SYMBICORT(R) Added To Tiotropium Provided Clinically Significant Benefits For Patients With Severe COPD

Main Category: COPD
Also Included In: Respiratory / Asthma
Article Date: 25 May 2009 - 3:00 PDT

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Data presented at this year's American Thoracic Society (ATS) congress, demonstrated that SYMBICORT® (budesonide/formoterol-TURBUHALER®, a dry powder inhaler) added to SpirivaTM (tiotropium) provided greater clinical improvements than tiotropium alone over a 12-week treatment period.1,2

Results of the CLIMB study showed that the occurrence of severe exacerbations was reduced by as much as 62 percent in patients where budesonide/formoterol was added to tiotropium (p<0.001) compared to tiotropium used alone.2

In addition, CLIMB showed that patients treated with SYMBICORT (budesonide/formoterol) in combination with tiotropium experienced greater relief from morning breathlessness, improved ability to carry out morning activities and, a reduced need for relief medication.1 The benefits were evident after just one week of treatment and importantly further improved over the treatment period.1

Professor Tobias Welte, Lead Investigator in the CLIMB study commented, "These important findings demonstrate the value to COPD patients in adding budesonide/formoterol to tiotropium. Patients experienced greater and more rapid control of their symptoms, which improved over the treatment period. We know COPD limits simple, everyday activities and is especially troublesome for patients in the mornings, when they are trying to carry out activities such as washing and dressing."

Most COPD patients indicate morning as the time that their symptoms are most severe, with morning symptoms being most pronounced in patients with severe COPD. Partridge et al3 concluded that 82 percent of severe COPD patients considered the impact of COPD in the morning to be a problem, with nearly 60 percent of severe patients experiencing shortness of breath immediately after waking every day or on most days.3 These findings clearly indicate that COPD has a high impact on morning routines making everyday activities such as getting dressed, putting on socks and shoes and walking up and down stairs difficult.

In an additional study presented at ATS, CODEX data demonstrated that COPD patients treated with SYMBICORT (budesonide/formoterol), experienced higher exercise capacity shortly after taking SYMBICORT (budesonide/formoterol) in the morning.4 Just one hour after taking the morning dose, COPD patients treated with budesonide/formoterol benefited from rapid and clinically relevant improvements in exercise tolerance compared with placebo and formoterol independently. These benefits were also seen 6 hours after the morning dose.3

Professor Martyn Partridge, Professor of Respiratory Medicine at Imperial College London, added, "We know morning to be the time of day when patients often experience their most severe COPD symptoms. As a result of this, many patients experience challenges with simple morning routines such as getting dressed or going up and down the stairs. Doctors need to routinely ask patients about the time of day when patients' symptoms are worse and wherever possible adjust therapy to cover this time and encourage the use of medication on awaking."

SYMBICORT is formulated in a TURBUHALER, a dry powder inhaler, and in the U.S. in a pressurized metered dose inhaler (pMDI).

References

1. Welte T, Miravitlles M, Peterson S et al. Budesonide/formoterol added to tiotropium improves the management of COPD patients. Abstract presented at American Thoracic Society (ATS) International Conference, San Diego, USA. May 15-20 2009

2. Welte T, Hartman L, Polanowski T et al. Budesonide/formoterol added to tiotropium is well tolerated and reduces risk of severe exacerbations in COPD patients. Abstract presented at American Thoracic Society (ATS) International Conference, San Diego, USA. May 15-20 2009

3. Partridge M, Karlsson N and Small I. Patient insights into the impact of COPD on morning symptoms, activities and daily life. Abstract presented at BTS 2008

4. Worth H, Peterson S, Nihlén U et al. Improved exercise tolerance with budesonide/formoterol vs placebo and formoterol in COPD patients. Abstract presented at American Thoracic Society (ATS) International Conference, San Diego, USA. May 15-20 2009

SYMBICORT, SYMBICORT SMART AND TURBUHALER are trademarks of the AstraZeneca group of companies

-SYMBICORT is a combination of two proven medications - the inhaled corticosteroid (ICS), budesonide (Pulmicort®), and the fast-acting and long-acting bronchodilator (LABA), formoterol (Oxis®) in one inhaler

- SYMBICORT is a rapid-acting combination therapy indicated for the long-term maintenance treatment of asthma, SYMBICORT SMART (Maintenance And Reliever Therapy), as well as Chronic Obstructive Pulmonary Disease (COPD), are all delivered via the SYMBICORT Turbuhaler device. SYMBICORT SMART and SYMBICORT Turbuhaler are not available in the U.S.

Source
AstraZeneca