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| |  ATS: Budesonide/Formoterol Demonstrates Both Health Status and Lung Function Benefit in Chronic Obstructive Pulmonary Disease By Peggy Peck SEATTLE, WA -- May 27, 2003 -- In a large open-label study comparing budesonide/formoterol delivered in a single inhaler versus monotherapy with either budesonide or formoterol, both lung function and health status of patients with chronic obstructive pulmonary disease (COPD) improved significantly in the combination inhaler group. Formoterol monotherapy also demonstrated significant improvement in lung function compared to placebo, according to results presented here at American Thoracic Society International Conference. The findings were presented in a pair of studies based on the same study cohort. Both were featured in a poster discussion session May 19th. In the pulmonary function study, patients randomized to combination therapy "had a 14.1% improvement in FEV1 compared to placebo, an 11.3% improvement compared to budesonide alone, and a 5.4% improvement compared to formoterol alone," said Peter MA Calverly, MD, FRCP, FRCPE, professor of medicine and pulmonary rehabilitation, University of Liverpool, United Kingdom. In the second study, the combination therapy demonstrated significant improvement on a disease-specific health questionnaire compared to either monotherapy or placebo. "And the improvements in health status not only came on top of treatment optimization, but these improvements were maintained over 12 months," said lead author Peter W. Jones, PhD, FRCP, division of physiological medicine, St George's Hospital Medical School, London, United Kingdom. One thousand twenty-two patients at centers in 15 countries were enrolled in the AstraZeneca-funded study. Seventy-five percent of the patients were men and the mean age was 64. The median time from COPD diagnosis was 6 years. The mean baseline FEV1 was 0.99L 9 (36% of predicted normal) before optimization. Forty-eight percent of patients were previously treated with inhaled corticosteroids at a mean daily dose of 840 µg. Two hundred fifty-four patients were randomized to combination inhaler, 257 to budesonide, 255 to formoterol, and 256 to placebo. Patients were followed for 12 months. In the lung function study, budesonide/formoterol therapy maintained a higher morning peak expiratory flow (PEF) than budesonide, formoterol, or placebo and use of the combination inhaler was also associated with higher evening PEF. The combination inhaler reduced the risk of withdrawal by 27% versus budesonide, 39% versus formoterol, and 39% compared to placebo. Withdrawals due to worsening COPD were reduced by 39% versus budesonide, 56% versus formoterol, and 60% versus placebo. In the health status analysis, patients taking combination therapy demonstrated significant improvement in symptoms, activity, and impacts domains as measured by the St. George's Respiratory Questionnaire. "All treatment groups improved initially, but only the budesonide/formoterol group sustained the improvement for 12 months," said Dr. Jones. "Taking this therapy patients simply felt better," he said.
[Study title: Budesonide/Formoterol in a Single Inhaler Sustains Improvements in Lung Function over 12 Months Compared with Monocomponents and Placebo in Patients with COPD. Abstract 418] and [Study title: Budesonide/Formoterol in a Single Inhaler Improves Health Status in Patients with COPD. Abstract 419]
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