Introduction:
Inhaled corticosteroid/long-acting β₂-agonist combinations (ICS/LABA), such as budesonide/formoterol (BUD/FORM), not only relieve symptoms but also reduce inflammation. This study aimed to evaluate the day-to-day relationship between airway inflammation, symptoms, lung function, and reliever use in adults on BUD/FORM maintenance therapy using either salbutamol or BUD/FORM as a reliever.
Methods:
- Study Design: Open-label, multi-centre, Phase 4 randomized controlled trial (NCT03924635).
- Participants: 42 adults (≥18 years) with an asthma diagnosis for ≥6 months, already on ICS/LABA for ≥3 months, and had experienced at least one episode of symptom worsening with reliever overuse beyond their usual pattern in the past 30 days.
- Intervention:
- Group 1: BUD/FORM as maintenance + BUD/FORM as reliever (Anti-Inflammatory Reliever - AIR) (n=18)
- Group 2: BUD/FORM maintenance + Salbutamol reliever (n=24)
- Duration: 24 weeks
- Daily Monitoring:
- FeNO (airway inflammation marker)
- Total asthma symptom score
- Peak Expiratory Flow (PEF)
- FEV₁
- Reliever use (tracked via smartphone-connected devices)
- Outcomes:
- Severe exacerbations (event requiring ≥3 days of oral corticosteroids, urgent care, or emergency room visit resulting in systemic corticosteroids, or an inpatient hospitalization for asthma)
- Composite Exacerbation Index (CompEx; severe exacerbation or diary-based event including worsening PEF, increased reliever use, worsening symptoms, and awakenings based on an established algorithm)
- Days with ≥6 reliever uses
- Safety via adverse events (AEs)
Results:
|
Outcome |
BUD/FORM AIR (n=18) |
Salbutamol (n=24) |
|
Severe exacerbations (≥1) |
11.1% (2 patients) |
29.2% (7 patients) |
|
CompEx events (≥1) |
22.2% (4 patients) |
50.0% (12 patients) |
|
Days with ≥6 reliever uses (≥1 day) |
16.7% (3 patients) |
37.5% (9 patients) |
|
FeNO, symptom scores, PEF, FEV₁ |
Lower day-to-day variation |
Higher variation |
|
Adverse Events |
0 |
1 serious AE reported |
Conclusion:
Using BUD/FORM as AIR led to reduced airway inflammation variability and fewer acute asthma-related events compared to salbutamol reliever. These findings support BUD/FORM AIR's anti-inflammatory benefits. Further research is needed to explore patterns around acute exacerbation events.
Am J Respir Crit Care Med 2025; 211: A1289
American Thoracic Society 2025 International Conference, May 18-21, San Francisco
