American Thoracic Society: Budesonide/Formoterol in Asthma
Speaker: Anthony D. P’Urzo, MD, MSc, Family Physician and Director, Primary Care Asthma Clinic, and Lecturer, Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada.
The combination of AstraZeneca’s budesonide (Pulmicort®) and formoterol (Oxis® [BUD/FORM]) (Symbicort®, Single Inhaler Therapy™, AstraZeneca, Canada), administered for both maintenance and relief in patients with asthma, reduced the exacerbation burden, compared with salmeterol plus propionate (SAL/FLU) (Glaxo-SmithKline) in a real-life setting.
Because the burden of asthma is most apparent during an exacerbation, researchers assessed the number of exacerbations, unscheduled visits leading to a treatment change, oral steroid days, and emergency visits or hospital days to compare BUD/FORM for maintenance or as needed (p.r.n.) or SAL/FLU twice daily plus (i.e., albuterol), as needed, over a 12-month period. This randomized, open-label study included 2,143 adolescents and adults with asthma, with a 73% predicted mean forced expiratory volume/second (FEV1) and mean inhaled corticosteroids 884 mcg/day.
Patients were given a starting dose of BUD/FORM 160/45 mcg two inhalations twice daily and as needed or SAL/FLU 50/250 mcg twice a day plus as needed. From the fourth week, maintenance treatment was titrated for both groups in accordance with the instructions of the attending physicians.
A total of 1,076 patients were randomly enrolled in the SAL/FLU group, and 921 patients completed the study; 1,067 patients were randomly assigned to receive BUD/FORM, and 945 patients completed the study.
Patients receiving BUD/FORM experienced fewer exacerbations (0.25 events per patient) than the SAL/FLU patients (0.31 events per patient). The BUD/FORM patients made 117 unscheduled visits that led to a treatment change, and the SAL/FLU patients made 154 unscheduled visits that led to a treatment change, for a 24% reduction favoring BUD/FORM usage. The BUD/FORM patients took oral steroids for 1,980 days, and the SAL/FLU patients took them for 2,978 days, resulting in a 34% reduction in usage favoring BUD/FORM.
Patients taking BUD/FORM made 38 emergency visits and spent 59 days in the hospital, and the SAL/FLU patients made 45 emergency visits and spent 94 days in the hospital, thereby resulting in a reduction of 16% for emergency visits and a 37% decrease in hospital length of stay with BUD/FORM.
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Tiotropium Bromide in Chronic Obstructive Pulmonary Disease
Speaker: Andre-Bernard Tonnell, MD, Pulmonologist and Professor of Medicine, Service de Pneumo-Immuno-Aller-gologie, Centre Hospitalier, Universitaire de Lille, Lille, France.
Long-term maintenance with tiotropium bromide inhalation powder (Spiriva®, HandiHaler®, Boehringer Ingelheim/Pfizer) provided significant improvements in health-related quality-of-life (HRQOL) measures in patients with chronic obstructive pulmonary disease (COPD).
A randomized, double-blind, placebo-controlled study was designed to assess the effects of tiotropium, a once-daily anti-cholinergic agent with prolonged M3-receptor antagonism, on HRQOL in patients with COPD. A total of 554 COPD patients were enrolled in the study and were randomly assigned to take tiotropium or placebo once daily for nine months.
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The primary endpoint was the response rate, as determined by the percentage of patients showing more than four points of improvement at the end of the study. The Saint George’s Respiratory Questionnaire was used to measure the endpoint. This tool consisted of three components (social, physical, and psychological). Responses were rated on a scale of 0 to 100, with 100 being the worst possible state.
HRQOL was also evaluated by the newer, simplified eight-item Visual Simplified Respiratory Questionnaire and by parameters of lung function, including forced expiratory volume in one second (FEV1), forced vital capacity (FVC), inspi-ratory capacity (IC), slow vital capacity (SVC), and forced inspiratory volume in one second (FIV1), measured throughout the treatment period.
At nine months of follow-up, the primary endpoints of a four-point increase in the Saint George Questionnaire were reached by 59.1% of patients taking tiotropium and by 48.2% of patients taking placebo. Patients who were using tiotropium also had higher mean Visual Questionnaire scores.
Patients receiving tiotropium experienced significant improvements in lung function compared to placebo-treated patients, as shown in all measures of lung function assessed. This effect was comparable in all of the tiotropium patients whether or not they received inhaled corticosteroids and irrespective of their disease severity or reversibility status at entry into the study.