Chronic Obstructive Pulmonary Disease – the TORCH Study

Chronic obstructive pulmonary disease (COPD) is a condition affecting the lung. The lungs are two very important organs involved in our breathing. COPD is a disease of the smaller airways in the lungs. Before this new TORCH (TOwards a Revolution in COPD Health) study, only quitting smoking and long-term oxygen therapy have shown any improvements in patients with COPD. You may have heard of or been prescribed medications called inhaled corticosteroids (ICS) which have been used in many patients to help improve symptoms and decrease the number of disease episodes. Up until recently, there has been a lack of long-term studies supporting the ongoing use of these agents.

The TORCH study is a recent, randomised, large scale study involving a large number of COPD patients. Participants and study investigators were unaware of who received the experimental medication and who did not. The main goal of the study was to determine the impact of the salmeterol / fluticasone propionate combination (also called Seretide) against placebo on overall patient mortality. Other goals included: the rate of COPD exacerbations and the patient’s perception of their health status, overall mortality rates, requirements for long term oxygen therapy and progress of lung function. After three years of treatment, Seretide was associated with a significant decrease in mortality and patients reported improvements such as a better quality of life and decreased episodes of disease exacerbations. Why is treatment of COPD important?COPD is fast becoming an important public health problem, forecasted to become the third most common cause of death (following heart disease). If you suffer from COPD, you may experience shortness of breath, coughing or wheezing, limiting your ability to perform everyday tasks. To achieve the best control of COPD, any decreases in mortality / death rates must be accompanied by improvements in other aspects of health such as your quality of life. In addition to quitting smoking and oxygen therapy, recent findings have suggested that medications called inhaled corticosteroids (Eg Seretide) and/or long acting bronchodilators (Eg Serevent or Salmeterol) may help achieve optimal control. Corticosteroid medications are chemically similar to natural steroids that the body’s adrenal glands produce. They have traditionally been used in treatment of COPD because of their ability to suppress inflammation (a way in which the body reacts to injury, infection or irritation). This process is an important part of the COPD disease process. What is the TORCH study?The TORCH study is a global, well controlled three year study involving approximately 6200 patients with moderate-severe COPD. One of the largest studies of its kind, patients were randomly assigned to treatment with either Seretide, fluticasone propionate, salmeterol or placebo and followed over a three year period. Neither the patients or the investigators of the study were aware of who received the experimental medication and who received the placebo. To decrease any other factors likely to impact on the study, all long acting bronchodilators / corticosteroids were stopped greater than two weeks prior to the study.Primary goalThe primary goal of the study was to determine the effect of Seretide on mortality rates after three years of treatment, compared to placebo. Results from the TORCH study showed that after three years, patients receiving treatment with Seretide demonstrated a 17.5% decrease in mortality rates compared to patients who were not receiving Seretide treatment. This is known as the relative risk reduction, obtained by subtracting the number of patients receiving treatment (experiment event rate) from the number of patients not receiving the treatment (control event rate), divided by the control event rate. It gives us a percentage of the extent to which a treatment decreases your risk, compared to those not receiving treatment. The overall difference in event rates between the control and experiment groups was 2.6%. (This is also known as the absolute risk reduction).Secondary outcomes

• Frequency of exacerbations – Patients on Seretide experienced a 25% reduction in moderate and severe exacerbations of COPD each year, compared to placebo. There was also a significant reduction in exacerbations seen in patients on Seretide compared to salmeterol and fluticasone alone.
• Health related quality of life – All study patients reported an initial improvement in their quality of life, followed by steady deterioration over time. However, those on Seretide experienced improved lifestyle conditions for longer periods of time.
• Lung function – With progression of COPD, the lung tissue becomes irreversibly damaged and some lung function is lost. Patients treated with placebo demonstrated a loss in lung function of about 50mls of volume / year. On Seretide, an initial improvement in lung function was seen, which was sustained over the next three years.

Side effectsYou may be concerned about the effects of steroid treatment on the body. However, inhaled corticosteroids have effects primarily localised to the mouth, nose, throat and lungs, with minimal systemic side effects. All the different types of treatment used during the study were well tolerated, only associated with a small increased risk of lung infections (particularly pneumonias). However, the reliability of the reporting methods used (patients reporting their own symptoms) was questionable and further studies need to be performed to confirm this finding. Conclusion / Future directionsThe TORCH study has revealed favourable results with Seretide use in COPD patients. There is a clinically significant reduction in mortality with Seretide. This is achieved with minimal side effects and accompanied by improvements in quality of life. Further studies need to be conducted to examine the potential increase in lung infections associated with Seretide treatment. Overall, data from this study are very promising, providing much information regarding inhaled corticosteroid use in COPD patients. The study has also addressed important lifestyle factors that should always be remembered and optimally managed, to ensure that the best COPD management is provided.