Two large studies of hard outcomes in patients with chronic obstructive pulmonary disease (COPD) have been published this week and both failed to reach statistical significance.
The first study, published in the Annals of Internal Medicine compared tiotropium in combination with placebo, salmeterol or fluticasone and salmeterol. The primary endpoint was exacerbations requiring treatment with steroids or antibiotics. There were no statistically detectable differences between the three arms.
There were differences in some secondary outcomes such as improved lung function and reduced hospital admission however as the study was not significant for the primary end point these results should be interpreted with caution.
The second study, published in the New England Journal of Medicine compared placebo with salmeterol alone, fluticasone alone or a combination of salmeterol and fluticasone. The primary outcome was death from any cause with secondary outcome measures including lung function and frequency of exacerbations.
There were no statistically significant differences between the four groups in the study for the primary outcome. Secondary outcomes were statistically different when comparing the combination and placebo arms but once again these results should be interpreted with caution because the study was not significant for the primary end point.
Action: These trial results are both disappointing; they add nothing to the evidence base for treating COPD. Clinicians should continue to follow the current COPD guideline from the National Institute for Health and Clinical Excellence.