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

Ashraf Elsayed Sileem; Ahmed Ali; Hanan Elnahas; Ahmed M. Gouda

doi:10.3889/oamjms.2021.6548

Authors

Ashraf Elsayed Sileem Department of Chest Diseases, Faculty of Medicine, Zagazig University, Zagazig, Egypt https://orcid.org/0000-0002-8674-0493
Ahmed Ali Department of Clinical Pharmacy
Hanan Elnahas Department of Pharmaceutical and Industrial Pharmacy, Faculty of Pharmacy, Zagazig University, Zagazig, Egypt https://orcid.org/0000-0002-9148-3276
Ahmed M. Gouda Department of Pharmacy Practice, Faculty of Pharmacy, Zagazig University, Zagazig, Egypt https://orcid.org/0000-0002-7199-7480

DOI:

https://doi.org/10.3889/oamjms.2021.6548

Keywords:

Asthma, Asthma management, Inhaled corticosteroids, Bronchodilators

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.

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