SPIRIVA(R) Significantly Improves Lung Function in Patients With Mild COPD

SPIRIVA(R) Significantly Improves Lung Function in Patients With Mild COPD

September 05, 2006

- First Prospective Study to Investigate the Effect of SPIRIVA(R) in Early Stage COPD, an Under-Diagnosed Condition Affecting Overall one in ten Adults Globally

    MUNICH, Germany, Sept. 5 /Xinhua-PRNewswire/ --
Patients with mild(x) chronic obstructive pulmonary disease
(COPD) treated with SPIRIVA(R) (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(R) in this specific
subset of the wider COPD population.

    SPIRIVA(R), 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(R) 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(R)."

    The study was a 12-week, randomised, double-blind,
placebo-controlled trial of 224 patients with mild COPD.(x)
Results showed significant improvement in all lung function
assessments with SPIRIVA(R) 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(R) significantly improved FEV1 area under
the curve (AUC0-2h)
       by 8.4%, p<0.0001

    -- SPIRIVA(R) significantly improved trough FEV1 by 6%,
p<0.0001

    Improvements were apparent 30 minutes after the first
dose of SPIRIVA(R), 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."

    Notes to Editors

    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(R)

    SPIRIVA(R), 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(R) 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(R) works through targeting of a dominant
reversible mechanism of COPD - cholinergic
bronchoconstriction. SPIRIVA(R) helps COPD patients breathe
easier by opening narrowed airways and helping to keep them
open for 24 hours.

    The SPIRIVA(R) clinical trials programme has recruited
over 25,000 patients.(12) SPIRIVA(R) has demonstrated
significant and sustained bronchodilation (opening of the
airways) (3,13) and reduction in hyperinflation (air
trapping).(14,15) SPIRIVA(R) also demonstrated superior and
sustained improvements in lung function (FEV1) over
ipratropium bromide (ATROVENT(R)) Inhalation Aerosol, a
current first-line therapy for COPD, which were maintained
over one year(3) and has also demonstrated superior
improvement in key lung function parameters over
salmeterol.(16) In addition, in placebo-controlled studies,
patients treated with SPIRIVA(R) 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(R) 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)

    About Boehringer Ingelheim

    The Boehringer Ingelheim group is one of the world's 20
leading pharmaceutical companies. Headquartered in
Ingelheim, Germany, it operates globally with 143
affiliates in 47 countries and almost 37,500 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 2005, Boehringer Ingelheim posted net sales of 9.5
billion euro while spending almost one fifth of net sales
in its largest business segment Prescription Medicines on
research and development.

    For more information please visit
http://www.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
http://www.pfizer.com

    Graphics, photos and data for feature articles are
available on request.

    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

    (x) Patients had mild COPD according to Swedish COPD
treatment
        guidelines: FEV1/FVC <70%, post bronchodilator
FEV1 greater than or 
        equal to 60% predicted and Medical Research Council
(MRC) symptom     
        scores greater than or equal to 2

    For more information, please contact:

     Judith von Gordon
     Corporate Division Communications
     Boehringer Ingelheim GmbH GERMANY
     Tel:   [phone]

     Francisco Gebauer
     Corporate Media Relations 
     Pfizer Inc, USA
     Tel:   [phone]

SOURCE  Boehringer Ingelheim GmbH; Pfizer Inc