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Title: Tiotropium Significantly Improves Lung Function in Patients With Mild COPD

"Tiotropium Significantly Improves Lung Function in Patients With Mild COPD"

First prospective study to investigate the effect of Spiriva® in early stage COPD, an under-diagnosed condition affecting overall one in ten adults globally MUNICH, GERMANY -- September 12, 2006 -- Patients with mild* chronic obstructive pulmonary disease (COPD) treated with Spiriva® (tiotropium) experienced significantly improved lung function compared with patients receiving placebo, according to the results of a study presented today at the annual meeting of the European Respiratory Society (ERS) congress.1 This is the first prospective study to focus only on patients with mild COPD, confirming the efficacy of Spiriva® in this specific subset of the wider COPD population. Spiriva®, a long-acting inhaled anticholinergic medication, is the first inhaled treatment to provide significant and sustained improvements in lung function with once-daily dosing. Spiriva® positively impacts the clinical course of COPD, helping to change the way patients live with their disease.2,3 It is the most prescribed medication for the treatment of COPD in the world. "Early diagnosis and effective treatment in the milder stages of COPD is vital in preventing complications and worsening of symptoms over time, ideally helping patients to remain active," said Dr. Gunnar Johansson, general practitioner, Department of Public Health and Caring Sciences, Uppsala University, Sweden, and lead study investigator. "The results of this study show that patients with mild COPD could benefit significantly from treatment with Spiriva®." The study was a 12-week, randomised, double-blind, placebo-controlled trial of 224 patients with mild COPD.* Results showed significant improvement in all lung function assessments with Spiriva® compared with placebo (including FEV1 and FVC).1 The extent of improvements were similar to those observed in patients with moderate-to-severe COPD.1 Results showed that compared with treatment with placebo: • Spiriva® significantly improved FEV1 area under the curve (AUC0-2h) by 8.4%, p<0.0001 • Spiriva® significantly improved trough FEV1 by 6%, p<0.0001 Improvements were apparent 30 minutes after the first dose of Spiriva®, and were maintained over the 24 hour period and for the 12 week study duration.1 COPD is a progressive respiratory illness that causes significant deterioration of lung function and chronic breathlessness.4 COPD is often undiagnosed in its mild and moderate stages, with many patients wrongly attributing symptoms such as breathlessness to aging.5 600 million people worldwide already live with COPD, with its prevalence predicted to rise to become the world's third leading cause of death by 2020.6,7 A recent global analysis revealed almost 1 in 10 people has mild COPD.8 It is estimated that up to 50% of Americans and 75% of Europeans with COPD are undiagnosed.9,10 "COPD places a huge burden on society and the individual, but the disease can be treated and managed if it is caught early," said British Lung Foundation spokesperson Dr Mike Morgan. "The results of this study underline the importance of early diagnosis and treatment for anyone with COPD. People affected by the disease should be given every opportunity of maintaining higher levels of activity and their quality of life" The study was sponsored by Boehringer Ingelheim and Pfizer Inc. FEV1 (Forced Expiratory Volume in one second) is the volume of air that can be forcefully and rapidly exhaled in the first second from the beginning of exhalation. FEV1 is reduced in patients with COPD and is a key measure of lung function used to confirm diagnosis of COPD, following identification of risk factors and symptoms. It is measured in clinical practice using spirometry. FVC (Forced Vital Capacity) is the maximum volume of air that can be forcefully and rapidly expired after a maximal inhalation. The ratio of FEV1 to FVC is expressed in a percentage and provides clinicians with a useful index of airflow limitation. It is decreased in obstructed airways. About Spiriva® Spiriva®, a long-acting inhaled anticholinergic medication, is the first inhaled treatment to provide significant and sustained improvements in lung function with once-daily dosing. Spiriva® positively impacts the clinical course of COPD, helping to change the way patients live with their disease.2,3 It is the most prescribed medication for the treatment of COPD in the world.11 Spiriva® works through targeting of a dominant reversible mechanism of COPD – cholinergic bronchoconstriction. Spiriva® helps COPD patients breathe easier by opening narrowed airways and helping to keep them open for 24 hours. The Spiriva® clinical trials programme has recruited over 25,000 patients.12 Spiriva® has demonstrated significant and sustained bronchodilation (opening of the airways) 3,13 and reduction in hyperinflation (air trapping).14,15 Spiriva® also demonstrated superior and sustained improvements in lung function (FEV1) over ipratropium bromide (Atrovent®) Inhalation Aerosol, a current first-line therapy for COPD, which were maintained over one year3 and has also demonstrated superior improvement in key lung function parameters over salmeterol.16 In addition, in placebo-controlled studies, patients treated with Spiriva® had less activity-induced breathlessness and improved exercise endurance. They required fewer doses of rescue medications, had fewer exacerbations and COPD-related hospitalizations.13 In clinical trials, the most common adverse reaction reported with Spiriva® was dry mouth, which was usually mild and often resolved during treatment.3,13 Long-acting bronchodilators, including tiotropium, are a preferred maintenance therapy for COPD from stage II onwards according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) treatment guidelines.17 REFERENCES: 1. Johansson G, Lindberg A, Romberg K, et al. Bronchodilator efficacy of tiotropium (TIO) in patients with mild COPD. Poster presented at ERS, Tuesday 5 September 2006. 2. Casaburi R, Kukafka D, Cooper CB, et al. Improvement in exercise tolerance with the combination of tiotropium and pulmonary rehabilitation in patients with COPD. Chest 2005; 127:809-817. 3. Vincken W, van Noord JA, Greefhorst APM, et al. Improved health outcomes in patients with COPD during 1 year's treatment with tiotopium. Eur Respir J 2002; 19:209-216. 4. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease. Executive Summary. GOLD website (http://www.goldcopd.com). Updated 2005. 5. Halpin DM. Chronic obstruction lung disease. 2001. London: Mosby. 6. World Health Organization. World Health Report 2004. Statistical Annex. Annex table 2 and 3:120-131. 7. Murray CJL, Lopez AD. eds. The Global Burden of Disease: a comprehensive assessment of mortality and disability from diseases, injuries, and risk factors in 1990 and projected to 2020. Cambridge; Harvard University Press; 1996. 8. Halbert RJ, Natoli JL, Gano A, et al. Global burden of chronic obstructive pulmonary disease: systematic review and meta-analysis. Eur Respir J 2006; 28:1-10. 9. Centers for Disease Control and Prevention. Surveillance Summaries, August 2, 2002. MMWR: 51 (No SS06). http://www.cdc.gov/mmwr. 10. Rudolf M. The reality of drug use in COPD: The European Perspective. Chest 2000; 117(suppl): 29S-32S. 11. IMS Health, IMS MIDAS(tm), 2Q2005. 12. Boehringer Ingelheim. Data on file. 13. Casaburi R, Mahler DA, Jones PW, et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur Respir J. 2002; 1:217-224. 14. Celli B, ZuWallack R, Wang S, et al. Improvement in resting inspiratory capacity and hyperinflation with tiotropium in COPD patients with increased static lung volumes. Chest 2003; 124: 1743-1748. 15. O'Donnell DE, Fluge T, Gerken F, et al. Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD. Eur Respir J. 2004 23(6):832-48. 16. Brusasco V, Hodder R, Miravitlles M, et al. Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD. Thorax 2003; 58: 399-404. 17. Pocket Guide to COPD diagnosis, management, and prevention – A guide for healthcare professionals. Global Initiative for Chronic Obstructive Lung Disease. Available at: http://www.goldcopd.com. SOURCE: Boehringer Ingelheim GmbH

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