Background. Andolast is a new airway specific anti-inflammatory agent. The aim of the present multicentered,
randomized, placebo controlled study is to investigate whether andolast produces a therapeutic response
greater than placebo in asthmatic adult patients.
Methods. 549 symptomatic patients with mild or moderate asthma were randomized to receive andolast at three
different doses (2, 4, or 8 mg t.i.d.) or placebo for 12 weeks. Efficacy and safety were evaluated during scheduled
visits with pulmonary function tests, peak expiratory flow rate (PEFR), symptoms diary and quality of life questionnaire.
The primary outcome included the changes (expressed as percent variation) from baseline of the forced
expiratory volume in one second (FEV1) absolute values after 12 weeks of treatment.
Findings. One hundred and thirty one (131) patients were treated with andolast at the dose of 2 mg t.i.d., 128 patients at the dose of 4 mg
t.i.d., 144 at the dose of 8 mg t.i.d. and 146 with placebo. Andolast produced a dose dependent significant improvement over placebo on
airflow obstruction, as shown by the changes in FEV1 (andolast 2, 4, 8 mg vs. placebo: p = 0.011), especially in a subgroup of patients
showing moderate airways obstruction (FEV1<80%pred). The mean number of asthma control days and free days significantly increased,
the average number of inhaled puffs of short-acting α2-agonists used as rescue medication was significantly reduced as compared with
placebo. Andolast also significantly decreased the incidence of asthma exacerbation episodes.
Conclusion. Andolast proved to be significantly more effective than placebo in improving airflow, and in controlling asthma symptoms
both during day and night.