A Randomized Controlled Open Label Study to Compare the Efficacy and Tolerability of Budesonide / Formoterol Single Inhaler Therapy versus Fluticasone / Salmeterol as Maintenance and Reliever Therapy in Moderate Asthma.
Journal Title: International Journal of Medical Science and Innovative Research (IJMSIR) - Year 2017, Vol 2, Issue 6
Abstract
Achieving and maintaining asthma control is the major goal of asthma care, based on the Global Initiative for Asthma (GINA) 2011 guidelines.(1) International guidelines recommend the combination of a long-acting beta2-agonist (LABA) with low-to-medium dose inhaled corticosteroids (ICS) if asthma is not fully controlled by ICS alone, as first choice treatment in moderate asthma. It is used as maintenance therapy with a short acting beta2-agonist ( SABA ) as a reliever therapy.(2)(3) The use of one inhaler for both maintenance and as needed reliever medication, simplifies asthma therapy, which is likely to improve patient adherence. The objective of this study was to compare the efficacy of budesonide/formoterol single inhaler therapy as maintenance and reliever therapy versus fluticasone/salmeterol with as needed SABA (levosalbutamol) in patients with moderate asthma. Methods: A randomized controlled open label comparative, parallel group study with a duration of 6 months. 96 patients diagnosed clinically with moderate asthma, attending outpatient clinic department of chest medicine were recruited based on the inclusion and exclusion criteria. Subjects were randomized into two groups of 48 each. They received either budesonide/formoterol 160/4.5 µg one inhalation twice daily, plus additional inhalations as needed (budesonide/formoterol single inhaler therapy) or fluticasone /salmeterol 50/250 µg one inhalation twice daily, plus levosalbutamol for rescue medication. Assessments were done by evaluating, pulmonary function parameters, asthma control (ACQ5) and Quality of Life ( miniAQLQ) at baseline, 4 weeks, and a 6 month telephonic follow up of asthma control (ACQ5) and Quality of Life( miniAQLQ). Results: On comparing the efficacy of the two groups, patients on budesonide/formoterol group had greater improvements in asthma control (ACQ5 overall score, percent of patients with a clinically significant improvement of 0.5 on the ACQ5 ) at 4 week visit and 6 month telephonic follow up. The improvement in pulmonary function parameters (FVC,PEF) and small airway involvement ( FEF 25-75) were statistically significant with a p value of 0.015,<0.001<0.001,<0.001,0.008 respectively . Budesonide/formoterol group had greater improvements in symptoms, activity, social , environment sub-domains of mini AQLQ score, which was statistically significant with a p value of<0.001, <0.001,<0.001,<0.001 respectively. Conclusion: It can be concluded from this study that single-inhaler therapy with budesonide/formoterol for maintenance and relief, having an increased efficacy and ease of administration, does provide an improvement in patients with moderate asthma.
Authors and Affiliations
Dr Pritam Biswas
Keywords
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