Comparison between formoterol 12 mu g b.i.d. and on-demand salbutamol in moderate persistent asthma

Inhalation of an-demand salbutamol (ODS) several times daily is sometimes t he only Bz-agonist prescribed in moderate persistent asthma, whereas a long -acting beta (2)-agonist should be added. This trial aimed to compare the e fficacy of formoterol dry-powder capsule 12 mug b.i.d. (Foradil((R))) and O DS in patients with moderate persistent asthma treated with inhaled cortido steroids, in the conditions of real practice. Two hundred and fifty-nine pa tients were randomized (formoterol; 130; ODS: 129) in this open, parallel-g roup trial. The mean increases in morning peak expiratory flow (PEF primary variable) and evening PEF over the S-month treatment period were statistic ally significantly higher with formoterol: +25.7 and +24.11 min(-1) respect ively vs. +4.5 and +0.51 min(-1) respectively with ODS. The increase in FEV 1 was statistically significantly higher with formoterol at months I and 3. Formoterol reduced the use of salbutamol as rescue medication by two-third s. The percentages of symptom-free days and nights statistically significan tly increased with formoterol (+20% and +33% respectively), but did not sig nificantly change with ODS. Clinically relevant and statistically significa nt improvement in the mean total score of the St George's Hospital Respirat ory Questionnaire was observed in the formoterol group. Adverse events were similar in the two groups. The results show that treatment with formoterol has significant advantages over ODS in patients with moderate persistent a sthma.