Lampl MD, Director, told in her latest interview that children suffering from asthma that is not adequately controlled by ICS therapy may experience unpleasant asthma symptoms during their sleep.
We have developed new recommendations for treatment of children who have moderate to severe persistent asthma: optimal is combination therapy with inhaled ICS and LABA. This remains true for children who are not controlled with ICS therapy alone, according to the NIH Guidelines.
The safety profile and efficacy of SYMBICORT was tested during a 12-week study. The study was as it should be: double-blind, randomized, active-controlled study. During this research 411 children aged from 6 to 15 years previously treated with ICS therapy took part. All of them had mild to moderate persistent asthma symptoms.
All of the patients stopped their previous treatment and were divided (randomized) by groups:
- One group received two inhalations twice-daily of budesonide pMDI 40 micrograms
- Second group received treatment with SYMBICORT pMDI 40/4.5 mcg two inhalations two times a day
- Third group receives budesonide pMDI 40 mcg two inhalations twice-daily
- Fourth group received treatment with formoterol DPI 4.5 mcg two inhalations twice-daily.
Results have shown significantly greater improvements from baseline and SYMBICORT. SYMBICORT also demonstrated significantly greater improvements, compared with budesonide.
Results also showed that SYMBICORT was well tolerated for 12 weeks with a safety profile similar to its mono-components, budesonide and formoterol.
