Variable | SAL/FLU + salbutamol | BUD/FORM maintenance + as needed | p-value |
Patients n | 1076 | 1067 | |
All severe exacerbations | |||
Patients with event n (%) | 204 (19) | 159 (15) | 0.0076# |
Rate events·patient−1·yr−1 | 0.31 | 0.24 | 0.0025¶ |
Severe exacerbations excluding unscheduled clinic visits | |||
Patients with event n (%) | 167 (16) | 132 (12) | 0.025# |
Rate events·patient−1·yr−1 | 0.23 | 0.19 | 0.023¶ |
Severe exacerbations due to ER visits/hospitalisations | |||
Patients with event n (%) | 46 (4) | 31 (3) | 0.18# |
Rate events·patient−1·yr−1 | 0.05 | 0.04 | 0.38¶ |
Adjusted mean change in FEV1 (pre-terbutaline) from baseline | 0.14 | 0.17 | 0.066 |
Adjusted mean change in FEV1 (post-terbutaline) from baseline | 0.04 | 0.07 | 0.045 |
Mean as-needed use inhalations·day−1 | 0.93 | 0.58 | <0.001 |
Adjusted mean change in overall ACQ-5 score from baseline | −0.58 | −0.64 | 0.069 |
Adjusted mean change in overall AQLQ(S) score from baseline | 0.57 | 0.60 | 0.51 |
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).