Abstract
BackgroundThe 12-week, multicentre, observational INITIAL study (NCT02143739) assessed asthma severity in newly diagnosed Chinese patients.MethodsPost hoc analysis of medication combinations prescribed per routine clinical practice at baseline, and the impact on control levels evaluated using 2012 vs 2018 Global Initiative for Asthma (GINA) criteria.ResultsIn total, 4491 patients were included in the analysis. At baseline, intermittent, mild, moderate and severe asthma was reported in 3.9, 12.0, 22.6 and 61.6% of patients, respectively. Most patients (90.2%) were prescribed inhaled corticosteroid/long-acting β2 agonist (ICS/LABA). ICS/LABA plus ≥1 additional medication(s) was prescribed to 66.7% of patients, with leukotriene receptor antagonist (LTRA, 54.7%) being the most common additional medication. Distribution of ICS/LABA vs ICS/LABA+LTRA was comparable in patients with intermittent (3.2% vs 3.0%), mild (11.5% vs 9.7%), moderate (21.2% vs 19.9%) and severe asthma (64.1% vs 67.4%). Control levels among patients using ICS/LABA+LTRA vs ICS/LABA were comparable using GINA 2012 and lower using GINA 2018 criteria.The proportion of patients using ICS/LABA+LTRA vs ICS/LABA with intermittent, mild, moderate and severe asthma controlled at Week 12 (using GINA 2012) were 78.1% vs 80.0, 86.5% vs 85.8, 78.5% vs 71.3, and 59.6% vs 61.8%, respectively. Using GINA 2018 criteria proportions were 86.8% vs 95.9, 86.1% vs 93.2, 82.1% vs 85.3, and 71.9% vs 77.6%, respectively.ConclusionsAsthma control was not improved by adding LTRA to ICS/LABA and may have been unnecessary for some newly diagnosed patients. These findings were irrespective of the GINA criteria (2012 vs 2018) used and baseline severity.
Highlights
The 12-week, multicentre, observational INITIAL study (NCT02143739) assessed asthma severity in newly diagnosed Chinese patients
Criteria used to assess current clinical control have evolved from a combination of symptoms and lung function endorsed by Global Initiative for Asthma (GINA) 2012 [1] to symptoms alone in GINA 2014 [3] and subsequent GINA updates [2]
Diagnosis of asthma was made based on lung function test, the gold standard for asthma diagnosis, and based on symptoms typical of asthma, in accord with criteria recommended by Chinese guidelines for the prevention and management of bronchial asthma (2008, [14])
Summary
The 12-week, multicentre, observational INITIAL study (NCT02143739) assessed asthma severity in newly diagnosed Chinese patients. Two pivotal long-term goals of asthma management are symptom control and risk reduction [1]. Evaluation of symptom control constitutes the basis of treatment decisions in a continuous asthma management cycle composed of assessment, treatment adjustment, and response review recommended by the Global Initiative for Asthma (GINA) [1, 2]. Inhaled corticosteroids (ICS) with or without longacting β2 agonist (LABA) has been recommended by GINA as the mainstay initial controller treatment, and leukotriene receptor antagonist (LTRA) may be considered as an alternative option or add-on medication at step 2 to 4 [2]. In China, a survey involving two provinces showed that LTRA was frequently prescribed in combination with ICS/LABA for patients with severe asthma (87.5% [49/56]) [12]
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