- Design
- post hoc analysis of two multicentre randomised controlled trials, stratified by baseline symptom burden
- Population
- 224 patients with bronchiectasis in SAVE-BE (florensocatib) and 357 in TORNASOL (inhaled tobramycin)
- Primary outcome
- association between baseline QoL-B Respiratory Symptom Scale and treatment effect
- Effect
- florensocatib exacerbation RR 0.47 (95% CI 0.33-0.67) overall, no significant symptom improvement; tobramycin symptom improvement exceeding the 8-point threshold in high-symptom patients
A post hoc analysis of two randomised trials asked whether baseline symptom burden, measured on the Quality of Life-Bronchiectasis Respiratory Symptom Scale, predicts who responds to what. SAVE-BE (n = 224) tested florensocatib, a DPP-1 inhibitor acting on neutrophil serine proteases; TORNASOL (n = 357) tested inhaled tobramycin.
The two behaved differently. Florensocatib cut exacerbations against placebo (RR 0.47, 95% CI 0.33-0.67), with relative risks of 0.53 in high-symptom and 0.40 in low-symptom patients, but produced no significant symptomatic improvement in either. Tobramycin improved symptom scores by a clinically meaningful margin — above the 8-point threshold in high-symptom patients — and reduced bronchitic symptoms, with greater benefit the more symptomatic the patient was at baseline.
The suggested rule is that anti-inflammatory therapy prevents events while anti-infective therapy relieves symptoms, and that a simple questionnaire score might indicate which the patient in front of you needs. It is a hypothesis drawn from two separate trials analysed after the fact, not a comparison — the two drugs were never tested against each other. But the score is free, takes minutes, and is worth recording now so that the question can be asked properly later.
- Record a symptom score at baseline in bronchiectasis; it costs nothing and may become a stratification tool
- Do not expect a DPP-1 inhibitor to make the patient feel better — it reduced exacerbations without improving symptoms
- The two drugs were tested in separate trials; this is not a head-to-head comparison
- Exacerbation frequency and symptom burden are different problems and may need different answers
- Inhaled tobramycin availability and cost vary widely in Indian practice; confirm before raising it
Why it matters
It raises the possibility that a free questionnaire, not a biomarker, separates who needs an anti-inflammatory from who needs an antibiotic.
Don't overread it
Post hoc subgroup analysis across two unrelated trials — no direct comparison was made and none of this is confirmatory.
The statistics, in plain English
Comparing subgroup relative risks across two different trials is not a statistical comparison, and the authors call the findings hypothesis-generating for exactly that reason. The 8-point threshold on the symptom scale is what patients can perceive; tobramycin crossed it in the high-symptom group, meaning the improvement was noticeable rather than merely measurable.
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