Efficacy and Safety of Budesonide Formoterol MART vs Fixed-dose Fluticasone Salmeterol in COPD

Efficacy and Safety of Budesonide/Formoterol MART vs Fixed-dose Fluticasone/Salmeterol in COPD

17 Apr, 23

Introduction

Symptom-driven maintenance and reliever therapy (MART) with inhaled corticosteroid (ICS)/formoterol is known to effectively reduce exacerbations in asthma, at a lower cumulative ICS dose. However, the efficacy and safety of ICS/formoterol MART have not been studied in patients with chronic obstructive pulmonary disease (COPD).

Aim

To compare the efficacy and safety of budesonide/formoterol MART (Bud/Form) versus fixed-dose fluticasone/salmeterol combination (FSC) in patients with moderate to severe COPD.

Method

Study Design

Open-label, parallel-group, randomized, 52-week, multicenter study

Patient Profile

Adults aged between 40 to 80 years with a clinical diagnosis of COPD

Postbronchodilator forced expiratory volume in 1 sec (FEV1) <80% predicted
Current or ex-smokers with smoking history of atleast 10 pack-years
History of atleast 1 COPD exacerbation in last 2 years

Treatment Strategy

The overall cohort of 195 patients was randomized to receive either MART or fixed-dose therapy

A total of 103 patients received MART Bud/Form 160/4.5 µg 2 inhalations twice daily+additional inhalations as needed and 92 patients received FSC 500/50 µg 1 inhalation twice daily+salbutamol 100 µg as needed for 52 weeks
Baseline characteristics of both the groups were comparable except for a higher proportion of males in FSC group (79.4% vs 61.2%)

Endpoints

Primary Endpoint

Rate of moderate/severe exacerbations

Secondary Endpoints

Total ICS dose per day
Changes in lung function parameters from baseline
Change in health status scores from baseline

Safety Endpoints

Incidence of adverse events (AEs)
Incidence of serious AEs (SAEs)
Incidence of pneumonia

Results

There was no significant difference in moderate/severe exacerbation rates between MART and FSC groups (1.32 vs 1.32 /year, respectively, rate ratio 1.05; p=0.741).

The rates of moderate and severe exacerbation and time to first moderate or severe exacerbation was also similar
The median time to first exacerbation was 211 days in MART and 195 days in FSC
Total ICS dose was significantly lower with MART than FSC therapy; p<0.05

Figure 1. Total ICS Dose

Changes in lung function parameters and in health status scores from baseline were similar in both treatment arms
The safety profile of both the therapies was similar as seen in Figure 2.

Figure 2. Incidence of AEs and SAEs

Pneumonia was reported by 5 and 1 patient in the MART and FSC groups respectively; p=0.216.

Conclusion

Maintenance and reliever therapy (MART) with budesonide/formoterol was equally effective and safe as fixed-dose fluticasone/salmeterol combination (FSC) therapy in patients with moderate to severe COPD
Budesonide/formoterol MART therapy resulted in a significantly lower dose of inhaled corticosteroids than FSC and can be a successful treatment strategy in moderate to severe COPD

Thorax. 2023 Feb 1;thorax-2022-219620. Doi: 10.1136/thorax-2022-219620.