Study finds no clinical advantage of budesonide inhaler over fluticasone in COPD

By Dr. Chinta SidharthanReviewed by Danielle Ellis, B.Sc.Jan 6 2025

The researchers evaluated budesonide-glycopyrrolate-formoterol and fluticasone-umeclidinium-vilanterol in preventing COPD exacerbations and pneumonia hospitalizations in real-world settings. They provided evidence to guide treatment decisions for COPD patients.

In a recent study published in BMJ, a team of researchers from the United States (US) and Canada investigated the comparative effectiveness and safety of two single-inhaler triple therapies for chronic obstructive pulmonary disease (COPD).

Background

Chronic obstructive pulmonary disease (COPD) is a progressive respiratory condition marked by limitations to airflow and exacerbations that worsen the quality of life of the patients and increase the healthcare burden.

Triple inhaler therapy, which combines an inhaled corticosteroid with a long-acting beta-agonist and a long-acting muscarinic antagonist, has been recommended for certain patients to manage symptoms and prevent exacerbations. While randomized trials have shown the benefits of individual triple therapy components, direct comparisons of combinations of these three components in different formulations remain limited.

Observational studies have indicated that fluticasone-based treatments may be associated with higher pneumonia risk but fewer exacerbations compared to budesonide-based options. However, these studies often lack direct comparisons, involve varying definitions of symptoms and outcomes, and focus only on selected populations.

Additionally, concerns about the environmental impact of metered-dose inhalers also necessitate evaluating alternatives such as dry powder inhalers. Therefore, comprehensive real-world evidence is essential to guide clinical and environmental decision-making for COPD management.

About the study

In the present cohort study, the researchers compared the effectiveness and safety of two single-inhaler triple therapies for COPD — budesonide-glycopyrrolate-formoterol (administered twice daily through metered-dose inhalers) and fluticasone-umeclidinium-vilanterol (administered once daily using dry powder inhaler) — using real-world data from the US health claims from 2021 to 2023.

The study included participants aged 40 years and older with a valid COPD diagnosis who were new users of either therapy. Patients with prior triple therapy exposure, concurrent inhalers, or incomplete baseline data were excluded.

The primary outcomes examined in the study were the first moderate or severe exacerbation of COPD symptoms, which indicated the effectiveness of the therapy, and the first hospitalization due to pneumonia, which was indicative of the safety of the inhaler therapy.

Moderate exacerbations were defined as those requiring short courses of systemic steroids, while severe exacerbations were classified as those that resulted in hospitalizations. Additionally, hospital admissions with pneumonia were identified through diagnostic codes. The patients were followed for up to one year or until treatment discontinuation or switching, outcome occurrence, or loss to follow-up.

Major findings

The researchers found that dry powder triple inhaler therapy of fluticasone-umeclidinium-vilanterol resulted in fewer COPD exacerbations compared to metered dose triple inhaler therapy of budesonide-glycopyrrolate-formoterol. Among the 20,388 matched pairs, the hazard of a moderate or severe exacerbation was 9% higher for budesonide-glycopyrrolate-formoterol users (hazard ratio 1.09).

Although moderate exacerbations were 7% more likely and severe exacerbations were 29% more frequent with budesonide-glycopyrrolate-formoterol usage, the rate of hospitalization for pneumonia was identical between the two therapies (hazard ratio 1.00).

Furthermore, the results from the subgroup analysis also showed greater risks with budesonide-glycopyrrolate-formoterol in patients with prior exacerbations, severe disease, or elevated eosinophil counts. Still, patients without these risk factors exhibited fewer differences.

The sensitivity analyses, which varied follow-up time and exacerbation definitions, also confirmed the primary results. However, both therapies showed similar rates of all-cause mortality.

These findings suggested that fluticasone-umeclidinium-vilanterol triple inhaler therapy had a slight advantage in reducing exacerbations without any additional pneumonia risk. This also aligned with its potential environmental benefits due to its dry powder formulation.

Conclusions

To summarize, the study reported that fluticasone-umeclidinium-vilanterol triple inhaler therapy demonstrated a slight clinical advantage in preventing COPD exacerbations without increasing the risk of adverse events such as pneumonia. These findings highlighted the importance of evaluating both clinical outcomes and environmental impacts when selecting inhaler therapies for COPD.

The results also supported the use of dry powder inhalers such as fluticasone-umeclidinium-vilanterol as effective alternatives to metered-dose inhalers. These findings also conformed with current healthcare efforts to reduce greenhouse gas emissions while maintaining patient care standards.