By Maggie Schwarz
WASHINGTON, DC -- March 17, 2009 -- Small-airway function improves when a long-acting beta agonist is added to an inhaled corticosteroid for management of mild to moderate asthma in children and adolescents, researchers reported here at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.
Steven M. Meltzer, MD, Allergy & Asthma Center of Southern California, Long Beach, California, and colleagues assessed the effect on small-airway function of budesonide plus formoterol (BUD/FM) 160/18 mcg administered together by pressurised metered-dose inhaler (pMDI) twice daily in patients aged 6 to 15 years who had persistent asthma previously stabilised with this regimen.
Results of the study were presented on March 15.
Twice-daily dosing with the combination of these agents administered by a pMDI has shown greater efficacy than monotherapy with BUD once daily in patients aged 6 to 15 years who had persistent asthma previously stabilised by BUD/FM pMDI BID. The effect of BUD/FM pMDI on small-airway function, however, has not been studied in this patient population.
Dr. Meltzer and colleagues assessed the effect on small airway function after 12 hours and 24 hours. Forced expiratory flow during the middle half of exhalation (FEF25%-75%) was used to compare twice-daily and once-daily dosing of BUD/FM pMDI.
After a run-in period, patients with stable asthma were randomised to BUD/FM pMDI 40/4.5 mcg at 2 inhalations BID, BUD/FM pMDI 80/4.5 mcg at 2 inhalations once daily in the evening, or BUD pMDI 80 mcg at 2 inhalations once daily in the evening. Albuterol was provided as needed.
In children, changes in evening FEF25%-75% were 3.6%, -3.1%, and -3.3% for BUD/FM twice daily, BUD/FM once daily, and BUD once daily, respectively. Changes in morning FEF25%-75% were -4.4%, 1.9%, and -14.3%, respectively.
In adolescents, changes in evening FEF25%-75% were 3.1%, -0.1%, and -7.7%, respectively. Changes in morning FEF25%-75% were -0.4%, 2.1%, and -11.9%, respectively.
Dr. Meltzer said that predose FEF25%-75% was maintained in patients receiving BUD/FM twice daily. At the end of the once-daily interval (evening), FEF25%-75% was decreased in those receiving once-daily BUD/FM and BUD versus BUD/FM twice daily.
At 12 hours (morning), however, changes in FEF25%-75% were smaller in the once-daily BUD/FM group versus the once-daily BUD group.
The results demonstrate the benefit of adding a long-acting beta agonist to an inhaled corticosteroid in patients with asthma, the researchers concluded.
Funding for this study was provided by AstraZeneca.
[Presentation title: Effect of Once-Daily (qd) Budesonide/Formoterol Pressurized Metered-Dose Inhaler (BUD/FM pMDI) on Forced Expiratory Flow Between 25% and 75% (FEF25-75%) in Children and Adolescents (Aged 6-11 and 12-15 Years) With Asthma Previously Stable on Twice-Daily (bid) BUD/FM pMDI. Abstract 290]
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