Prescribing information


One-year follow-up of asthmatic patients newly initiated on treatment with medium- or high-dose long-acting beta2-agonist/inhaled corticosteroid (LABA/ICS) in UK primary care settings1

  • Approximately 39% of patients with asthma remain uncontrolled, despite current treatment with inhaled therapies1


What was already known?

  • Global Initiative for Asthma (GINA) 2020 strategy recommends low- to high-dose LABA/ICS as preferred controller treatments for patients with moderate or moderate to severe asthma2
  • Many patients with asthma remain uncontrolled on medium- or high-dose LABA/ICS and have higher rates of morbidity, mortality and healthcare resource utilisation compared with patients whose asthma is controlled1,3,4
  • For patients whose asthma remains uncontrolled on LABA/ICS, GINA recommends an increase in the dose of ICS or addition of one or more controllers such as a long-acting muscarinic antagonist (LAMA) or leukotriene receptor antagonist (LTRA), before stepping up to biologics and/or low-dose maintenance oral corticosteroid (OCS)2


Why was this study conducted?1

  • To understand the level of control in moderate to severe asthma patients initiated on medium- or high-dose LABA/ICS
  • To evaluate how physicians choose step-up options for medium- or high-dose LABA/ICS in real-world clinical practice
  • To examine asthma control in patients who were adherent to their LABA/ICS therapy


Study design1

  •  Retrospective cohort study

Objectives and endpoints1

  • Asthma control in the follow-up period, assessed using a composite outcome including moderate or severe exacerbations, treatment step-up, and short-acting beta2-agonist use ≥450 µg Defined Daily Dose per year; patients with any occurrence of one or more of these events were identified as uncontrolled
    • An exacerbation was considered moderate if managed in primary care, i.e. asthma-related general practitioner (GP) visit and OCS burst; severe exacerbations were defined as asthma-related hospitalisation or accident and emergency visit
    • Treatment step-up was either addition of one or more asthma controllers, including LAMA, LTRA, theophylline, or maintenance OCS in patients of both LABA/ICS cohorts, and increase in ICS dose only in the medium-dose LABA/ICS cohort
  • Adherence to treatment, defined as Medication Possession Ratio (MPR) of ≥80%
  • Changes in asthma treatments post medium- or high-dose LABA/ICS implemented by GPs, percentage of patients who stepped up or stepped down, and medications that patients stepped up/down to were also examined during the follow-up period. Healthcare resource utilisation in medium- and high-dose LABA/ICS cohorts was assessed in terms of asthma-specific prescriptions and rates of specialist referral and hospitalisations


Included patients1

  • Patients newly initiated on medium- or high-dose LABA/ICS identified in Clinical Practice Research Datalink with linked Hospital Episode Statistics data between 01/01/2006 and 28/02/2016
  • A total of 29,229 and 16,575 patients initiated medium- and high-dose LABA/ICS, respectively
  • Patients could be included in both cohorts at different time periods


What are the results of the study and why are they relevant?1

Asthma control

  • 35.1% (medium-dose cohort) and 45.7% (high-dose cohort) of asthma patients on newly initiated LABA/ICS remain uncontrolled in the UK
  • 63.8% (medium-dose cohort) and 70.0% (high-dose cohort) of patients with asthma who were adherent to LABA/ICS (MPR ≥80%) remain uncontrolled
  • LTRA and LAMA were the preferred add-on medication to LABA/ICS among patients with uncontrolled asthma
  • 41.1% of patients with uncontrolled asthma in medium-dose and 31.2% in high-dose LABA/ICS cohort had no treatment step-up
  • Healthcare resource utilisation was high in patients with uncontrolled asthma, regardless of the LABA/ICS dose

Treatment adherence

  • 37.8% and 49.1% of patients on medium- and high-dose LABA/ICS respectively were considered to be adherent to their treatment regimen (MPR ≥80%)


Implications for clinical practice1

A significant proportion of patients newly initiated on medium- or high-dose LABA/ICS therapy remain uncontrolled and at risk of exacerbation even when adherent to these treatments, highlighting the need for timely assessment of asthma control and stepping-up of therapy.


Indication: ENERZAIR BREEZHALER is indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.5

GINA, Global Initiative for Asthma; GP, general practitioner; ICS, inhaled corticosteroid; LABA, long-acting beta2-agonist; LAMA, long-acting muscarinic antagonist; LTRA, leukotriene receptor antagonist; MPR, Medication Possession Ratio; OCS, oral corticosteroid.


  1. Buhl R et al. Respir Med 2019;162:105859 [Epub ahead of print].
  2. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2020. Available at: Date accessed: December 2020.
  3. Schatz M et al. J Allergy Clin Immunol Pract 2014;2(5):570–574.
  4. Lang D. Allergy Asthma Proc 2015;36(6):418–424.
  5. ENERZAIR BREEZHALER Summary of Product Characteristics.


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UK | February 2021 | 103407

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