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Budesonide/Formoterol Pressured Metered Dose Better Than Either Agent Alone in Children With Asthma: Presented at ATS

By Marvin Ross

TORONTO -- May 23, 2008 -- Budesonide/formoterol by pressurised metered dose inhaler showed greater efficacy in children with mild to moderate persistent asthma who had previously been treated with inhaled corticosteroids than did either drug alone, according to a 12-week, randomised, double-blind, double-dummy, active-control study conducted in 52 centres in the United States.

The results were presented here at the 104th International Conference of the American Thoracic Society (ATS) by Dr. Kevin R. Murphy, MD, Pediatric Allergist and Immunologist, Midwest Children's Chest Physicians, Omaha, Nebraska, in a poster session on May 20.

Children in the study were aged 6 to 15 years, had mild to moderate persistent asthma for at least 6 months, and had been using low- to medium-dose inhaled corticosteroids alone or in combination with other nonsteroidal asthma medications for at least 4 weeks before screening.

Exclusion criteria were hospitalisation or emergency treatment more than once in the 6 months prior to enrolment, treatment with systemic corticosteroids within 4 weeks of screening, and known hypersensitivity to beta2-adrenergic agonists, budesonide, formoterol, or inhaled lactose.

Albuterol provided by pressurised metered-dose inhaler as rescue medication was permitted during the study but was to be withheld within 6 hours before scheduled spirometry. Use of nasal corticosteroids, nasal cromolyn sodium, or immunotherapy was permitted.

Not permitted during the trial were asthma medications (other than budesonide or formoterol), nebulised albuterol, systemic or topical corticosteroids, hydroxyzine, beta-blockers, or hydrocortisone at a concentration >1%.

Subjects discontinued their previous asthma therapy for a 2 week run-in period and used budesonide 40 mcg in 2 inhalations BID and rescue albuterol as needed. Symptomatic patients were then stratified by age (<8 and >=8 years) and were randomised to budesonide/formoterol 40 mcg/4.5 mcg in 2 inhalations BID, budesonide 40 mcg in 2 inhalations BID, or formoterol 4.5 mcg in 2 inhalations BID.

Clinic visits occurred at 2, 6, and 12 weeks after randomisation, and patients were instructed to withhold study medications on the day of clinic visits.

There were 128 subjects in the budesonide/formoterol arm, 145 in the budesonide alone arm, and 138 in the formoterol-alone arm.

Budesonide/formoterol resulted in significantly greater improvements in predose morning and afternoon peak expiratory force (PEF).

Improvements from baseline to the average over the treatment period in morning and evening PEF was significantly greater for budesonide/formoterol (23.6 and 19.6 L/min, respectively) versus budesonide (8.0 and 6.4 L/min, respectively) and formoterol (8.6 and 6.9 L/min, respectively; P < .001).

Significant improvements from baseline in morning and evening PEF were observed within 1 day of the first dose of budesonide/formoterol compared with budesonide and within 2 days of the first dose of budesonide/formoterol compared with formoterol (P < .05).

Improvements in morning and evening PEF observed in the budesonide/formoterol group were maintained for the full 12 weeks of the study.

The authors concluded that twice daily treatment with budesonide/formoterol resulted in significantly greater improvements in asthma than either budesonide alone or formoterol alone in children aged 6 to 15 years.


[Presentation title: Efficacy of Budesonide/Formoterol Pressurized Metered-Dose Inhaler (BUD/FM pMDI) in Children With Asthma Previously Treated With Inhaled Corticosteroids (ICSs). Poster K66]

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