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®
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