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.

Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1

Patient flow. *One patient was considered to have completed the study as they were interviewed by telephone at Week 12 despite being considered discontinued by investigators. FAS, full analysis set.

Figure 2

GINA 2012-defined asthma control levels. *Missing data for one patient; †Missing data for 2942 patients; ‡Missing data for 2947 patients; §Missing data for 964 patients.