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Early intervention with budesonide in mild persistent asthma: a randomised, double-blind trial
Romain A Pauwels1, Søren Pedersen, William W Busse
1Department of Respiratory Diseases, Ghent University Hospital, Ghent, Belgium. romain.pauwels@rug.ac.be <romain.pauwels@rug.ac.be>
Lancet (London, England)
|April 4, 2003
Summary
Low-dose budesonide significantly reduced severe asthma exacerbations in recent-onset mild persistent asthma. This treatment also improved asthma control and lung function over three years.
Area of Science:
- Pulmonology
- Clinical Trials
- Pharmacology
Background:
- Inhaled glucocorticosteroids are standard for persistent asthma.
- Long-term efficacy in recent-onset, mild persistent asthma remains under-evaluated.
Purpose of the Study:
- To evaluate the long-term effects of budesonide in mild persistent asthma of recent onset.
- To assess budesonide's impact on severe exacerbations and asthma control.
Main Methods:
- Randomized, double-blind, placebo-controlled trial involving 7241 patients across 32 countries.
- Patients received daily budesonide (400 mcg or 200 mcg for children <11 years) or placebo for 3 years.
- Primary outcome: time to first severe asthma-related event; intention-to-treat analysis.
Main Results:
- Budesonide significantly reduced severe asthma exacerbations (HR 0.56, p<0.0001).
- Patients on budesonide experienced fewer systemic corticosteroid courses and more symptom-free days.
- Budesonide improved lung function (FEV1) and showed consistent effects regardless of baseline parameters.
- A slight reduction in growth was observed in children under 11.
Conclusions:
- Once-daily, low-dose budesonide is effective for mild persistent asthma of recent onset.
- Treatment decreases severe exacerbation risk and enhances overall asthma control.
- Potential growth effects in children warrant consideration.
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