• A-B Tonnel and J-L Desfougères.
• Service de Pneumologie et Immuno-Allergologie, Hôpital Calmette, CHRU, boulevard du Pr-Jules-Leclercq, 59037 Lille Cedex. ab-tonnel@chru-lille.fr
• Rev Pneumol Clin. 2004 Sep 1;60(4):209-16.

BackgroundThe objective of an asthma treatment is to control asthma, particularly to prevent exacerbations.ObjectiveTo study the efficacy, acceptability and safety of the fluticasone/salmeterol (FP/S) combination in preventing asthma exacerbations in comparison with the continuation of previous treatment (TA).MethodsThis was a multicentre, randomised, parallel-group study to compare the fixed combination FP/S to TA (treatment with a free combination of an inhaled corticosteroid and a long-acting beta2-agonist) over one year in patients whose asthma was well controlled with their current treatment.ResultsFive hundred and twenty patients were randomized and their data analyzed on an intent-to-treat basis. Seventy-four percent of the patients in the FP/S group and 71% in the TA group had no exacerbation. The 3.12% difference in favor of the FP/S group (90% CI: -3.32% to 9.56%) demonstrated that FP/S was at least as effective TA in preventing asthma exacerbations. Treatment acceptability, evaluated by the patient on visual analog scales (inclusion as part of the daily habits, constraint, simplicity) was better with FP/S (p<0.001) than with TA. Clinical safety was good and comparable in the two groups.ConclusionThe fixed fluticasone/salmeterol combination provided a protection as good as that obtained with free combinations over a one-year treatment period, with a significant improvement in treatment acceptability and a good clinical safety.

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