Can a new beta 2-agonist reduce the mortality of asthma?

Tulobuterol is a synthetic beta-adrenergic agonist which, when administered orally, is a potent, long-acting bronchodilator. The safety and efficacy of 2 mg tulobuterol tablets taken twice daily was compared to that of 4 mg salbutamol tablets taken three times daily for a period of 12 weeks in outpatients with stable chronic asthma in a randomized, double-blind, multi-center study conducted in Australia. Strict entry criteria were employed; only those patients whose baseline FEV1 value was between 40-70% of the predicted normal value and increased at least 20% after two inhalations of a metered dose (250 micrograms per dose) of terbutaline aerosol at a screening visit were included. Treatment with active study drug was preceded by a 2 week single-blind, placebo lead-in period. The onset and duration of the bronchodilating effect was studied on the first day of the placebo lead-in period and on the first and last days of the 12 week parallel design treatment period. Of 140 patients enrolled, 73 had tulobuterol and 67 had salbutamol. Of these, 61 tulobuterol and 59 salbutamol treated patients could be evaluated for efficacy. Of the 140 patients, 129 completed the study. All patients were issued a mini peak flow meter and diary cards to record daily PEFRs and symptoms of airways obstruction throughout the study. The demographics of the patients in both treatment groups were similar in all modalities: they were comparable in age, duration of asthma, mean FEV1 (expressed as percent of predicted normal), and reversibility (as demonstrated by an increase in FEV1 after administration of a beta 2-agonist aerosol).(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes