Comparing the Asthma Control and Anti-inflammatory Effects of Different Fixed Combinations of Inhaled Corticosteroids Plus Long-acting Beta 2 Agonist; A Randomized Clinical Trial

Abstract

Background: Asthma is the most common chronic inflammatory disease of the pulmonary system. The prevalence of asthma is growing enormously worldwide posing a significant health and economic burden. Asthma treatment guidelines recommend a combination of inhaled corticosteroid (ICS) and long-acting beta 2 agonist (LABA). However, there is little guidance for clinicians on selecting a specific ICS/LABA combination.
 Aim: To compare the effectiveness of three fixed dose ICS/LABA combination therapies i.e., fluticasone/salmeterol, fluticasone/formoterol and budesonide/formoterol for the management of moderate to severe asthma.
 Design: This was a prospective interventional, three-armed, parallel group, open label, and randomized clinical trial
 Methods: Adult asthmatic patients of both genders (n=135) were randomly allocated to the three ICS/LABA treatment groups: fluticasone/salmeterol-treated group (n=45) , fluticasone/formoterol-treated group (n=45) and budesonide/formoterol-treated group (n=45). All groups were treated for three months. The main outcome parameters included lung function (FEV1, FEV1%, FEV1/FVC), inflammatory state (hs-CRP, ECP) and asthma control (ACT).
 Results: After 3 months of treatment, fluticasone/formoterol significantly increased FEV1 compared to fluticasone/salmeterol (p<0.01) and FEV1% compared to budesonide/formoterol (p<0.01). Both fluticasone-containing combinations significantly increased FEV1/FVC (p<0.001, p<0.001), decreased serum hs-CRP (p<0.01, p<0.001), and serum ECP (p<0.05, p<0.001) and improved ACT (p<0.05, p<0.01) compared to budesonide. Fluticasone/formoterol significantly reduced ECP in comparison to fluticasone/salmeterol (p<0.05).
 Conclusion: Our study showed a superiority for fluticasone-containing combinations over budesonide for the treatment of moderate to severe asthma. Within the former combinations, fluticasone/formoterol was better than fluticasone/salmeterol.