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Currently, patients have to keep track of doses to determine when to replace their metered-dose inhalers (MDIs). This study evaluated the performance and patient satisfaction of a novel MDI with an integrated dose counter. In an open-label study at 38 outpatient centres, patients > or =12 years old with asthma or chronic obstructive pulmonary disease (COPD) received two actuations of fluticasone propionate/salmeterol 125/25 microg (115/21 microg ex-actuator) hydrofluoroalkane (ADVAIR) HFA) via MDI with counter twice a day until all 120 actuations were completed. Concordance between counter and diary recordings in patients who reported use of > or =90% of labelled actuations (completer population, n = 228) was high (discrepancy rate of 0.94%) and the incidence of device firing without changes in counter readings was low (0.13%). Mean expected actuations based on canister weights (114) were slightly lower than mean counter (121) and diary reported actuations (120). Upon study completion, 95% of patients were satisfied with the dose counter and 92% agreed it would help prevent them from running out of medication. Safety assessments (intent-to-treat population, n = 237) indicated that the drug was well tolerated. This integrated MDI counter may help patients maintain better disease control by enabling them to accurately track their medication supply.

Currently available metered dose inhalers (MDIs) do not track the remaining number of doses, indicating the need for a device that accurately monitors medication use. In an open-label study at 37 outpatient centers, patients > or =4 years old with asthma or chronic obstructive pulmonary disease requiring short-acting 32-agonists received two actuations of albuterol hydrofluoroalkane (HFA) [Ventolin HFA: GlaxoSmithKline], 90 microg twice daily, via a novel MDI with an integrated dose counter until all 200 actuations were completed. Concordance between counter readings, diary card-recorded actuations, and canister weights were measured in patients who completed > or =90% of the labeled actuations (n = 224). Adverse events and patient satisfaction were assessed in the intent-to-treat population (n = 268). In 43,865 recorded actuations, 333 counter versus diary discrepancies occurred (discrepancy rate of 0.76%), and 88% of discrepancies were by one to two actuations. Forty-seven percent of patients had no discrepancies. Incidence of the device firing without changes in counter readings was very low (0.09%). Mean expected actuations based on canister weights (184) were slightly lower than mean counter and diary-reported actuations (200 each). At baseline, 62% of patients reported anxiety about not knowing the quantity of medication remaining in their inhaler. On study completion, 92% expressed satisfaction with the dose counter and 92% agreed it would help prevent them from running out of medication. The adverse event profile showed that albuterol HFA was well tolerated. Integrated MDI counters are a useful and reliable tool for tracking a patient's medication supply.

From a third-party payer perspective, this analysis shows that based on increased efficacy and only a slight increase in cost, twice-daily treatment with salmeterol/fluticasone propionate is more cost effective than once-daily treatment with montelukast as initial maintenance therapy for persistent asthma. This finding complements the results of the clinical analyses indicating that treatment of both inflammation and bronchoconstriction with products such as salmeterol/ fluticasone propionate may be more cost effective as initial maintenance asthma therapy than the use of leukotriene modifiers such as montelukast.