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Objective: A new epinephrine hydrofluoroalkane (HFA) asthma metered-dose inhaler (MDI) was reformulated to replace the previously marketed epinephrine chlorofluorocarbon (CFC) MDI. In addition to the HFA propellant change, several enhanced modifications (i.e. changed from solution to suspension, 43% dose reduction, etc.) were made to the formulation of epinephrine HFA MDI. This study evaluates the 6-month long-term safety and efficacy profile of the new epinephrine HFA MDI. Method: The long-term safety study consists of two 3-month, multi-center, double- or evaluator-blinded, parallel-group, placebo, and active controlled stages. In each stage, subjects aged ≥12 years with intermittent or mild-to-moderate persistent asthma were randomized to receive epinephrine HFA (2 × 125 mcg/inhalation), placebo HFA, or epinephrine CFC (2 × 220 mcg/inhalation). Bronchodilator efficacy was assessed in Stage 1 and was determined primarily by the change in the forced expiratory volume in 1 s (ΔFEV1) at Week 12, relative to the same day baseline. Results: The primary efficacy endpoint (AUC0-6hrs of %ΔFEV1 at Week 12) for epinephrine HFA (47.3 ± 54.2) closely paralleled those for the active control, epinephrine CFC (41.0 ± 43.4). Both groups were found to be overall comparable in bronchodilator efficacy. Both also showed low incidence rates of AEs with tremor being most commonly reported for epinephrine HFA. All AEs found were non-serious and non-significant. The observed changes in vital signs, ECG, serum glucose, and potassium were minimal and not clinically relevant. Conclusion: This study demonstrated that the new epinephrine HFA is overall comparable, in both safety and efficacy, to the previous epinephrine CFC. [ABSTRACT FROM AUTHOR]

The severity of asthma often varies throughout the course of the disease. At times the symptoms and underlying inflammation that are characteristic of asthma can worsen. Thus during an episode of viral-induced asthma or during a seasonal increase in asthma severity, a patient may be directed to increase his or her dosage of asthma controllers (i.e., inhaled corticosteroid) or add a long-acting bronchodilator (or other controller medications such as antileukotrienes) to manage symptoms, as recommended in guidelines published by the National Institutes of Health (NIH). Similarly, when symptoms are stable, decreasing dosages or discontinuing certain medications may be appropriate. The recent introduction of a combination product, of a long-acting bronchodilator formulated in the same dry powder device with an inhaled corticosteroid raises new challenges for the step care approach to asthma management recommended by the NIH in 1997. Although unquestionably more convenient for the patient, a combination formulation has the potential to decrease the flexibility required to successfully manage asthma over long periods. In addition, controversy exists regarding long-acting beta-agonists alone because their regular use may mask inflammation in the lung and decrease responsiveness to the bronchodilating effects of rescue medications (i.e., short-acting beta-agonists). The purpose of this article is to help physicians make informed therapeutic decisions for their patients with asthma. It focuses on the advantages and potential disadvantages of using combination products, which contain both an inhaled corticosteroid and a long-acting beta-agonist in the context of the NIH step care approach. Recent publications outlining the use of other add-on controller medications are also discussed. [ABSTRACT FROM AUTHOR]