Table. 2—

Clinical outcomes

VariableSAL/FLU + salbutamolBUD/FORM maintenance + as neededp-value
Patients n10761067
All severe exacerbations
 Patients with event n (%)204 (19)159 (15)0.0076#
 Rate events·patient−1·yr−10.310.240.0025
Severe exacerbations excluding unscheduled clinic visits
 Patients with event n (%)167 (16)132 (12)0.025#
 Rate events·patient−1·yr−10.230.190.023
Severe exacerbations due to ER visits/hospitalisations
 Patients with event n (%)46 (4)31 (3)0.18#
 Rate events·patient−1·yr−10.050.040.38
Adjusted mean change in FEV1 (pre-terbutaline) from baseline0.140.170.066
Adjusted mean change in FEV1 (post-terbutaline) from baseline0.040.070.045
Mean as-needed use inhalations·day−10.930.58<0.001
Adjusted mean change in overall ACQ-5 score from baseline−0.58−0.640.069
Adjusted mean change in overall AQLQ(S) score from baseline0.570.600.51
  • SAL/FLU: salmeterol/fluticasone; BUD/FORM: budesonide/formoterol; ER: emergency room; FEV1: forced expiratory volume in one second; ACQ-5: Asthma Control Questionnaire 5-item score; AQLQ(S): Asthma Quality of Life Questionnaire (Standardised). #: p-values based on the instantaneous risk of experiencing at least one severe exacerbation (Cox proportional hazards model); : p-values based on relative rate analysis (Poisson regression).