Background Long-acting bronchodilators comprising long-acting beta(2)-agonists and the anticholinergic agent tiotropiumare commonly used, either on their own or in combination, for managing persistent symptoms of chronic obstructive pulmonary disease. Patients with severe chronic obstructive pulmonary disease who are symptomatic and who suffer repeated exacerbations are recommended to add inhaled corticosteroids to their bronchodilator treatment. However, the benefits and risks of adding inhaled corticosteroid to tiotropium and long-acting beta2-agonists for the treatment of chronic obstructive pulmonary disease are unclear. Objectives To assess the relative effects of adding inhaled corticosteroids to tiotropium and long-acting beta2-agonists treatment in patients with chronic obstructive pulmonary disease. Search strategy We searched the Cochrane Airways Group Specialised Register of trials (February 2011) and reference lists of articles. Selection criteria We included parallel group, randomised controlled trials of three months or longer comparing inhaled corticosteroid and long-acting beta(2)-agonist combination therapy in addition to inhaled tiotropium against tiotropium and long-acting beta2-agonist treatment for patients with chronic obstructive pulmonary disease (COPD). Data collection and analysis Two review authors independently assessed trials for inclusion and then extracted data on trial quality and the outcome results. We contacted study authors for additional information. We collected information on adverse effects from the trials. Main results One trial (293 patients) was identified comparing tiotropium in addition to inhaled corticosteroid and long-acting beta(2)-agonist combination therapy to tiotropium plus long-acting beta2-agonist. The study was of good methodological quality, however it suffered from high and uneven withdrawal rates between the treatment arms. There is currently insufficient evidence to know how much difference the addition of inhaled corticosteroids makes to people who are taking tiotropium and a long-acting beta(2)-agonist for COPD. Authors' conclusions The relative efficacy and safety of adding inhaled corticosteroid to tiotropium and a long-acting beta(2)-agonist for chronic obstructive pulmonary disease patients remains uncertain and additional trials are required to answer this question.
