The effect of adding inhaled corticosteroids to tiotropium and long-acting beta2-agonists for managing chronic obstructive pulmonary disease

Chronic obstructive pulmonary disease (COPD) is a lung disease which includes the conditions chronic bronchitis and emphysema. COPD is characterised by blockage or narrowing of the airways. The symptoms include breathlessness and a chronic cough. COPD is an irreversible disease that is usually brought on by airway irritants, such as smoking or inhaled dust.

Long-acting beta2-agonists and tiotropium are two types of inhaled medications that help widen the airways (bronchodilators) for up to 12 to 24 hours. These bronchodilators are commonly used to manage persistent symptoms of COPD. They can be used in combination or on their own. Patients with severe COPD who suffer ongoing worsening of symptoms are recommended to add anti-inflammatory 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 COPD are unclear.

This review found one study, involving 293 patients, comparing the long-term efficacy and side effects of combining inhaled corticosteroid with tiotropium and a long-acting beta2-agonist. In this study there were not enough patients for us to be able to draw any firm conclusions as to whether combining inhaled corticosteroid with tiotropium and the long-acting beta2-agonist is better or worse than using only tiotropium and the long-acting beta2-agonist. More long-term studies need to be done in order to better understand the effect of treatment with inhaled corticosteroid, tiotropium and a long-acting beta2-agonist.

Authors' conclusions: 

The relative efficacy and safety of adding inhaled corticosteroid to tiotropium and a long-acting beta2-agonist for chronic obstructive pulmonary disease patients remains uncertain and additional trials are required to answer this question.

Read the full abstract...
Background: 

Long-acting bronchodilators comprising long-acting beta2-agonists and the anticholinergic agent tiotropium are 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 beta2-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 beta2-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 beta2-agonist for COPD.