Bisgaard regime
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PMID: 16687712
Now I have a clear picture. Here is a thorough answer:
The Bisgaard Regime
The Bisgaard regime refers to a treatment strategy for episodic viral wheeze (EVW) in infants and young children, named after Danish pediatric pulmonologist Prof. Hans Bisgaard of the Copenhagen Prospective Studies on Asthma in Childhood (COPSAC). It consists of intermittent, parent-initiated inhaled corticosteroid (ICS) therapy given in short courses triggered by the onset of wheezing episodes, rather than as continuous daily preventive therapy.
The Protocol
The core regimen studied by Bisgaard involves:
- Drug: Inhaled budesonide 400 mcg/day (via spacer/nebulizer)
- Trigger: Started by the parent at home after a child has had 3 days of wheezing
- Duration: Given for a 2-week course per episode
- Patient group: Infants from ~1 month of age with recurrent episodic wheeze
The rationale was that episodic viral wheeze in early life may represent a pre-asthmatic state, and that treating each episode aggressively with ICS might reduce symptom burden and delay or prevent progression to persistent asthma.
Key Trial (NEJM 2006)
The landmark RCT by Bisgaard et al. (NEJM, 2006) (PMID: 16687712) tested this approach in 411 infants randomized from 1 month of age, followed for 3 years:
- Primary outcome: Proportion of symptom-free days - no significant difference (83% budesonide vs. 82% placebo)
- Secondary outcome: Progression to persistent wheezing - no significant benefit (24% budesonide vs. 21% placebo; HR 1.22, 95% CI 0.71-2.13)
- Safety: No significant effect on height or bone mineral density
- Episode duration: ~10 days in both groups regardless of respiratory viral status
Conclusion: Intermittent ICS therapy (the Bisgaard regime) had no effect on progression from episodic to persistent wheezing and no short-term symptomatic benefit during episodes in the first 3 years of life.
Context and Significance
| Feature | Detail |
|---|---|
| Population | Infants, from ~1 month, with recurrent episodic wheeze |
| Phenotype targeted | Episodic viral wheeze (EVW), not multitrigger wheeze |
| Drug | Inhaled budesonide 400 mcg/day |
| Mode | Intermittent (on-demand per episode), not continuous |
| Duration per course | 2 weeks |
| Outcome | No benefit over placebo in this RCT |
Clinical Implications
Despite the negative result of the original trial, the "Bisgaard regime" concept remains widely discussed in pediatric respiratory medicine because:
- It clarified phenotypes - children with pure episodic viral wheeze likely do not benefit from ICS the way children with multitrigger or atopic wheeze might.
- It validated parental action plans - the idea of parent-initiated therapy at symptom onset (a "rescue" ICS approach) is used in some guidelines for older preschool children, though evidence remains mixed.
- Subgroup considerations - some later analyses suggest children with atopic features or high-risk profiles may respond differently.
Current guidelines (ERS, GINA) do not universally recommend this approach for all preschool wheezers, but it informs individualized management discussions, particularly for children with clear viral-trigger-only wheeze vs. atopic/multitrigger disease.
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