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Press Release
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New data show SPIRIVA® HandiHaler® reduced hyperinflation in the lungs and improved exercise tolerance in patients with COPD
ORLANDO, Florida, May 26, 2004 - Tiotropium bromide inhalation powder (SPIRIVA® HandiHaler®) reduced lung hyperinflation and improved exercise tolerance in patients with Chronic Obstructive Pulmonary Disease (COPD), according to the results of a clinical study presented today at the 100th international conference of the American Thoracic Society.1,2 SPIRIVA HandiHaler was recently approved by the FDA for the long-term, once-daily, maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema.3
Patients with COPD have chronic expiratory airflow limitation which means that it takes longer to exhale air from their lungs compared to healthy people. As a result, patients with COPD develop hyperinflation characterized by the inability to fully exhale leading to air being trapped in the lungs. Hyperinflation, sometimes referred to as chronic air trapping, has been associated with dyspnea or the subjective sensation of breathlessness.4 Dyspnea with exertion is a common symptom of COPD. Dyspnea limits a patient's ability to perform physical activities. Patients at all stages of disease benefit from exercise training programs with improvements in exercise tolerance, and symptoms of breathlessness and fatigue.7 The effect of an intervention on exercise tolerance can be measured in the laboratory using constant work rate exercise testing.
A six week, randomized, double-blind, placebo-controlled study was conducted to evaluate the effect of treatment with tiotropium on exercise tolerance in 261 patients with COPD. Lung volumes and airflow were evaluated as secondary outcome measures in the multicenter, multinational study. During the screening period, maximal work capacity was determined from incremental exercise testing using a stationary bicycle. Patients then performed constant work rate exercise testing at 75% of maximal work capacity until they were unable to continue due to symptoms. This was done at baseline, and 2.25 and 8 hours after the first dose of study medication on the first day of treatment (day 0) and after 3 and 6 weeks of treatment. Patients rated dyspnea intensity using a dyspnea rating scale (Borg), prior to exercise, every 2 minutes during exercise and at symptom limitation. Patients in both groups were allowed to continue using previously prescribed respiratory medications, including rescue albuterol, theophyllines, and inhaled and oral corticosteroids throughout the 6 week treatment period.
Treatment with tiotropium showed statistically significant increases in exercise tolerance time compared to placebo. At the end of the study, patients in the tiotropium group were able to exercise a mean of 164 seconds longer (28.4%) compared to patients in the placebo group (p<0.01) at 2.25 hours after administration of study medication. Improved exercise tolerance was sustained 8 hours post-dose, at which time tiotropium-treated patients demonstrated a mean improvement in exercise duration of 106 seconds (21.0%) greater than placebo (p<0.02). Lung hyperinflation also showed a statistically significant reduction at rest and after exercise in the tiotropium group. This was manifested by an improvement in inspiratory lung capacity compared to placebo during exercise challenge, 2.25 hours post-dose (mean: 1.92 Liter vs 1.78 Liter; p<0.01) and 8 hours post-dose (mean: 1.86 Liter vs 1.73 Liter; p<0.01).
"Hyperinflation is a key target for COPD therapy as it is associated with chronic shortness of breath which gets worse during activity," said principal investigator Denis O'Donnell, MD, head of the Division of Respiratory and Critical Care Medicine, Queen's University, Canada. "It is therefore important to target hyperinflation to help manage the impact of this disease."
Results of the clinical study showed tiotropium improved symptom-limited exercise tolerance and reduced hyperinflation at rest and during exercise. These improvements were present for at least eight hours post-dose after six weeks of treatment.
About Chronic Obstructive Pulmonary Disease
COPD is a slowly progressive disease of the airways that is characterized by an accelerated loss of lung function over time.5 The signs and symptoms that patients may experience are chronic cough, excess mucus production, wheezing and shortness of breath even after mild exertion. COPD is primarily caused by smoking.5 There are an estimated 24 million US adults who suffer from COPD, but only 10 million have been diagnosed. Globally, this disabling disease is the fourth leading cause of death claiming 2.74 million lives annually.6
About Tiotropium Bromide Inhalation Powder
Tiotropium is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Tiotropium is not indicated for rescue therapy and is contraindicated in patients with a history of hypersensitivity to atropine or its derivates or to any component of this product. The most common adverse reaction was dry mouth, which was usually mild and often resolved during treatment.3
Notes
*Lung volume/capacity definitions:
- Residual lung volume: volume of air remaining in the lung at the end of a maximal exhalation
- Functional residual lung capacity: volume of air remaining in the lung at the end of a normal exhalation
- Inspiratory lung capacity: maximum volume of air that can be inhaled after normal exhalation
About Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 152 affiliates in 45 countries and more than 34,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2003, Boehringer Ingelheim posted net sales of US $8.37 billion (7.4 billion euro) while spending more than one fifth of net sales in its largest business segment, Prescription Medicines, on research and development.
For more information, please visit http://us.boehringer-ingelheim.com
About Pfizer Inc
Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines for humans and animals, and many of the world's best-known consumer products.
For further information on Pfizer, please see www.pfizer.com
Contacts
Boehringer Ingelheim (US)
Lara Crissey
Boehringer Ingelheim Pharmaceuticals, Inc.
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Ridgefield, CT 06877
Phone: (203) 798-4740
Fax: (203) 791-6442
Pfizer Inc.
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Corporate Media Relations
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USA
Phone: +1/212 733-4554
References
- O'Donnell D, Marciniuk D, Hernandez P et al. SPIRIVA® (tiotropium) reduces lung hyperinflation at rest and during exercise in COPD patients. Abstract presented at ATS 2004, Orlando, Florida. 21-26 May 2004.
- O'Donnell D, Maltais F, Sciurba F et al. SPIRIVA® (tiotropium) improves symptom-limited exercise tolerance in COPD patients. Abstract presented at ATS 2004, Orlando, Florida. 21-26 May 2004.
- Spiriva® HandiHaler® (tiotropium bromide inhalation powder) Prescribing Information; Boehringer Ingelheim and Pfizer Inc 2004. Available at www.spiriva.com
- O'Donnell DE, Revill SM, Webb KA. Am J Respir Crit Care Med 2001;164(5): 770-777.
- National Institutes of Health. National Heart, Lung, and Blood Institute. Morbidity and Mortality: 2002 Chart Book on Cardiovascular, Lung, and Blood Diseases. May 2002.
- World Health Organization. World health report 2003. Statistical Annex. Annex table 2: 154-159.
- Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease. NHLBI/WHO workshop report. Bethesda, National Heart, Lung and Blood Institute, April 2001; Update of the Management Sections, GOLD website (http://www.goldcopd.com). Date updated: July 2003.