Table 1. Effect of ICS+formoterol as-needed therapy*¹.

Patients at step 1 or 2	Compared with SABA as-needed therapy	Compared with ICS maintenance therapy
Lung function (FEV1)	+ 30 mL 95% CI: [6; 70 mL]	+ 4 mL 95% CI: [–30; 40 mL]
All exacerbations	RR 0.49*2 95% CI: [0.33; 0.72]	RR 1.12 95% CI: [0.70; 1.79]
Severe exacerbations	RR 0.40*2 95% CI: [0.18; 0.86]	RR 0.44*2 95% CI: [0.20; 0.96])

*¹ In the open (nonmasked) Novel-START study, 668 patients with asthma at step 1 or step 2 (“mild asthma”) were randomized into three treatment arms:

1) Salbutamol only, as needed,

2) Maintenance ICS (2 × 200 µg budesonide by Turbuhaler daily) plus salbutamol as needed, or

3) ICS+formoterol as needed (by inhalation of a fixed-dose combination of 200 µg budesonide and 6 µg formoterol as needed).

The table shows changes in forced expiratory pressure (FEV₁) and risk reduction (RR) for the occurrence of exacerbations after 52 weeks of ICS+formoterol as-needed treatment in comparison with the other two treatment arms. Severe exacerbations were defined by the need to use systemic corticosteroids. ICS, inhaled corticosteroids; CI, confidence interval; SABA, short-acting inhaled β₂ -agonist

*² p <0.001