JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL

Effectiveness and safety of adjustable maintenance dosing with budesonide/formoterol turbuhaler compared with traditional fixed doses in bronchial asthma: a multi-centre Nigerian study

O M Ige, J O Ohaju-Obodo, C Chukwu, E J Peters, J Okpapi, C Chukwuka
African Journal of Medicine and Medical Sciences 2010, 39 (3): 165-72
21416785
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) ofbudesonide/formoterol (Symbicort, 80/ 4.5 microg and 160/4.5 microg) 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 enrollment 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.

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