Table. 4—

Studies performed with an extra-fine fixed combination hydrofluoroalkane-beclomethasone dipropionate (HFA-BDP)/formoterol pressurised metered-dose inhaler

Asthma patientsFirst author [ref.]ProtocolPrimary outcomeSecondary outcomes
Moderate to severe uncontrolled with ICSPapi [159]HFA-BDP/formoterol 200/12 μg b.i.d.; n = 109 BUD/formoterol 400/12 μg b.i.d.; n = 110 12 weeksMorning peak flowFEV1 FVC FEF50% Exacerbations Symptoms
Papi [160]HFA-BDP/formoterol 200/12 μg b.i.d.; n = 115 FP/salmeterol 250/50 μg b.i.d.; n = 113 12 weeksMorning peak flowFEV1 FVC Exacerbations Symptoms
Moderate to severe stable with ICS+LABAHuchon [161]HFA-BDP/formoterol 200/12 μg b.i.d.; n = 211 Free association: CFC-BDP 1000 μg per day + formoterol DPI 24 μg per day; n = 220 CFC-BDP 1000 μg per day; n = 212Morning peak flowFEV1 Exacerbations Symptoms
  • ICS: inhaled corticosteroids; LABA: long-acting β-agonist; BUD: budesonide; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; FEF50%: forced expiratory flow at 50% of FVC; FP: fluticasone propionate; DPI: dry powder inhaler.