Efficacy of inhaled @entity10453 in the management of smokers with XXXX : a single centre randomised, double blind, placebo controlled, crossover study.

@entity1 @entity3045 @entity1030 @entity3885 @entity10453
BACKGROUND: The acute response to bronchodilators in @entity1 with @entity1030 ( @entity1030 ) is modest; it has, however, been suggested that these @entity1 may benefit from long term treatment. METHODS: To investigate the efficacy of @entity10453 in smokers with moderate to severe @entity1030 a double blind, randomised, crossover comparison was performed between @entity10453 (50 micrograms twice daily) and placebo in 63 @entity1 with stable @entity1030 (mean age 65 years). Prior to inclusion, all @entity1 had a forced expiratory volume in one second (FEV1) of < 60% of predicted and an improvement in FEV1 of < 15% following 400 micrograms inhaled @entity3045 . @entity1 received four weeks of therapy with each of the treatment regimens. Assessment of efficacy was made with recording of morning and evening peak expiratory flow rates (PEF), respiratory symptoms, and use of rescue @entity3045 . FEV1 was measured before and after nebulised @entity3045 prior to randomisation and at the end of each treatment period. RESULTS: Morning PEF values were higher during the @entity10453 than during the placebo period, although the mean treatment difference was small (12 l/min (95% confidence limits 6 to 17)). No difference in mean evening PEF values was found. Diurnal variation in PEF, assessed as the difference between the morning PEF and that of the previous evening, was more pronounced during the placebo than during the @entity10453 period. The mean spirometric values (including reversibility in FEV1) obtained at the end of the two treatment periods were similar. Compared with placebo, treatment with @entity10453 was associated with lower daytime and night time symptom scores and less use of rescue @entity3045 both during the day and the night. The @entity1 rated the treatment with @entity10453 better than treatment with placebo. CONCLUSIONS: This study shows that, compared with placebo, treatment with @entity10453 produces an improvement in respiratory symptoms and morning PEF values in @entity1 with moderate to severe @entity1030 . Treatment with long acting beta agonists may therefore result in an improvement in functional status, even in @entity1 suffering from apparently nonreversible @entity3885 .
