Asthma control with ICS-formoterol reliever versus maintenance ICS and SABA reliever therapy: a post hoc analysis of two randomised controlled trials

Abstract

Background: In randomised controlled trials, as-needed inhaled corticosteroid (ICS)-formoterol reliever therapy reduces severe exacerbation risk compared with maintenance ICS plus short-acting beta₂-agonist (SABA) reliever in adolescent and adult asthma, but results in slightly worse control of asthma symptoms, as measured by mean Asthma Control Questionnaire-5 (ACQ-5) score.

Objective: To assess the levels and changes in asthma control for as-needed budesonide-formoterol versus maintenance budesonide plus SABA in post hoc analyses from the Novel START and PRACTICAL clinical trials.

Methods: The number and proportion of participants at study end in each ACQ-5 category ('well-controlled', 'partly controlled' or 'inadequately controlled' symptoms), and in each responder category based on the minimal clinically important difference for ACQ-5 of 0.5 (improved, no change and worse) with as-needed budesonide-formoterol and maintenance budesonide plus SABA treatment were calculated.

Results: With last observation carried forwards, 189/214 (88.3%) and 354/434 (81.6%) of patients in the budesonide-formoterol group had 'well-controlled' or 'partly controlled' symptoms at the end of the study, vs 183/214 (85.5%) and 358/431 (83.1%) in the budesonide maintenance group, for Novel START and PRACTICAL, respectively. The proportion of patients whose symptom control was either improved or unchanged from baseline was 190/214 (88.8%) and 368/434 (84.8%) for budesonide-formoterol, vs 185/214 (86.4%) and 376/431 (87.2%) for maintenance budesonide, in Novel START and PRACTICAL respectively.

Conclusions: There were no clinically important differences in the proportions of patients with 'well-controlled' or 'partly controlled' asthma symptoms, or proportions who improved or maintained their level of control, with as-needed budesonide-formoterol versus maintenance budesonide plus SABA.

Keywords: Asthma; Inhaler devices.

Figure 1

Frequency (n) of participants in each ACQ-5 group category with ‘well-controlled’ (≤0.75), ‘partly controlled’ (>0.75 to <1.5) and ‘inadequately controlled’ (≥1.5) asthma at baseline and end of study (last observation carried forward), and the changes in flow between them, for Novel START. The darkest shades of red and blue denote ‘inadequately controlled’ asthma, and the lightest shades, ‘well-controlled’ asthma. The shades between represent ‘partly controlled’ asthma. The colour of the flow between visits (nodes) represents the ACQ-5 group category at Visit 1. Missing data are excluded. ACQ-5, Asthma Control Questionnaire-5.

Figure 2

Frequency (n) of participants in each ACQ-5 group category with ‘well-controlled’ (≤0.75), ‘partly controlled’ (>0.75 to <1.5) and ‘inadequately controlled’ (≥1.5) asthma at baseline and end of study (last observation carried forward), and the changes in flow between them, for PRACTICAL. The darkest shades of red and blue denote ‘inadequately controlled’ asthma and the lightest shades, ‘well-controlled’ asthma. The shades between represent ‘partly controlled’ asthma. The colour of the flow between visits (nodes) represents the ACQ-5 group category at visit 1. Missing data are excluded. ACQ-5, Asthma Control Questionnaire-5.

Figure 3

Proportion (%) of participants with clinically relevant changes in ACQ-5 Scores (improved, no difference, worse) from baseline to end of study (last observation carried forward) for Novel START and PRACTICAL. The darkest shades of red and blue denote ‘worse’ asthma control and the lightest shades, ‘improved’. The shades between represent ‘no difference’. ACQ-5, Asthma Control Questionnaire-5.