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
Email: This email address is being protected from spambots. You need JavaScript enabled to view it., Mobile: 9337671521
DOI: https://dx.doi.org/10.18535/jmscr/v6i9.20
