Budesonide/Formoterol Plus Tiotropium Improves ...

LUTON, England, May 21 /PRNewswire/ --

- News Release for the Medical Media

    Preliminary results from a double-blind, randomised,
multicentre trial among 660 patients with chronic obstructive pulmonary
disease (COPD) show that budesonide/formoterol (Symbicort(R): AstraZeneca)
plus tiotropium (Spiriva(TM): Boehringer Ingelheim Limited) significantly
improves disease control and patients' quality of life (1,2).



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    The study known as CLIMB, compared 12 weeks treatment with
budesonide/formoterol (400/12 mcg one inhalation twice-daily) plus tiotropium
(18 micro g one inhalation once daily) vs. tiotropium alone plus placebo.



    "Combined inhaled corticosteroid (ICS) and long-acting
beta-agonist (LABA) therapy with budesonide/formoterol (Symbicort(R)) is
indicated for COPD patients with a forced expiratory volume in 1 second
(FEV1) < 50% predicted normal and a history of repeated exacerbations,"(3)
explained Professor Tobias Welte, the international coordinating investigator
of the CLIMB study. "While budesonide/formoterol combination is commonly used
together with tiotropium for the management of patients with severe COPD,
CLIMB is the first study to evaluate the therapeutic effect of combining
budesonide/formoterol with tiotropium. The results of the study confirmed
that this triple therapy regimen has a key role to play in the management of
patients with COPD," he continued.



    CLIMB showed that tiotropium plus budesonide/formoterol
combination versus tiotropium alone:



    
    - reduced the rate of severe exacerbations by 62% (p<0.001)(2)
    - improved clinical lung function as measured by improvement in pre
      and post dose FEV1 (p<0.001, FEV1 post-dose)(1)
    - improved morning symptoms and activities (p<0.05)(1)
    - Improved health-related quality of life as measured by SGRQ(1)
    - was well tolerated(2)





    "The CLIMB study findings are of considerable clinical
significance and come at a crucial time in light of the impending 2009
National Strategy to improve the care of COPD patients," said Professor Peter
Barnes, Professor of Thoracic Medicine and Head of Airway Disease at the
National Heart and Lung Institute. "Lung function deteriorates progressively
in patients with COPD, and the increasing number of exacerbations they
experience has a considerable impact on daily activities and Health-Related
Quality of Life (HRQL)."(5)



    Results of the recent 'Unleash the Life Survey' of 326 COPD
patients indicate that the impact of the disease on aspects of daily life are
of greatest concern to patients (6). Symptom control, however, appears to be 
of greater importance to healthcare professionals (6).



    "Importantly, CLIMB shows that budesonide/formoterol plus
tiotropium significantly improves patients' morning lung function and morning
activities such as getting washed and dressed, eating breakfast, and walking
around the home, as well as significantly reducing the rate of severe
exacerbations. Moreover, improvements in morning activities were evident
after only 1 week of treatment and were sustained over the entire treatment
period," continued Professor Tobias Welte.



    Full results of the CLIMB study are due to be published later
in 2009.



Notes to Editors

    An estimated 3.7 million people in the UK have COPD; COPD is
the 5th biggest killer in the UK; around 30,000 people in the UK die from
COPD each year, which is more than from bowel cancer, breast cancer or
prostate cancer (6).



About AstraZeneca

    AstraZeneca is a major international healthcare business
engaged in the research, development, manufacturing and marketing of
meaningful prescription medicines and supplier for healthcare services.
AstraZeneca is one of the world's leading pharmaceutical companies with
healthcare sales of US $ 31.6 billion and is a leader in gastrointestinal,
cardiovascular, neuroscience, respiratory, oncology and infectious disease
medicines. For more information about AstraZeneca, please visit:
http://www.astrazeneca.com



References

    1. Welte T, et al. Budesonide/formoterol added to tiotropium
improves the management of COPD patients. American Thoracic Society
International Conference, San Diego, USA, 15-20 May 2009; Abst 953775.



    2. Welte T, et al. Budesonide/formoterol added to tiotropium
is well tolerated and reduces the risk of severe exacerbations in COPD
patients. American Thoracic Society International Conference, San Diego, USA,
15-20 May 2009; Abst 953763.



3. Symbicort 400/12(R) Summary of Product Characteristics, December 2008.

    4. Miravitlles M et al. Patient's perception of exacerbations
of COPD - The PERCEIVE study. Respir Med 2007; 101: 453-60.



    5. 'Unleash the life within...' a patient's perspective of
living with Chronic Obstructive Pulmonary Disease (COPD) Survey. Sponsored by
AstraZeneca UK Ltd.



    6. British Lung Foundation. Invisible Lives. Chronic
Obstructive Pulmonary Disease (COPD) - finding the missing millions, November
2007.



CZ001156-SYMB; May 2009