Symbicort® COPD (budesonide/formoterol)

Symbicort® 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 formoterol (1.42 vs 1.84 mean exacerbation per patient per year).4

Szafranski study4: this was a 12-month, randomised, double-blind, placebo-controlled, parallel-group study in 812 adult COPD patients (mean age 64 years, mean FEV1 36% predicted normal).  Patients received 2 inhalations twice daily of either:  Symbicort® Turbohaler® 200/6 (n=208); budesonide 200 µg (n=198); formoterol 6 µg (n=201); or placebo (n=205).

Co-primary efficacy variables were:

  1. Number of severe exacerbations.*  Symbicort Turbohaler 200/6 significantly reduced the mean severe exacerbation rate per person per year versus placebo and formoterol and non-significantly versus budesonide.
  2. FEV1. During the 12-month study period all active treatments significantly increased FEV1 versus placebo.  Symbicort 200/6 also increased FEV1 versus budesonide but not versus formoterol.

Symbicort Turbohaler reduced the incidence of severe exacerbations by 24% versus placebo (1.42 vs. 1.87 per patient per year respectively (p=0.035))

Symbicort Turbohaler reduced the incidence of severe exacerbations by 11% versus budesonide (1.42 vs. 1.59 per patient per year respectively (p=0.385)).


*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.

COPD = Chronic Obstructive Pulmonary Disease: FEV1 = Forced expiratory volume in 1 second

Symptom control / Morning activity

Partridge study5: 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 twice daily or one inhalation of salmeterol/fluticasone propionate 50/500 twice daily for one week each separated by a 1 to 2 week washout period.

Primary end point was PEF 5 minutes post-morning dose, which was measured as the mean improvement from the baseline/wash-out period to the mean over the 1-week treatment period.

The primary outcome of increase in morning PEF at 5 minutes post dose was similar in both study arms: estimated increase from baseline was 15.1 l/min for Symbicort Turbohaler and 14.2 l/min for salmeterol/fluticasone treatment (mean difference 1.0L/min, p-0.603).

Symptom control (secondary end points) included lung function variables (PEF and FEV1) shortly after rising from bed in the morning.

Mean morning FEV1, measured at home over the full study period, improved more following Symbicort Turbohaler 400/12 treatment versus salmeterol/fluticasone 50/500 at 5 minutes (0.12 l versus 0.09 l; p=0.090) and 15 minutes (0.14 l versus 0.10 l; p<0.05) post-dose.  Symbicort Turbohaler 400/12 demonstrated a more rapid onset of effect vs salmeterol/fluticasone 50/500 as reflected by increases in e-Diary-recorded PEF and FEV1 from pre-dose to 5 and 15 minutes post-dose (all p<0.001) and spirometry at the clinic measured after the first dose (FEV1 p<0.001; 5 minutes post-dose).

Morning activities (a secondary end point) such as getting bathed, dried, dressed, eating breakfast and walking around the house were assessed using the Capacity of Daily Living during the Morning (CDLM) questionnaire¥ which was assessed after all morning activities were completed.  Responses were recorded using electronic diary recordings.5

*Mean difference between Symbicort Turbohaler 400/12 and salmeterol/fluticasone propionate 50/500 was 0.10 (95% CI 0.01-0.19: p<0.05).  A change of 0.2 units in CDLM score represents the minimal important difference.

‡ Doses are expressed as metered dose.

¥ The CDLM questionnaire consists of six questions.  Each item is 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).

CDLM = Capacity of Daily Living during the Morning: COPD = Chronic Obstructive Pulmonary Disease:  FEV1 = Forced expiratory volume in 1 second:  PEF = Peak expiratory flow

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, and consequently 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.7 Symbicort® metered dose particle size data are taken from in vitro studies.7, 8 Symbicort® metered dose mass median aerodynamic diameter (MMAD) = 2.07 μm.8

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

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