A drug designed to ease the symptoms of chronic obstructive pulmonary disease (COPD) that was approved by the FDA earlier this year has passed an evaluation by doctors in France. Results of a pair of studies, involving the drug tiotropium bromide (Spiriva), were released at a medical conference in Scotland last month.1,2 Tiotropium is an inhaled, anticholinergic medication that is indicated for use once per day to help maintain the symptoms of COPD.
COPD and Treatment Options
Chronic obstructive pulmonary disease is a progressive respiratory disease that is considered to be the fourth leading cause of death in the United States. It causes significant lung function deterioration and makes it hard to breathe. COPD refers to a group of diseases with similar symptoms: emphysema, chronic bronchitis, and asthma. Smoking, asthma, exposure to air pollution, genetic factors and respiratory infections are key causes of COPD.3
According to the study authors, tiotropium bromide is an inhaled medication that is aimed at providing significant and sustained improvements in lung function. Through targeting of a dominant reversible mechanism of COPD, cholinergic bronchoconstriction, tiotropium helps people with the disease breathe more easily by opening narrowed airways and helping to keep them open.
"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," said Daniel Dusser, MD, Head of Pneumology, at Hopital Cochin in Paris, who is also the study's lead investigator.
Targeting Disease Exacerbations
In the 1-year, placebo-controlled trial involving 1000 patients with COPD in 177 centres in France, tiotropium was shown to significantly reduce the frequency of COPD exacerbations compared to those in the study who took a placebo, a dummy medication with no therapeutic value. The difference in the number of COPD exacerbations was about 35% between the two groups. Additionally, the average number of days that patients had exacerbations was lower in the group taking tiotropium compared to those taking placebo (about 21 days versus about 33 days), a drop of about 37%.
Exacerbations in the study were defined as the onset of at least 1 clinical symptom; such as shortness of breath, cough or sputum production, fever, or appearance of abnormal x-ray images; in a 24-hour period that requires a new prescription or an increase in the dose of medication that a patient is taking.
Quality of Life Results
Patients taking tiotropium also tended to pay unscheduled visits to their doctor less often, as well as fewer phone calls to their physician, during the study compared to those taking placebo. The number of hospitalizations dropped by 27% for patients taking the medication. Significantly fewer courses of antibiotics and oral steroids were required for the patients taking tiotropium versus the group given placebo, Dusser and his colleagues found. And significantly fewer patients in the tiotropium group required supplemental oxygen.
"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 said.
1. Dusser D, Bravo ML, Iacono P. Tiotropium reduces COPD exacerbations: The MISTRAL study. 14th Annual Congress of the European Respiratory Society. 2004 Sep 4-8. Glasgow, Scotland.
2. Dusser D, Bravo ML, Iacono P. Tiotropium reduces health resource utilization associated with COPD exacerbations. 14th Annual Congress of the European Respiratory Society. 2004 Sep 4-8. Glasgow, Scotland.
3. National Center for Environmental Health. Centers for Disease Control and Prevention (CDC).
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.
