INITIAL – An observational study of disease severity in newly diagnosed asthma patients and initial response following 12 weeks’ treatment

Abstract

In China, there are an estimated 30 million people with asthma, a condition that remains poorly controlled in many patients. The INITIAL study (NCT02143739) was a 12-week, multicentre, prospective, observational study comprising 45 centres across Northern and Southern China that aimed to assess asthma severity among newly diagnosed patients as well as their prescribed medications and response to treatment. The primary objective was to evaluate asthma severity using Global Initiative for Asthma (GINA) 2006 research criteria. Secondary objectives included the distribution of asthma medication by GINA severity category and evaluation of GINA 2012-defined control levels. Medications were prescribed as per usual clinical practice. At baseline, among 4491 patients, 3.9%, 12.0%, 22.6% and 61.6% had intermittent, mild persistent, moderate persistent and severe persistent asthma, respectively. Inhaled corticosteroid/long-acting β2 agonist was the most common initial therapy in 90.2% of patients. GINA 2012-defined controlled asthma levels increased in all groups, rising from 6.1% at baseline to 43.0%, 53.8% and 67.8% at Weeks 4, 8 and 12, respectively. Most patients presented with severe persistent asthma. Newly diagnosed patients with asthma could benefit from at least 3 months of regular treatment followed by long-term pharmacological management.

Post hoc analysis of initial treatments and control status in the INITIAL study: an observational study of newly diagnosed patients with asthma

“…The addition of a third controller (LTRA or theophylline) is an option for patients who are not adequately controlled with a medium-dose ICS/LABA after a trial of 2-3 months for patients at Step 4 [1,2]. Among ICS/LABA medications, budesonide/formoterol is recommended by GINA 2019 as the preferred formulation of ICS-formoterol at step 1 and 2 based on the evidence of efficacy, and it was also the predominant form used in our population at baseline (88.9%, 3602/4051) [13], probably because of their availability in one inhaler (e.g. Symbicort) and easy inhaler techniques.…”

“…This was a post hoc analysis of a 12-week, multicentre, prospective, observational study performed in patients with asthma from 45 centres across Northern and Southern China between June 2014 and September 2016 (INITIAL, NCT02143739). The protocol, full details of the study population and overall results have previously been reported [13]. Methods specific to this post hoc analysis are briefly described below.…”

“…This post hoc analysis included all 4492 patients in the full analysis set (FAS), and overall, 3587 (74.5%) completed the study (Table 1) [13].…”

“…The INITIAL study (NCT02143739) was a 12-week, multicentre, prospective, observational study of patients with asthma comprising 45 centres across Northern and Southern China [13]. The study aimed to assess asthma severity among newly diagnosed patients as well as their prescribed medications and response to treatment.…”

“…The study aimed to assess asthma severity among newly diagnosed patients as well as their prescribed medications and response to treatment. In the primary analysis of INITIAL data, we observed a high rate of LTRA prescription at baseline ( [13]. The current analysis was conducted to further investigate the medications and medication combinations prescribed at baseline during the INITIAL study, with a focus on ICS/LABA and ICS/LABA plus LTRA, and to determine the impact of the change in asthma control criteria between the Global Initiative for Asthma (GINA) 2012 [1] and 2018 guidelines [2].…”