A publicly funded cross-Canada clinical trial has revealed that combining the inhalers SpirivaTM (tiotropium) and AdvairTM (fluticasone / salmeterol) results in improved quality of life, improved lung function, and fewer hospitalizations among people with severe Chronic Obstructive Pulmonary Disease (COPD).
More than five per cent of Canadians over the age of 55 have been diagnosed with COPD, an incurable disease also referred to as emphysema and chronic bronchitis.
“We knew that many doctors were prescribing multiple different inhalers to patients, but this is the first study to evaluate the safety and efficacy of this practice,” said lead author Dr. Shawn Aaron, a Senior Scientist at the Ottawa Health Research Institute, Associate Professor of Medicine at the University of Ottawa, and Respirologist at The Ottawa Hospital.
The randomized double-blind study followed 449 patients for one year in 27 hospitals and medical centres across Canada. Patients who received SpirivaTM and AdvairTM scored twice as high in a quality of life assessment compared to patients taking SpirivaTM and placebo. The combination therapy also decreased the number of hospitalizations for COPD by 47 per cent and increased lung function by five per cent, compared to SpirivaTM and placebo.
“Although a five per cent increase in lung function may not sound like a lot, you have to remember that these people may only have 25 per cent of normal lung function to begin with,” said Dr. Aaron. “This could allow some people to walk around the block for the first time in years.”
The study also evaluated disease exacerbations and serious adverse effects. No significant differences were observed. A third arm of the study looked at patients taking SpirivaTM plus salmeterol (one component of AdvairTM). This combination was not as beneficial as SpirivaTM plus AdvairTM.
Although SpirivaTM and AdvairTM are made by pharmaceutical companies, the study was conceived, designed, and conducted by independent academic researchers funded by public agencies ($1.5 million from the Canadian Institutes of Health Research (CIHR) and $50,000 from the Ontario Thoracic Society).
“Because these two drugs are made by different companies, it is unlikely that either company would be inclined to initiate this sort of clinical trial,” said Dr. Aaron. “But as independent clinicians, we can do research without restrictions to determine the best approaches for improving health.”
“Given that the number of individuals with COPD is likely to increase with our aging population, the results of this study should help improve the quality of life for patients affected with COPD and benefit their families and the health care system,” said Dr. Peter Liu, Scientific Director of the CIHR Institute of Circulatory and Respiratory Health.
The study will be published in the online version of Annals of Internal Medicine, established by the American College of Physicians. It will appear in the print edition on April 17, 2007.
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