Comparative efficacy and tolerability of beclomethasone/formoterol and fluticasone/salmeterol fixed combination in Taiwanese asthmatic patients
Journal
Journal of the Formosan Medical Association
Journal Volume
117
Journal Issue
12
Pages
1078-1085
Date Issued
2018
Author(s)
Hsieh M.-J.
Lin Y.-C.
Lai R.-S.
Wu C.-L.
Lai C.-L.
Wang C.-C.
Perng D.-W.
Kao S.-J.
Chang E.-T.
Perng W.-C.
Hsu J.-Y.
Lin C.-H.
Tsai Y.-H.
Abstract
Background: The study was designed to compare the efficacy and tolerability of a fixed combination of extra-fine beclomethasone and formoterol, with the fixed combination fluticasone and salmeterol in Taiwanese asthmatic patients. Methods: This was a phase III, multicentre, randomized, two-arm parallel groups, controlled study. Patients with moderate to severe asthma were randomized to a 12-week treatment with either beclomethasone 100 mcg plus formoterol 6 mcg (BDP/F) or fluticasone 125 mcg plus salmeterol 25 mcg (FP/S), both delivered 2 inhalations twice daily. The efficacy and tolerability of these two combinations were compared. Results: Among the 253 randomized subjects, 244 patients were evaluable (119 in the BDP/F group and 125 in the FP/S group). A significant improvement from baseline to the end of treatment period was observed in both BDP/F and FP/S groups in forced expiratory volume in the first second (FEV 1 ), forced vital capacity (FVC), morning and evening peak expiratory flow (PEF), Asthma Control Test (ACT) score and the use of rescue medication. FVC increase from pre-dose was significant after 5 min post inhalation in the BDP/F group only, while statistically significant within group improvement was not achieved until 30 min post inhalation in the FP/S group. Conclusion: The BDP/F combination is comparable in efficacy and tolerability to FP/S combination in Taiwanese asthmatic patients, with the advantage of rapid onset of improvement of FVC, consistent with the faster improvement of pulmonary hyperinflation with BDP/F. ? 2017
Subjects
Asthma; Combination therapy; Inhaled corticosteroid; Long acting beta2-agonist; Pulmonary hyperinflation
SDGs
Other Subjects
beclometasone; fluticasone; formoterol; salmeterol; beclometasone; fluticasone propionate plus salmeterol; formoterol fumarate; adult; aged; Article; asthma; Asthma Control Test; combination drug therapy; comparative study; controlled study; disease severity; double blind procedure; drug efficacy; drug safety; drug tolerability; female; forced expiratory volume; forced vital capacity; human; hyperinflation; intention to treat analysis; laboratory test; major clinical study; male; multicenter study; patient safety; peak expiratory flow; phase 3 clinical trial; randomized controlled trial; spirometry; Taiwanese; treatment duration; upper respiratory tract infection; asthma; clinical trial; inhalational drug administration; middle aged; severity of illness index; statistical model; Taiwan; Administration, Inhalation; Adult; Asthma; Beclomethasone; Double-Blind Method; Female; Fluticasone-Salmeterol Drug Combination; Forced Expiratory Volume; Formoterol Fumarate; Humans; Linear Models; Male; Middle Aged; Severity of Illness Index; Taiwan
Publisher
Elsevier B.V.
Type
journal article