[Bronchial asthma treated with long-acting beta 2 agonist. Comparison between formoterol (12 mu/g) inhaled twice daily and salbutamol (200 mu/g) inhaled 4 times daily]

Abstract

Forty patients with stable asthma and daily need for inhaled beta 2-agonist, were included in a randomized double-blind study. They were treated for six weeks with inhaled beta 2-agonist, either salbutamol, 4 x 200 micrograms daily, of formoterol, 2 x 12 micrograms and 2 x placebo daily. This was preceded by a run-in period, where all patients received terbutalin-inhalation, 4 x 500 micrograms daily. Twenty patients were given formoterol and 18 salbutamol. One patient in the salbutamol-treated group discontinued treatment after three weeks, because of deterioration of asthma. On a diary card, patients recorded peak expiratory flow rate (PEFR) morning and evening before medication, score of asthma symptoms (scale 0-3; 0 = no symptoms, and 3 = severe symptoms) and use of additional doses of beta 2-agonist. Forced expiratory volume in 1 sec. (FEV1), forced vital capacity (FVC) and PEFR were obtained after 0, three and six weeks of treatment. Blinded global assessment of the treatment was performed by both patient and physician at the end of the study. During run-in the two groups of patients were different. The group subsequently treated with salbutamol had a statistical significant (ss) higher morning-PEFR, ss fewer asthma-symptom scores than one during night and ss less need for additional puffs of beta 2-agonist. During treatment, the formoterol-treated group showed an ss increase in morning-PEFR, as compared to run-in. Furthermore this group had ss fewer nocturnal symptom scores than one and ss less need for extra beta 2-agonist during night, than the salbutamol-treated group.(ABSTRACT TRUNCATED AT 250 WORDS)