Budesonide/Formoterol Plus Tiotropium Improves the Quality of Life of Patients With Severe COPD

LUTON, England - 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

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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

Source: AstraZeneca

For further information please contact: Suzie Collett, Respiratory Communications Manager, AstraZeneca: +44(0)1582-836653, Suzie.Collet at astrazeneca.com; Emma Grundlingh, Brand(x) Communications: +44(0)208-987-6700, Emma.Grundlingh at brandxcoms.com