ORIGINAL ARTICLES
One-year efficacy and safety of inhaled formoterol dry powder in children with persistent asthma

https://doi.org/10.1016/S1081-1206(10)61935-7Get rights and content

Background

The long-term efficacy and safety of formoterol dry powder capsules for inhalation in pediatric asthma have not previously been evaluated.

Objective

We examined the effectiveness of inhaled formoterol over a period of 12 months in asthmatic children who were still symptomatic despite anti-inflammatory treatment.

Methods

After a run-in period, 518 patients (5 to 12 years old) were randomized in a double-blind manner to receive 12 or 24 μg formoterol dry powder (Foradil, Novartis Pharma AG, Basel, Switzerland) or placebo twice daily for 12 months. The drug was administered by inhaler (Aerolizer, Novartis Pharma AG) and was given in addition to their anti-inflammatory treatment. The primary variable was the area under the curve for forced expiratory volume in 1 second measured over 12 hours after the morning dose of study medication.

Results

The area under the curve for forced expiratory volume in 1 second after the first dose of treatment and after 3 and 12 months of treatment was significantly greater for patients receiving formoterol 12 μg and 24 μg than for patients receiving placebo (all P ≤ 0.0062). Compared with placebo, both doses of formoterol significantly improved morning and evening premedication peak expiratory flow rate (all P < 0.001). In the group treated with formoterol 24 μg, median symptom score and median dose of rescue medication at night were lower than during the run-in period, whereas the opposite occurred in the placebo group. The incidence of hospitalizations for asthma was higher in the formoterol groups than in the placebo group.

Conclusion

Our results indicate that, in asthmatic children who are still symptomatic despite anti-inflammatory therapy, the addition of formoterol consistently improves airflow obstruction and nocturnal symptoms and reduces the use of rescue medication. However, this treatment requires close disease monitoring to detect early signs of acute exacerbation.

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    This study was sponsored by Novartis. The investigators have received payments for study conduction but have not made any financial arrangement whereby the value of the compensation could be influenced by the outcome of the study. They do not have a proprietary interest in the test product and do not hold a significant equity interest in the sponsor. MH Thomson, MD Till, and G Della Cioppa hold permanent positions with Novartis Pharmaceuticals.

    J Castellsague has moved to Pharmacia, Spain.

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