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Budesonide/Formoterol by Metered-Dose Inhaler Appears Safe in Children With Asthma: Presented at ATS

By Marvin Ross

TORONTO -- May 26, 2008 -- Budesonide/formoterol pressurised metered-dose inhaler (MDI) is well tolerated as a treatment for children with persistent, mild to moderate asthma, and its safety profile is similar to that of budesonide and formoterol, according to a 12-week, randomised trial.

The study was presented here on May 20 at the 104th International Conference of the American Thoracic Society (ATS).

David S. Pearlman, MD, Clinical Researcher, Colorado Allergy and Asthma Centers, Denver, Colorado, and colleagues enrolled 411 children aged 6 to 15 years with asthma.

Patients participated in a 2-week run-in phase during which their asthma medications (inhaled corticosteroids) were discontinued and they were given 2 inhalations of budesonide 40 mcg BID by pressured MDI.

Researchers then randomised 128 children to receive budesonide/formoterol 40/4.5 mcg 2 inhalations BID, 145 children to receive budesonide 40 mcg 2 inhalations BID, and 138 children to receive formoterol 4.5 mcg 2 inhalations BID.

Patients were evaluated for adverse events, clinical chemistry, and vital signs and underwent electrocardiograms. Adverse events were recorded by the caregivers in paper diaries and were reviewed by the investigators. Asthma symptoms or signs were considered adverse events if they were new to the patient, were serious, were not consistent with the patient's pre-existing asthma history, or led to discontinuation.

All treatments were well tolerated; most adverse events were of mild or moderate intensity. Adverse events were reported by 70.3% of the budesonide/formoterol group, 63.4% of the budesonide group, and 70.3% of the formoterol patients.

Drug-related adverse events were reported by 3.1% of budesonide/formoterol patients, 3.4% of budesonide patients, and 6.5% of formoterol patients. These events included asthma, headache, insomnia, cough, and psychomotor hyperactivity.

Mean changes in serum glucose levels and serum potassium levels from baseline to treatment maximum in the budesonide/formoterol patients compared with budesonide were statistically significant (P < .05 and P < .01, respectively). The researchers stated that both these changes were small and were not considered to be clinically meaningful.

Mean changes in heart rate from baseline were small and not clinically meaningful, according to the researchers. The percentages of patients with heart rate values that were normal at baseline and then crossed the high threshold (>=100 BPM) at treatment maximum were higher for the budesonide/formoterol (11.7%) and formoterol (8.7%) groups compared with the budesonide group (3.4%).

No clinically meaningful differences were observed among groups for vital signs and/or physical examinations.

Budesonide/formoterol pressured MDI was well tolerated in this group of patients and had a safety profile similar to that of budesonide or formoterol alone, the researchers concluded.


[Presentation title: Safety of Budesonide/Formoterol Pressurized Metered-Dose Inhaler (Budesonide/Formoterol pMDI) in Children With Asthma Previously Treated With Inhaled Corticosteroids (ICSs). Poster K67]

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