COPD research continues to be conducted in greater scales than in previous years. With new discoveries, scientists are creeping towards a breakthrough in medicine. And this year, COPD researchers had yet another breakthrough that excites every member of the COPD patient community.
Recently, GlaxoSmithKline (GSK), one of the largest pharmaceutical companies in the U.S. leading the research on COPD, concluded their three-year study that took place at over 400 sites across the globe. The study was called TORCH, which stood for “Towards a Revolution in COPD Health.” Along with several well-known COPD researchers, GSK studied approximately 6,200 patients, ranging from the ages of 40 and 80 with moderate or severe COPD, and who had smoked a pack of cigarettes a day for at least ten years.
The overall purpose of the study was to see if the GSK product Advair® significantly elongated the lives of the COPD patients who used it. Advair®, a combined inhaled corticosteroid and long-lasting bronchodilator, has been associated with significantly improving wheezing and other symptoms of COPD patients and reducing pulmonary inflammation, especially in combination with supplemental oxygen. With the study, researchers also hoped to study COPD co-morbidities as well as the patients’ quality of life.
The Study
In order to study the effectiveness of the drug, the researchers had to prove that it reduced the mortality from COPD of all causes—including co-morbidities—by 4.3%. Other factors taken into effect were exacerbations, the patient’s overall health status, their need for supplemental oxygen, their lung function, and any adverse reactions to medicine. The quality of life was measured by the answers given by the patient in a questionnaire called the St. George’s Respiratory Questionnaire, which inquired about the patient’s overall well-being and satisfaction with life. Researchers are well aware of the side effects many COPD patients have, including depression and anxiety. That is why it was important for them to monitor if the drug caused any improvement in the quality of life of the patient.
The study was conducted in a double-blind fashion, meaning that neither the doctors nor the participating patients knew who was receiving the actual treatment, or who was receiving the placebo—a substance with no pharmacological effect. Patients’ treatments were picked at random, and each participant received only one type of treatment: either a medicinal treatment or a placebo. Those who received medicinal treatment received one of three types that were distributed. A group of patients took salmeterol, which is sold commercially as Serevent®. Another group received fluticasone propionate, also known as Flonase®, which is available in generic form. The third group was testing the effects of a combination of both salmeterol and fluticasone propionate—the components of Advair®. During the study, patients participating ceased taking their regular medication and replaced it with their assigned trial treatment. Throughout their participation, they made sixteen visits to the study clinic, once every three months, in order to monitor their progress.
The Results
The results of the TORCH study were positive, and they spread excitement throughout the scientific research community. According to the information released by GSK, the TORCH study showed a 25% decrease in exacerbations of patients using Advair®1. Also, those who took Advair® in the study remained above the baseline measurement they had before they took part in the study—demonstrating that Advair® did in fact improve the quality of life and symptoms of COPD patients . Instead of the patient’s symptoms worsening throughout the three years of the study (as would normally happen to a COPD patient), the patients using Advair® reported less symptoms than before joining the study, and continued that trend through the end of the trial.
After the conclusion of the study, however, researchers saw that throughout the study, the number of placebotaking participants declined. They attributed this to the fact that many patients—seeing that their trial medication was not working—decided to return to their normal medication, and reduce the inflamed effects of their COPD. Because the number of individuals in the control group reduced, the numbers in the study were skewed because they no longer had a solid control group to measure against when analyzing the effects of the other three drugs. This caused the results to be inconclusive in proving what they initially set out to prove.
Although Advair cannot claim its effectiveness in lengthening the lives of COPD patients as a fact on their prescription information, the study was not done in vain. According to patient testimonials of those who were in the group that did take Advair, the drug significantly improved the effects of their disease. Patients receiving the medicines claimed to have had a higher quality of life and had fewer exacerbations throughout the study. And the general consensus of the public demonstrates that Advair’s union of an inhaled corticosteroid and long-lasting bronchodilator is in fact effective in reducing the symptoms of COPD.
What Research Does for Us
Studies, like TORCH that are conducted by researchers, are a very important step in the path of discovering a cure for COPD. They show us that COPD is in fact treatable. They renew the hope for finding a remedy, and potentially a cure, for COPD. Without trial and error, researchers would not be able to narrow their findings into a potential solution: a drug that would remove COPD as a major concern for over 24 million affected individuals in the U.S. And without clinical trials, GSK and other pharmaceutical companies would not have been able to develop the drugs that help alleviate the symptoms of COPD patients today. That is why it is important for COPD patients to consider participating in clinical trials, to take part in finding a cure for COPD.
1Landmark study shows important benefits of SeretideTM treatment for patients with fatal lung disease, COPD.” New England Journal of Medicine. Issued Wed, Feb 21, 2007. London, UK. http://www.gsk.com/ControllerSe rvlet?appId=4&pageId=402&newsid=984.
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