Tullio C. Medici

Clinical Experience over Five Years of Daily Therapy with Formoterol in Patients with Bronchial Asthma

SummaryThis study investigated regular treatment with the long-acting β2-agonist formoterol over 5 years in patients with predominantly moderate to severe bronchial asthma. It was an open, prospective, surveillance study in 54 randomly selected asthmatics that considered concomitant medication, pulmonary function, exacerbations and the patients’ subjective condition. The objective findings were compared with the corresponding data for the previous 12 months. Five follow-up examinations were carried out for 5 consecutive years. The mean number of 12µg puffs of formoterol inhaled per day over 5 years was 2.5, 2.5, 2.6, 2.5 and 2.2, for each consecutive year. The number of patients who used an electric nebuliser fell from 41 (pretrial period) to 6, 4, 3, 1 and 1, consecutively over the 5-year period (p < 0.001). The total number of patients using theophylline fell from 31 to 9 in the first year, and dropped to 4 at the end of the trial (p < 0.001). The percentage of patients on inhaled corticosteroids remained more or less constant (72 vs 75%). The mean daily use of beclomethasone dipropionate decreased from 2.8 to 1.9 puffs daily after 1 year and remained at this level (p < 0.05). During the pretrial period, 27 patients had exacerbations necessitating treatment with systemic corticosteroids. This number fell to 12, 5, 11, 6 and 9 over the consecutive years, and the mean number of interventions decreased from 1.6 to 0.2 at the end of the trial (p < 0.001). Over 5 years of treatment, the mean decrease in forced expiratory volume in the first second (FEV1) was 0.11 ±0.52L and the mean reversibility fell by 0.001 ± 0.36L, indicating a high stability of lung function. Adverse effects occurred in 19 of 66 patients (29%). Two patients died. Neither of the deaths was judged to be related to the therapy with formoterol. In conclusion, regular therapy with formoterol appears to be very useful; there was a significant reduction in concomitant use of asthma drugs, with well-preserved pulmonary function, better subjective condition and less need for corticosteroid intervention treatment. No increase in the formoterol dose was observed, indicating no clinically relevant development of tolerance. Furthermore, no patient had to be withdrawn because of adverse effects.