Publication:

A comparison of the efficacy and safety of daily inhaled budesonide/formoterol and as and when needed inhaled budesonide/formoterol combination in moderate persistent asthma

Background To evaluate efficacy and safety of a fixed dose combination of budesonide/formoterol inhaler, when used as and when needed treatment approach in comparison with similar regimen daily.

Methods A prospective, open label, parallel group study design, in which, screened patients, having moderate persistent asthma, underwent a 2 week of run in period, underwent randomization in two treatment groups, in one group daily treatment with fixed dose combination of budesonide/formoterol inhaler and in another group as and when needed treatment with similar medication. The assessments after baseline were done at 2, 4 and 6 weeks. The primary outcomes were Asthma Control Questionnaire Score (ACQS), asthma free days, exacerbation frequency and severity. Other outcomes were, lung functions, need for rescue medication, Modified Borg dyspnea score and patient preference on VAS.

Results The mean age of 50 patients included in study was 40.24±2.38 years in group I, and 39.24±1.81 years in group II. Patients were followed up for 6 weeks after 2 weeks of run in period. Improvement of ACQS, exacerbation prevention and number of asthma free days were same with both the regimens. Though the drugs taken in as and when needed treatment group was almost half of daily regimen group. Adverse drug reactions (ADRs) were not found in any group. No association between adverse effects and dose was established.

Conclusions Both the treatment regimens improve the asthma control parameters, prevent exacerbations and prevent the decline in lung functions with the similar efficacy and safety. So as and when needed treatment approach can be an alternative to daily regimen for stable moderate persistent asthma patients.