Adjustable maintenance dosing: suitability of budesonide/formoterol in a single inhaler and overview of a clinical study programme

Inhaled budesonide/formoterol is effective and well tolerated in the treatment of asthma. Unlike salmeterol, formoterol is a full beta(2)-receptor agonist and exhibits dose-dependent bronchoprotection across a wide dose range. Budesonide/formoterol adjustable maintenance dosing (i.e. varying the number of inhalations from a single inhaler) is suitable for maintaining asthma control with an adequately low dose of medication. The first in a series of international, randomised, multicentre, open-label studies, evaluating adjustable maintenance dosing with budesonide/formoterol has been completed. Following 1-month run-in on budesonide/formoterol fixed dosing (two inhalations bid), patients either continued this regimen or received budesonide/formoterol adjustable maintenance dosing (2-8 inhalations daily) for 3-6 months. Doses were adjusted according to asthma control but varied between countries to reflect appropriate clinical practices. The studies evaluate a wide range of outcomes: exacerbations/treatment failure, health-related quality of life, health economic variables and tolerability, and will provide a robust evaluation of adjustable maintenance dosing with budesonide/formoterol.