Symbicort® COPD (budesonide/formoterol)

Symbicort® (budesonide/formoterol) Turbohaler® and Symbicort® pMDI are combinations of an inhaled corticosteroid and a long-acting β2-agonist 

Chronic obstructive pulmonary disease (COPD) and Symbicort®

Exacerbation reduction

Symbicort® Turbohaler® reduced the incidence of severe exacerbations* by 23% vs formoterol4

 

 

This study demonstrated that Symbicort® Turbohaler® increased FEV1 (co-primary endpoint) by 1% vs formoterol (n=208 and n=201 respectively; p=NS) and demonstrated a reduction in severe exacerbations* with Symbicort® Turbohaler® 200/6 μg vs formoterol 6 μg: 1.42 vs 1.84 severe exacerbations* per patient per year, respectively.4


This was a 12-month, randomised, double-blind, placebo-controlled, parallel-group study in 812 adults (mean age 64 years, mean FEV1 36% predicted normal). Patients received 2 inhalations twice daily of either: Symbicort®Turbohaler® 200/6µg (n=208); budesonide 200 µg (n=198); formoterol 6µg (n=201); or placebo (n=205). Primary efficacy variables: number of severe exacerbations* and FEV1.4


*Severe exacerbations were defined as the use of oral steroids and/or antibiotics and/or hospitalisations due to respiratory symptoms.4

Doses are expressed as metered doses.

Symptom control

Change in lung function and morning activities: Symbicort Turbohaler vs salmeterol/fluticasone from baseline

The primary outcome of increase in morning PEF at 5mins post dose was similar (mean difference 1.0l/min, p=0.603) between Symbicort® 400/12 µg bd vs salmeterol/fluticasone 50/500 µg bd.

The increase in morning FEV1 at 15 mins was higher for Symbicort Turbohaler compared to salmeterol/fluticasone (0.14L vs 0.10L, p<0.05).

A secondary outcome variable showed relative improvement in total mean CDLM* score with Symbicort® Turbohaler® 400/12 μg twice daily vs salmeterol/fluticasone 50/500 μg twice daily (0.22 vs 0.12 respectively; 95% CI 0.01–0.19, p<0.05) when measured from baseline.5

Mean difference (0.10 [95% CI, 0.01-0.19; p<0.05]). A change of 0.2 units of CDLM represents the minimal important difference. The GCSQ** score secondary outcome variable showed no significant difference in treatment arms.5

 

This was a randomised, double-blind, multicentre, cross-over study in 442 patients with COPD aged ≥40 years (pre-bronchodilator FEV1 ≤50%; FEV1/vital capacity <70%) who received one inhalation of Symbicort® Turbohaler® 400/12 μg twice daily metered dose or one inhalation of salmeterol/fluticasone 50/500 μg twice daily metered dose for one week each. The primary endpoint was PEF 5 minutes post-morning dose, which was measured as the mean improvement from baseline over the full study period separated by a 1–2 week washout. Lung function variables (PEF + FEV1) shortly after rising from bed in the morning, symptoms, and basic morning activities vs baseline/washout were assessed using electronic diary recordings.5

*CDLM = Capacity of Daily living the during the Morning. CDLM was a questionnaire consisting of 6 questions, each item scored on a scale ranging from zero (so difficult that the activity could not be carried out by the patient themselves) to five (activity not at all difficult to carry out)5,6.

**GCSQ = Global Chest Symptoms Questionnaire.5

Doses are expressed as metered dose.

Device choice in COPD

Symbicort offers device choice for your COPD patients with Turbohaler and pMDI*

*Symbicort pMDI is to be used in the treatment of COPD and is not approved within the EU for the treatment of asthma. Symbicort® pMDI is not to be used as a reliever medication, andconsequently is not suitable for use as maintenance and reliever therapy (i.e. SMART).

**Particles in the aerodynamic size range from 1.5–5 μm are shown to be optimal, as particles <1.0 μm are very likely to be exhaled again while those >5 μm may impact on the oropharynx and be swallowed, potentially contributing to a reduction in efficacy and local oropharyngeal or systemic effects.9 Symbicort® metered dose particle size data are taken from in vitro studies.9,10 Symbicort® metered dose mass median aerodynamic diameter (MMAD) = 2.07 μm.10

Tolerability

Symbicort® tolerability profile1-3

Since Symbicort® contains both budesonide and formoterol, the same pattern of undesirable effects reported for these substances may occur.1-3

The most common drug-related adverse events are pharmacologically predictable side effects of β2-adrenoceptor agonist therapy, such as tremor and palpitations; these tend to be mild and usually disappear within a few days of treatment.1-3


An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids.1-3

*Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100). Only very common, common and uncommon side effects are presented. Please refer to the relevant SmPC for the full list of adverse events.1-3

**Only applies to Symbicort® 200/6 and 400/12.1,2

Summary of efficacy and device choice

Considering Symbicort®? you can now prescribe Symbicort Turbohaler or pMDI for your COPD patients who have a history of exacerbations.1-3

Symbicort Turbohaler 100/6 is not licensed in COPD
*Turbohaler (200/6µg and 400/12µg)
**Severe exacerbations were defined as the use of oral steroids and/or antibiotics and/or hospitalisations due to respiratory symptoms.

 

Case study

Patient Profile