A therapy for chronic obstructive pulmonary disease (COPD) approved this past spring has shown positive results once again in the latest clinical trial to test its safety and efficacy.
The drug known as tiotropium, marketed as Spiriva (Boehringer Ingelheim), was approved by the Food and Drug Administration (FDA) in May of this year. It's indicated for the treatment of bronchospasm associated with COPD, and is available in the form of an inhalation device, as well as capsule form. Tiotropium works as a anticholingeric medication; that is, it blocks the action of the parasympathetic nerves in COPD. These nerves play key roles in the function of the airways, and when they are hyperactive, the result can be the airway restriction that is a common characteristic of COPD.3
Tiotropium's Efficacy Evaluated
Two facets of a clinical trial testing the effectiveness of tiotropium were unveiled at a European medical conference in September,1,2 and doctors found the drug provided effective symptom relief and long-lasting improvements in lung function, compared to placebo, a non-therapeutic intervention used as a comparison as part of a clinical trial protocol.
"Current guidelines state that exacerbations, or acute worsening of disease symptoms, are a key target for COPD therapy because they severely impact quality of life, and are responsible for the majority of health care costs associated with treating COPD," explained Daniel Dusser, MD, head of Pneumology at Hôpital Cochin in Paris, and the study's principal investigator.
In the trial of more than 1,000 patients with COPD at 177 medical institutions throughout France, tiotropium's effectiveness was tested head-to-head with a placebo. The investigators found that tiotropium significantly reduced the average number of COPD exacerbations by more than a third per patient, per year (1.57 exacerbations per patient, per year among those taking tiotropium vs. 2.41 exacerbations per patient, per year among those given placebo).
Similarly, the average number of days that patients experienced COPD exacerbations was significantly lower in those taking tiotropium versus those taking placebo (21.1 days, on average, in tiotropium patients vs. 33.3 days, on average, in placebo patients)—a reduction of 37%.
Dusser and his team also found that those taking tiotropium experienced longer periods of time before they had their first exacerbation.
Health Care Resource Utilization
As part of the trial's second primary objective, Dusser and his colleagues found that using tiotropium was linked to significantly fewer visits to the hospital or a physician. Specifically, phone calls to physicians dropped 53% and unscheduled physician visits plunged 41% in tiotropium patients. Those taking the drug also had fewer hospital admissions—down 27%. Significantly fewer patients taking tiotropium needed additional respiratory medications for their exacerbations (called rescue medications)— approximately 30% of patients taking tiotropium needed these rescue medications compared to about 42% of those taking placebo. Significantly fewer courses of antibiotics and oral steroids were needed for tiotropium patients (-34% and -24%, respectively), and significantly fewer patients needed oxygen during their therapy (2.6% vs. 3.5%, respectively), reported Dusser and his colleagues.
"The results of this study reinforce the effectiveness of Spiriva as a maintenance therapy that significantly reduces COPD exacerbations, improving patient quality of life and reducing the related burden on health resources," Dusser maintained.
Exacerbations in this trial were defined as the appearance of at least one COPD symptom, such as increasingly severe shortness of breath, as well as cough or sputum production, fever or a new chest X-ray abnormality that required a new prescription; or an increase in the dose of other therapies like beta-2 agonists, antibiotics, corticosteroids or bronchodilators.
New Indication Recognized
COPD is currently classified as the fourth leading cause of death in the United States. It is a term used to describe a range of diseases that fall into the same category, primarily emphysema and chronic bronchitis. The main cause of the disease is cigarette smoking, but the consistent inhalation of lung irritants like pollution, dust or chemicals is also a known risk factor.4
Earlier this year following its approval, tiotropium was added to treatment guidelines for COPD. Two government health agencies included the drug in a list of recommendations focusing on the use of long-acting bronchodilators as first-line treatment for COPD.5
1. Dusser D, Bravo ML, Iacono P. Tiotropium reduces COPD exacerbations: The MISTRAL study. 2004 European Respiratory Society (ERS) Meeting. 2004 Sep 4-8. Glasgow, Scotland.
2. Dusser D, Bravo ML, Iacono P. Tiotropium reduces health resource utilization associated with COPD exacerbations. 2004 European Respiratory Society (ERS) Meeting. 2004 Sep 4-8. Glasgow, Scotland.
3. Coulson FR, Fryer AD. Muscarinic acetylcholine receptors and airway diseases. Pharmacol Ther 2003 Apr;98(1):59-69.
4. National Heart, Lung and Blood Institute. National Institutes of Health (NIH). Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/Copd/Copd_WhatIs.html. Accessed October 15, 2004.
5. Pauwels RA, Buist AS, Calverley PM, Jenkins CR, Hurd SS;GOLD Scientific Committee. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) Workshop Summary. [Revised 2003 Jul]. Am J Respir Crit Care Med 2001 Ap;163(5):1256-76.
John Martin is a long-time health journalist and an editor for Priority Healthcare. His credits include coverage of health news for the website of Fox Television's The Health Network, and articles for the New York Post and other consumer and trade publications.
