The purpose of the present study is to demonstrate the higher efficacy of small particles Foster® 100/6 (two puffs b.i.d.) versus large particles Symbicort® 200/6 (two inhalations b.i.d.), in terms of residual volume reduction over a 12-week treatment period in Chronic Obstructive Pulmonary Disease (COPD) patients.
Chronic obstructive pulmonary disease (COPD) is an incurable, debilitating and progressive disease that can be fatal. The recent Global Burden of Disease Study ranks COPD as the 6th leading cause of mortality and the 12th leading cause of morbidity world-wide. Furthermore, trends in the use of medical care resources indicate that the economic cost of COPD continues to rise in direct relation to the ageing population, the increase in prevalence of disease and the cost of new and existing medical and public health interventions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
113
Foster® (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose), 2 inhalations b.i.d. (daily dose of BDP "extrafine" 400 µg plus FF 24 µg).
Symbicort® Turbohaler® (budesonide 200 μg plus formoterol fumarate 6 μg/actuation), 2 inhalations b.i.d. (daily dose of BUD 800 μg plus FF 24 μg).
Department of Pulmonary Diseases - University Medical Center Groningen
Groningen, Netherlands
Change from baseline to end of treatment in post-dose residual volume.
Time frame: At day 84
Changes from baseline in FEV1, FVC, FEV1/FVC, IVC/FVC, RV, TLC, RV/TLC, FRC, FRC/TLC, RV/VC, Raw, eff and sGaw, eff.
Time frame: At day 84
Changes from baseline in airways resistance (R5, R20, R5-20) and reactance at 5 Hertz (X5) (in a subset of at least 50% of patients from pre-selected sites);
Time frame: at day 84
Changes from baseline in COPD symptom scores (for each single score and the total score);
Time frame: At day 84
Change from baseline in percentage of COPD symptom-free days;
Time frame: At day 84
Change from baseline in rescue salbutamol or ipratropium bromide consumption (puffs per day);
Time frame: At day 84
Change from baseline in percentage of rescue salbutamol or ipratropium bromide-free days;
Time frame: At day 84
Transition Dyspnoea Index (TDI) score;
Time frame: At day 84 (V4)
Clinical COPD Questionnaire (CCQ);
Time frame: At screening (day -28), at baseline (day 0) and at the end of trial (day 84)
Physical activity (by means of pedometer);
Time frame: Each day of the two weeks before each clinic visit
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Nasal brushing (mRNA expression);
Time frame: At screening (day -28), at baseline (day 0) and at the end of trial (day 84)
Number of patients with COPD exacerbations.
Time frame: From pre-screening (day -35) to the end of trial (day 84)