Abstract

A COMPARISON OF EFFICACY AND SAFETY OF FIXED DOSE COMBINATION OF BUDESONIDE/FORMOTEROL USING PRESSURISED METERED DOSE INHALERS (PMDI) AND DRY POWDER INHALERS (DPI) IN PATIENTS OF MODERATE PERSISTENT ASTHMA

Gupta M. C., Khanna J.* and Chaudhry D.

ABSTRACT

Background: Inhalers like pressurized metered dose inhalers (pMDIs) and dry powder inhalers (DPIs) that contain a corticosteroid and a long acting β2 agonist (LABA) (e.g. budesonide/formoterol) are widely used in asthma treatment. This study compared the efficacy and safety of pMDI and DPI using the Fixed dose combination (FDC) in patients of moderate persistent asthma. Methods: This was a 6 week prospective, randomized, open label, comparative, parallel group clinical study. All patients had a forced expiratory volume in 1 second (FEV1) of 60–80% predicted normal. Following 1-week run-in, patients were randomised to receive budesonide/formoterol 200/6 μg by pMDI with spacer in group I and DPI in group II. The primary efficacy end-points were change from baseline in lung function tests (FVC, FEV1, FEV1/FVC and PEFR) and asthma control questionnaire measured in both the groups at 0, 2, 4 and 6 weeks. The secondary efficacy end-points were asthma free days, exacerbation frequency and severity and need for rescue medication. Safety assessment was primarily done by a fixed proforma. Results: Fifty patients completed the study. Both the groups showed statistically significant improvement in lung functions. Similar improvements were seen for secondary efficacy end-points. Tolerability of DPIs is better than pMDIs. Conclusions: Since tolerability of DPI is better than pMDI it can be a better alternate in patients of moderate persistent asthma.

Keywords: Moderate persistent asthma, asthma control Questionnaire, asthma free days, Fixed dose combination of budesonide formoterol, pressurized metered dose inhaler (pMDI), dry powder inhaler (DPI).