A Glimpse Into the Future
Beclomethasone dipropionate (QVAR®) inhalation aerosol was originally approved by the FDA on September 15, 2000 for maintenance treatment of asthma as prophylactic therapy in adults and adolescents 12 years of age and older. Beclomethasone dipropionate is unique in that it is formulated as a solution rather than a suspension with a particle size of about 1 μm. Its small particle size is better able to penetrate both the large and small airways of the lungs.
In May 2002, approval was extended to children 5 to 11 years of age. On May 23, 2014, the FDA approved the addition of a dose counter to the beclomethasone dipropionate HFA. The recommended starting dose for children 5 to 11 years old is 40 mcg twice daily (max 80 mcg twice daily), regardless of previous asthma control therapy. For patients aged 12 years and older not previously receiving ICS therapy, the starting dose is 40 to 80 mcg twice daily (max 360 mcg twice daily); for patients previously receiving ICS therapy, the starting dose is 40 to 160 mcg twice daily (max 360 mcg twice daily).
QVAR® (beclomethasone dipropionate) breath actuated inhaler (BAI) began phase III clinical trials in the U.S. in December 2013. Similar in design to the Respiclick inhaler, the BAI would eliminate the need for the patient to coordinate pressing a dose-release button while simultaneously inhaling deeply. One study will evaluate the efficacy of beclomethasone dipropionate administered via BAI at a dose of 320 mcg or 640 mcg per day compared with placebo in subjects 12 years of age or older with persistent asthma. The primary endpoint is standardized baseline-adjusted trough morning FEV1 area under the effect curve from time 0 to 6 weeks. The estimated primary completion date is June 2016.
Another study will evaluate the efficacy and safety of beclomethasone dipropionate at a dose of 80 mcg or 160 mcg per day administered via BAI and MDI compared with placebo in pediatric patients age 4 to 11 with persistent asthma. The primary endpoint is change from baseline in percent predicted trough morning FEV1 over the 12 week treatment period. The estimated primary completion date is January 2016. If approved by the FDA, beclomethasone dipropionate BAI will provide yet another therapy for maintenance treatment of asthma that could potentially have a positive impact on compliance and outcomes in children and adolescents with asthma.
The editors would like to thank Dr. W. Gerald Teague for serving as our guest editor this month.
Pediatr Pharm. 2015;21(12) © 2015 University of Virginia