Asthma is a chronic respiratory condition associated with airway inflammation and bronchial hyper-reactivity [1]. Airway inflammation occurs as a result of mucus plugging and bronchoconstriction due to mast cell degranulation and histamine release in response to allergen exposure [2].

Asthma is the most common lung disease, with over 12% of the United Kingdom (UK) population receiving an asthma diagnosis [3]. In 2019, asthma affected an estimated 262 million people and caused 455,000 deaths [4]. These deaths are largely due to exacerbations. When they are not life-threatening, they cause significant morbidity, increase healthcare costs, and in some patients cause a progressive loss in lung function [5]. Key outcomes such as hospital admissions and mortality have not really improved in the past 10–15 years despite escalating pharmacological costs both financially and environmentally [6].

Historically, asthma has been managed with a stepwise approach which involves varying doses of inhaled corticosteroids (ICS) depending on the severity of symptoms with a short-acting β₂-agonist (SABA) as required across all stages [7]. However, studies have shown that overuse of SABA is associated with an increase in the frequency of asthma exacerbations, airway inflammation, and mortality [1, 8, 9]. Furthermore, SABA has been shown to have a high carbon footprint contributing to global warming, with a 100-dose Ventolin inhaler amounting to 28 kg of carbon dioxide [10]. Hence, the latest Global Initiative for Asthma (GINA) report no longer recommends SABA-only therapy [1].

The use of a single inhaler containing ICS and formoterol (FORM) for both maintenance and quick relief therapy maintenance and reliever therapy (MART) is recommended by GINA in steps 3–5 [1]. ICS-FORM provides quick relief for asthma symptoms similar to that of SABA while reducing the risk of severe asthma exacerbations, at an overall lower ICS exposure. Given well known adverse effects of SABA overuse on asthma outcomes and the environment, and the update in GINA guidelines, it is important to determine whether MART therapy with the elimination of SABA is effective for controlling asthmatics.

During the period Jan 2020–Dec 2021, patients registered and coded with moderately severe asthma on long-acting beta-agonist (LABA)/ICS therapy at a single UK general practice site were invited to an initial asthma clinic appointment (n = 195). Inclusion and exclusion criteria are outlined in Table 1. In this observational, non-intervention study; the SABA strategy was discussed in detail, and consent was sought. A total of 101 patients agreed to a new strategy of MART + anti-inflammatory reliever (AIR), and the remaining 94 patients continued with MART + SABA inhalers.

Participants were reviewed at 3, 9, 12, and 24 months to assess their inhaler use, number of exacerbations, and hospital admissions. All hospital admissions were analysed from hospital records and confirmed with clinical coding. As this was an observational study there were no changes in routine asthma management. ICS doses were adjusted in response to the presence or absence of exacerbations in accordance with routine asthma care. Participants continued to have annual asthma reviews where inhaler technique and adherence were assessed.

The sample size had a power of 85 and an alpha two-sided of 0.05 to detect a difference between the two groups. For non-normal distribution data, the Mann-Whitney test was used and Fisher’s exact test for the comparison of categorical variables. The R programme was employed as statistical software.

This study complies with the Declaration of Helsinki [11]. The study was approved by the De Montfort University Institutional Review Board Faculty Research Ethics Committee (FREC/019-68). All participants consented to participate in the study with all data being anonymised to comply with data protection legislations.

A total of 195 asthmatic patients participated in the study. At the beginning of the study period, there was no significant difference between the group’s general characteristics (Table 2) including history of asthma, predicted forced expiratory volume in 1 second (FEV₁), FEV₁ change post-bronchodilator, poorly controlled asthmatics, and the use of rescue medication. However, there were significantly fewer participants in the SABA-free group that used regular ICS at the beginning of the trial period (p = 0.0497).

A total of 101 asthma patients aged 14–69 receiving budesonide (BUD)/FORM MART therapy without SABA over a 24-month period had a statistically significant reduction in asthma-related hospitalisations (p = 0.003) (Figure 1) and asthma exacerbations requiring oral corticosteroids (OCS) (p = 0.041) compared to 94 individuals taking MART/SABA (Figure 2). There were 26 asthma exacerbation episodes in the SABA group requiring OCS compared to only 5 exacerbations in the SABA-free group over the 24-month study period (Figure 2). There were a total of 12 asthma-related hospitalizations in the patients across both groups (11 in the SABA group vs. 1 in the SABA-free group) with no mortality recorded. A similar pattern was seen when visits to emergency/same-day emergency departments (Figure 1) with a total of 23 visits in the total cohort (19 in the SABA group vs. 4 in the SABA-free group).

Analysis of asthma medication used over the 2-year study period is shown in Table 3. The SABA-free group was prescribed significantly less BUD/FORM over the 24-month period compared to the MART/SABA group (p < 0.001). Interestingly, the SABA-free group on average requested 4.9 cannisters of BUD/FORM per year compared to the SABA group (7.68 cannisters/year; p = 0.00347). This equated to almost 50% less steroid use in total by the SABA-free group when compared to the SABA group. Of note, the SABA group requested an average of 6.48 cannisters of SABA per year.