An randomized clinical trial (RCT) in the Annals of Internal Medicine provides evidence favoring use of inhaled corticosteroids (ICS) for moderate and severe COPD. Entry criteria included: fev1 less than 65% predicted, at least 10 pack years of cigarette use, and a history of at least one exacerbation of COPD in the preceding year.
Three groups ( about 150 patients per group) were compared:
tiotropium plus placebo
tiotropium plus salmeterol
tiotropium plus salmeterol-futicasone (Advair)
The third group had fewer hospitalizations, improved lung function and a better score on a quality of life question indicator.Numerically there were fewer exacerbations in the triple therapy group but it did not reach statistical significance.
The Advair manufacturers have to be pleased with some relatively good news after bad publicity generated by the SMART trial and subsequent publications by the Salpter family in regard to the use of ICS inhalers in asthma.
I suspect this trial will not bring about any major change in the way pulmonary physicians treat COPD. The recent well publicized TORCH trial compared salmeterol,fluticasone and the combination of the two and demonstrated fewer exacerbations with the combo treatment but did find more pneumonia in the group that received the ICS. The GOLD guidelines already have recommended adding a ICS to COPD patients with severe disease who have a history of repeated exacerbations. ("Severe" according to GOLD is less than 50% fev1 and very severe is less than 30%)
Both the TORCH trial and the current one included patients with FEV1 values greater than 50% of predicted which is the GOLD cut point for severe COPD so possibly more patients may be thought to be candidates for ICS according to the results of these two studies.