Resumé
The modern treatment guideline of bronchial asthma recognize that combination of long acting beta2 -agonists and inhaled glucocorticoids, enables better control of inflammation and symptoms of asthma than inhaled glucocorticoids only. These guidelines recommended that patients are educated to adjust their medication to their asthma severity using physician-guided self-management plans. However, many patients take a fixed dose of their controller medication and adjust their reliever medication to asthma symptoms Therefore, combination of formoterol and budesonide can be delivered at different dosing level without the need to change inhalers. This study examined whether asthma control improved if patients adjusted the maintenance doses(AMD) of budesonide/formoterol (Symbicort, 80/4.5µg and 160/4.5μg) according to asthma severity compared with traditional fixed dosing(FD) regimens. This was a prospective open randomized trial carried out in five teaching hospitals across Nigeria between 15th July 2002 and 15th July 2003. Patients with bronchial asthma who met the enrolment criteria were randomized to receive either
adjustable dosing or fixed dosing for a period of twelve weeks. The results obtained at the start and the end of the study showed that budesonide/formoterol combination effectively achieved and maintained control of asthma. The adjustable dosing achieves more effective control compared to fixed dosing in terms of the number of patients that are redistributed to less severe forms of persistent asthma. The percentage of patients with intermittent asthma increased from 9.3% at randomization to 55.6% at the end of therapy with more patients at the AMD arm of treatment. Also for mild persistent asthma there was an increase from 20.4% to 24.1%. This showed that at the end of treatment, majority (79.7%) of the patients had intermittent and mild persistent asthma. The frequency of use of budesonide/formoterol in the two arms of treatment showed that patients in the adjustable groups used less number of inhalations of budesonide/formoterol for treatment on average of 2.5 inhalations per day compared to those on fixed dosing who used 4 inhalations per day (p=0.0001). The number of times patients stayed awake because of asthma was noticed to be more reduced at the adjustable arm of treatment but this was of no statistical significance. It is therefore concluded, that budesonide/formoterol combination in a single inhaler is a simple, well tolerated, convenient treatment which provides effective control of bronchial asthma using a practical self-management plan consistent with current guidelines.
Keywords: Bronchial asthma, budesonide/formoterol, adjustable dosing, fixed dosing, efficacy, safety.
Résumé
Le guide du traitement moderne de l’asthme bronchiale reconnait que la combinaison des agonistes beta a longue durée et l’inhalation des glucocorticoïdes, aide à contrôle l’inflammation et les symptômes de l’asthme que les glucocorticoïdes seulement. Ces guides recommandaient que les patients sont éduqués a ajuster leur médication a la sévérité de l’asthme en utilisant les plans de guide du médecin. Cependant, Plusieurs patients prennent la dose fixe de leur médication contrôleur et ajustent leur médication des symptômes de l’asthme. Ainsi, la combinaison du formoterol et budesonide peut être délivré a différentes doses sans avoir besoin de changer le glucorticoide. Cette étude examine si l’asthme contrôle s’améliorait si le patient ajuste la dose de maintenance(AMD) de budesonide/formoterol (Symbicort, 80/4.5µg et 160/4.5μg) en fonction de la sévérité de l’asthme comparée au régime de dose fixe traditionnelle(FD). Cette étude prospective ouverte était faite dans cinq centres universitaires hospitaliers au Nigeria entre 15th Juillet 2002 et 15th Juillet 2003. Les patients avec asthme bronchiale satisfaisant les critères d’inclusion étaient admise et recevaient une dose ajustée ou fixe du médicament pour une période de douze semaines. Les résultats obtenus au départ et a la fin de l’étude démontraient que la combinaison budesonide/formoterol maintenait effectivement le contrôle de l’asthme. La dose ajustée apportait une meilleur contrôle comparée a la dose fixe en terme de nombre de patients redistributes a la forme moins sévère de l’asthme persistent. Le pourcentage des patients ayant l’asthme intermittent augmentaient de 9.3% au hasard a 55.6% a la fin de l’étude avec plus de patients dans le groupe de la dose ajustée. Aussi l’asthme légère et persistent augmentait de 20.4% a 24.1%. Ceci montrait qu’à la fin des deux traitements, la majorité (79.7%) des patients avaient l’asthme intermittent et légèrement persistent. La fréquence de l’usage de la budesonide/formoterol dans les deux groupes de traitement démontraient que les patients dans le groupe de traitement ajusté utilisaient moins de glucocorticoïdes de budesonide/formoterol en moyenne 2.5 fois par jour comparée a la dose fixe de 4 fois par jour (p=0.0001). Le nombre de fois que les patients restaient éveillés a cause de l’asthme était plus réduit a ceux utilisant les doses ajustées mais n’était pas statistiquement significatif. Il est ainsi conclu que la combinaison desonide/formoterol inhalée est simple, bien tolérée, un traitement convenable qui aide a contrôle effectivement l’asthme bronchiale en utilisant un plan de ménagement autonome, pratique et consistent avec les guides récentes.
Correspondence: Dr. O.M. Ige, Department of Medicine, University College Hospital, Ibadan, Nigeria. E-mail: olusojiige@yahoo.com
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