Implementation of a stepped anti-inflammatory reliever therapy intervention with budesonide-formoterol 160/4·5 mcg by Turbuhaler versus usual care for adults presenting during exacerbations of obstructive lung disease suggestive of asthma or chronic obstructive pulmonary disease in a resource-limited setting: an open-label, cluster randomised trial.

Summary

In a 52-week, open-label cluster RCT (n=3095) across 40 district facilities in Vietnam, a stepped budesonide–formoterol anti‑inflammatory reliever strategy reduced moderate/severe exacerbations (RR 0.79) and hospitalizations (RR 0.74) versus usual care, with similar mortality and serious adverse events. Effects were consistent irrespective of baseline eosinophils.

Key Findings

• Reduced moderate/severe exacerbations: 28.6% vs 36.0% (RR 0.794; p=0.03) over 12 months.
• Lower respiratory hospitalizations: 17.4% vs 24.1% (RR 0.737; p=0.05); mortality and grade 3–4 adverse events were similar.
• No significant interaction by baseline blood eosinophils, supporting broad applicability.

Clinical Implications

Adopting a simple stepped budesonide–formoterol reliever algorithm with periodic review can standardize care, reduce exacerbations, and lower hospital burden where diagnostic and medication access is limited.

Limitations

• Open-label design with potential performance bias and cluster-level contamination.
• Undifferentiated disease population; limited diagnostic phenotyping and lack of spirometric confirmation.

Future Directions

Cost-effectiveness analyses, implementation research across other LMICs, phenotyping to refine step assignment, and head-to-head comparisons with alternative simplified strategies.