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®
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.