SAN FRANCISCO — Used once daily, a single pressurized metered-dose inhaler containing both budesonide and formoterol provided good asthma control in patients with mild to moderate persistent asthma, according to a series of poster presentations at the International Conference of the American Thoracic Society.
The poster presentations—by Dr. William E. Berger of a group practice specializing in allergy and asthma in Mission Viejo, Calif.; Dr. Eugene R. Bleeker, professor of medicine at Wake Forest University, Winston-Salem, N.C.; and three employees of AstraZeneca Pharmaceuticals L.P.—reported on different aspects of the same five-armed, randomized, controlled trial. This trial compared a once-daily dosage of 320 mcg of budesonide and 9 mcg formoterol, a once-daily dosage of 160 mcg budesonide and 9 mcg formoterol, a twice-daily dosage totaling 320 mcg budesonide and 18 mcg of formoterol, a once-daily dosage of 320 mcg of budesonide alone, and placebo.
The 12-week multicenter trial involved 751 patients, aged 16 years and older. Patients were excluded from the trial if they had severe persistent asthma, had received systemic corticosteroids within 1 month of screening, were current smokers, or had a smoking history greater than 10 pack-years.
The studies were supported by AstraZeneca, which manufactures budesonide and formoterol under the brand name Symbicort.
All the active treatments were significantly more effective than placebo in all measures of lung function, including evening peak expiratory flow (PEF), morning PEF, and morning and evening forced expiratory volume in 1 second (FEV1).
Both of the once-daily doses of budesonide and formoterol were more effective on these measures than was budesonide alone, even when the combination drug contained only 160 mcg of budesonide.
Twice-daily dosing with budesonide and formoterol was significantly more effective on evening measures of lung function than were the once-daily doses.
Investigators assessed asthma control with an electronic diary provided to all patients. Patients recorded daytime and nighttime asthma symptoms, nighttime awakenings because of asthma, and the use of rescue medication.
For all measures of asthma control, the 320/18 twice-daily dosage of budesonide and formoterol and the 320/9 once-daily dosage were significantly more effective than was either placebo or budesonide alone. The 320/9 once-daily dosage provided about the same amount of nighttime asthma control as did the 320/18 twice-daily dosage, despite having only half the total daily dose of formoterol. On the other hand, twice-daily dosing was more effective than once-daily dosing on daytime asthma control.