COPD Indication
Symbicort®, which contains the anti-inflammatory corticosteroid budesonide and the rapid and long-lasting bronchodilator formoterol together in a single dry powder inhaler (Turbuhaler®), is indicated for both the treatment of COPD and asthma. There is more information about Symbicort for COPD treatment elsewhere on this site. In COPD, Symbicort is used as a maintenance treatment for patients with severe disease (a forced expiratory volume in 1 second [FEV1] < 50% predicted normal, and a history of repeated exacerbations) who cannot be controlled using long-acting bronchodilators alone, in accordance with the recommendations of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy [1].
SEE YOUR LOCAL COUNTRY SYMBICORT PRODUCT INFORMATION, AS PRESCRIBING INFORMATION MAY VARY FROM COUNTRY TO COUNTRY.
Symbicort® Dosage
The approved Symbicort dosage for the treatment of COPD is: Symbicort Turbuhaler, 320/9 μg/inhalation and 160/4.5 μg/inhalation.
Symbicort® – Efficacy in COPD
What recent studies have demonstrated the effectiveness of Symbicort® in COPD?
Two 12-month clinical trials [2,3] showed that Symbicort, when used at the approved Symbicort dose significantly reduces the risk of exacerbations requiring medical intervention and provides rapid and sustained improvement in lung function (FEV1 and morning peak expiratory flow [PEF]) and symptom relief compared with monotherapies and placebo. Find out more about the Calverley study on short-term improvements in COPD and the Szafranski study on the safety and efficacy of Symbicort in COPD.
A more recent 3-month study by Welte et al. [4] (The CLIMB study) has further shown that when Symbicort is added to the anticholinergic drug tiotropium, there are greater improvements in lung function, symptoms and patients ability to perform morning activities as well as a greater reduction in COPD exacerbations compared with tiotropium alone.
Does Symbicort® improve COPD symptoms?
Symbicort provides sustained relief from the symptoms of COPD. Symbicort has been shown to significantly reduce all symptom scores (total symptom score, night-time awakenings, breathlessness, cough and chest tightness) within the first week of treatment versus budesonide alone, formoterol alone and placebo [3]. The Szafranski study demonstrated that this effect was sustained for 12 months with Symbicort versus placebo and budesonide alone and compared with formoterol: improvements in night-time awakenings were maintained throughout the treatment period. In the CLIMB study, symptom scores were also significantly improved with Symbicort added to tiotropium versus tiotropium alone and patients were reported to be less breathless within 5 minutes of receiving the treatment [4].
Does Symbicort® improve morning symptoms and activities?
Evidence suggests that morning is the time when symptoms are most severe and patients’ abilities to perform regular morning activities the most problematic [5]. Importantly, in the CLIMB study, Symbicort added to tiotropium has been shown to significantly improve morning symptom scores including morning breathlessness and reliever use and improves patients’ abilities to perform morning activities, such as walking up and down the stairs, putting on shoes and socks, making the bed and dressing, compared with tiotropium alone [4]. These measures were assessed using two simple, validated patient-administered questionnaires, developed by AstraZeneca – 1) the Global Chest Symptoms Questionnaire (GCSQ), to evaluate morning symptoms and 2) the Capacity of Daily Living in the Morning questionnaire (CDLM), to evaluate patients’ ability to perform morning activities [6]. Both questionnaires can be self-administered at home and form a simple instrument to assess the impact of treatment on the most burdensome time of day for COPD patients.
To what extent does Symbicort® reduce exacerbations?
Symbicort has been reported to extend the time to first severe exacerbation by 158 days more than placebo, 100 days more than formoterol alone, and 76 days more than budesonide alone [2]. In the Calverley study, Symbicort also reduced the risk of having a COPD exacerbation by 29% versus placebo, 30% versus formoterol and 23% versus budesonide.
Moreover, a significant 62% reduction in the rate of severe exacerbations and a 65% reduction in the rate of hospitalisations/emergency room treatments has been reported (in the CLIMB study) with Symbicort added to tiotropium versus tiotropium alone [4].
These reductions in COPD exacerbations provide a significant improvement in COPD patients’ quality of life, and help to give patients the confidence to return to, and perform, daily and morning activities.
Does Symbicort® improve quality of life?
The health-related quality of life of patients with COPD can be measured using the St George’s Respiratory Questionnaire (SGRQ), which measures the impact of the disease on well-being and daily life, and has been validated for use in patients with COPD [7]. A four-point reduction in score is considered a clinically relevant improvement, noticeable by the patient. A worse quality of life predicts a worse clinical outcome [8].
Symbicort has been shown to provide a meaningful improvement in patients’ health-related quality of life [2]. Symbicort provided a sustained reduction of 7.5 in the SGRQ score compared with placebo. This was a superior improvement to that seen with formoterol alone (reduction of 4.1 versus placebo) and budesonide alone (reduction of 3.0 versus placebo). In the Calverley study, Symbicort also showed a significant improvement in SGRQ score as compared with budesonide and formoterol alone by 4.1 and 3.4 points respectively].
Symbicort improves health related quality of life (SGRQ total score) [2]
Does Symbicort® improve lung function?
Symbicort provides a rapid and sustained improvement in lung function [2-4]. Calverley et al, showed that Symbicort maintained improvements in post-dose FEV1 in the 12 months following treatment intensification with prednisolone and inhaled formoterol [2]. In contrast, the FEV1 declined after this treatment intensification period with all other treatments (budesonide alone, formoterol alone and placebo).
Symbicort improves FEV1 [2]
Symbicort also improved and maintained morning PEF compared with budesonide alone, formoterol alone and placebo [3].
Symbicort improves morning PEF in COPD [3]
The CLIMB study also reported significant improvements in lung function with Symbicort added to tiotropium compared with tiotropium alone, both at the clinic and at the bedside soon after arising from bed [4].
For more information, see:
References
- # Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2009. Available at: http://goldcopd.org/Guidelineitem.asp?l1=2&l2=1&intId=2003. Accessed December 9, 2009.
- Calverley PM, Boonsawat W, Cseke Z, et al. Maintenance therapy with budesonide and formoterol in chronic obstructive pulmonary disease. Eur Respir J 2003;22:912-919.
- Szafranski W, Cukier A, Ramirez A, et al. Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease. Eur Respir J 2003;21:74-81.
- Welte T, Miravitlles M, Peterson S, et al. Budesonide/formoterol added to tiotropium improves the management of COPD patients. Am J Resp Crit Care Med 2009;180:741-750.
- Partridge MR, Karlsson N, Small IR. Patient insight into the impact of chronic obstructive pulmonary disease in the morning: an internet survey. Curr Med Res Opin 2009;25:2043-2048.
- Partridge MR, Miravitlles M, Ståhl E, et al. Development and validation of the Capacity of Daily Living during the Morning questionnaire and Global Chest Symptoms Questionnaire for patients with COPD. Eur Respir J 2009;Published online 6 November 2009; doi:10.1183/09031936.00123709.
- Jones PW. Interpreting thresholds for a clinically significant change in health status in asthma and COPD. Eur Respir J 2002;19:398-404.
- Osman IM, Godden DJ, Friend JA, et al. Quality of life and hospital re-admission in patients with chronic obstructive pulmonary disease. Thorax 1997;52:67-71.
