Breo Ellipta Inhaler Slows Worsening Of COPD
Background: Breathing tests are used to measure how the lungs work (called lung function). Lung function normally worsens (declines) with aging. In those with COPD and who continue to smoke, there is a more rapid worsening (decline) in lung function. However, stopping smoking slows down this process.
There has been controversy whether inhaled medications slow down worsening in those with COPD.
Study: Dr. Peter Calverley from the University of Liverpool in the United Kingdom and colleagues published the effects of four different inhaled medications on changes in breathing test results. All subjects had moderate COPD (FEV1 between 50 – 70% of the predicted value) and either a history of heart disease or a significant risk of developing heart disease. The study was called SUMMIT (Study to Understand Mortality and Morbidity).
Subjects were recruited for the study from 43 different countries. Each received one of four inhaled treatments once a day in a dry powder inhaler called Ellipta: 1. placebo (sham or pretend medication); 2. fluticasone furoate (an inhaled corticosteroid) at a dose of 100 mcg; 3. vilanterol – a long-acting beta-agonist bronchodilator at a dose of 25 mcg; and 4. a combination of fluticasone furoate and vilanterol (brand name is Breo).
The study results were published in the January 1, 2018, issue of the American Journal of Respiratory and Critical Care Medicine (volume 197; pages 47 – 55. The study was supported by the pharmaceutical company GlaxoSmithKline which makes the different inhaled medications used in the study.
Results: Of the 16,485 subjects who completed the study, 75% were men, and 47% were current smokers. 1,037 subjects died during the study which lasted for one year and eight months. The changes in breathing tests as measured by how much air was exhaled in one second (called FEV1) are shown in the figure below. As expected, the decline in FEV1 was faster in current smokers.
Professor Peter M. A. Calverley of the University of Liverpool
The above figure shows that there were significantly lower rates of worsening (decline) in those taking fluticasone furoate (red boxes) and the combination of fluticasone furoate and vilanterol (blue triangles) compared with placebo (black circles).
Conclusion: The authors concluded that in those with moderate COPD and at risk for heart disease, the inhaled corticosteroid (fluticasone furoate) by itself or combined with a long-acting bronchodilator (vilanterol) slows worsening (or reduces the rate of decline) of lung function.
My Comments: According to experts on COPD (called GOLD committee), the two major reasons to prescribe inhalers for those with COPD are to reduce shortness of breath and to reduce the risk on a flare-up (called an exacerbation).
For at least 20 years or more, research studies have evaluated whether a specific treatment, such as a long-acting inhaler medication, slows worsening (decline) in lung function. The SUMMIT study is one of the first to show that an anti-inflammatory inhaler containing a corticosteroid, alone or when combined with a long-acting bronchodilator, DOES slow worsening of lung function.
The combination of fluticasone furoate and vilanterol is currently approved in the United States to reduce the risk of a COPD flare-up. Hopefully, this treatment would also slow down the expected worsening in shortness of breath experienced by many individuals with COPD.
Changes in FEV1 in each treatment arm. Blue triangles are the combination of fluticasone and vilanterol (Breo Ellipta); black circles are placebo.