Background: Since the long-acting beta(2)-agonist bronchodilator, formoterol, first became available for the treatment of subjects with asthma or chronic obstructive pulmonary disease (COPD), generic forms of this agent have been launched in a variety of devices. It is timely to review the characteristics of the original dry powder delivery device, the single-dose Aerolizer*, its in vitro performance and its comparability with other inhaler devices that are now available for delivery of formoterol.Scope: This review focuses on the performance of the formoterol Aerolizer inhaler in comparison with other inhalers. PubliGally available data (PubMed) on the device performance characteristics of the Aerolizer were reviewed and summarized, together with the results of comparative studies performed by the authors. Published studies (PubMed) on patient handling and inhaler technique that include the Aerolizer are described and studies comparing the clinical effect of formoterol in the Aerolizer with formoterol delivered via other devices were reviewed and are summarized.Findings: The Aerolizer performs consistently in dosing efficiency across a range of inspiratory flow rates, suggesting its suitability for use by patients with differing inspiratory flow abilities. The single-dose, capsule-based nature of the device provides patients with obvious feedback on whether the drug has been taken successfully and the Aerolizer has been shown to be one of the more easily used devices in comparative patient handling studies. Studies comparing the clinical effect of formoterol delivered by different inhalation devices show that formoterol via Aerolizer has an equivalent therapeutic effect.Conclusion: Judged on the basis of dosing efficiency, ease of use and clinical equivalence, formoterol Aerolizer remains a useful option in the management of patients with asthma or COPD.

Background: Exercise-induced bronchoconstriction (EIB) is common, particularly in children.Objectives: To compare the protective effect of single doses of formoterol fumarate via Aerolizer with placebo and albuterol in children with EIB.Methods: In this randomized, double-blind, double-dummy, crossover trial, 23 children (aged 4-11 years) received formoterol, 12 or 24 mu g; albuterol, 180 mu g; or placebo at 4 separate visits. Protection against EIB was evaluated as the maximum percentage decrease in forced expiratory volume in I second (FEV1) from the preexercise value after exercise challenge tests (6-minute treadmill) conducted 15 minutes and 4, 8. and 12 hours after administration of the dose.Results: The maximum percentage decrease in FEV1 after the 4-hour exercise test (primary efficacy variable) was significantly less for formoterol, 12 and 24 mu g, vs placebo (P <.001 for both) or albuterol (P =.016 and .010, respectively); albuterol was not significantly different from placebo. Formoterol, 12 and 24 mu g, differed from placebo at 8 hours (P =.002 and .001, respectively), with a smaller difference between albuterol and placebo (P =.045). Rescue medication use and a high dropout rate may have biased treatment differences at later time points. Protection against EIB (< 20% maximum decrease in FEV1) across all time points was observed for 17 (77%) of 22 and 17 (74%) of 23 children with formoterol, 12 and 24 mu g, respectively, compared with 8 (35%) of 23 with albuterol and 6 (27%) of 22 with placebo.Conclusions: Single doses of formoterol, 12 or 24 mu g, are effective in protecting against EIB in children, affording a statistically significantly greater protective effect than placebo or albuterol.

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 mug 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 mug and 24 mug than for patients receiving placebo (all Pless than or equal to0.0062). 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 mu g, 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.

OBJECTIVES:To compare the onset and magnitude of bronchodilation after dry powder inhalations of formoterol fumarate (Foradil Aerolizer) versus salmeterol xinofoate (Serevent Diskus) with respect to normalized (*) forced expiratory volume in 1 s area under the curve 0 to 1 h after inhalation (FEV1 AUC*0-1 h).DESIGN:A double-blind, double-dummy, multicentre, randomized, placebo controlled, single-dose, five-period crossover study.SETTING:Five centres in four countries - one centre each in France, Greece and Italy, and two centres in the Netherlands.PATIENTS:Forty-seven patients aged 42 to 80 years (mean age 63.5 years) with chronic obstructive pulmonary disease (COPD) stage II and III, and mean baseline FEV1 1.17 L (range 0.56 to 1.77 L).INTERVENTIONS:Patients inhaled single doses of formoterol dry powder (12 and 24 mg), single doses of salmeterol (50 and 100 mg) and matching placebo on five separate days.MAIN RESULTS:The estimates of treatment difference in absolute terms (0.086 L) and percentage change from predose baseline (7.8%) for the primary end point, FEV1 AUC*0-1 h, showed that formoterol 12 mg was statistically significantly superior to salmeterol 50 mg (P=0.0044 and P=0.0021, respectively). In addition, both doses of formoterol were statistically superior to placebo for both absolute improvement and percentage change (P=0.0001). The analysis of secondary variables also confirmed the superiority of formoterol over salmeterol.CONCLUSIONS:Formoterol is associated with a faster onset of bronchodilation than salmeterol in patients with COPD.

Objective: The aim of this study was to determine the relative economic consequences of treating asthmatics with twice daily dry powder formoterol 12mg as compared with salmeterol 50mg from a societal perspective.