Title: Fluticasone/Formoterol dry powder versus Budesonide/Formoterol in adults and adolescents with uncontrolled or partly controlled asthma

Authors: Dr Sanjay Kumar Jangid, Dr Sarat Kumar Behera, Sudeep Kumar Patra, Saiprasanna Behera

 DOI:  https://dx.doi.org/10.18535/jmscr/v6i9.20

Abstract

This 12-week study compared the efficacy and safety of a fixed combination of fluticasone propionate plus formoterol (FL/F) 250/12 μgb.i.d. administered via a dry powder inhaler (DPI) to a combination of budesonide plus formoterol (BD/F) 400/12 μgb.i.d. After a 2-week run-in period (in which all patients were treated exclusively with budesonide plus formoterol), patients aged 12–65 years of age (N = 98) with uncontrolled asthma were randomized into an actively controlled, open-labelled, parallel-group study. The primary objective was to demonstrate non-inferiority, measured by morning peak expiratory flow (mPEF).

The non-inferiority was demonstrated. A statistically significant improvement from baseline was observed in both groups in terms of lung function, asthma control, and the use of rescue medication. FL/F demonstrated a statistical superiority to BD/F in terms of lung function (FEV1) (p = 0.01) and for asthma control (p = 0.02). Non-significant between-group differences were observed with regards to exacerbation rates and adverse events.

In uncontrolled or partly controlled asthma patients, the use of a combination of fluticasone propionate plus formoterol via DPI for 12-weeks was non-inferior and showed improvements in FEV1 and asthma control when compared to a combination of budesonide plus formoterol.

Keywords: Asthma control questionnaire; Forced expiratory volume in 1s; Single inhaler; Non-inferiority; Morning peak expiratory flow.

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Corresponding Author

Dr Sanjay Kumar Jangid

Associate Professor, Department of General Medicine, Hi-tech Medical College and Hospital Bhubaneswar-751025 Odisha, India

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