Chest
Volume 129, Issue 6, June 2006, Pages 1478-1485
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Original Research
Effects of Early Intervention With Inhaled Budesonide on Lung Function in Newly Diagnosed Asthma

https://doi.org/10.1378/chest.129.6.1478Get rights and content

Study objectives

Asthmatic patients lose lung function faster than normal subjects. The effectiveness of early intervention with inhaled corticosteroids on this decline in lung function is not established in recent-onset disease.

Design

The Inhaled Steroid Treatment as Regular Therapy in Early Asthma study was a randomized, double-blind study in 7,165 patients (5 to 66 years old), with persistent asthma for < 2 years to determine whether early intervention with low-dose inhaled budesonide prevents severe asthma-related events and the decline in lung function. Patients received budesonide (200 μg qd for children < 11 years old and 400 μg qd for others) or placebo for 3 years in addition to usual asthma medications.

Results

Treatment with budesonide significantly improved prebronchodilator and postbronchodilator FEV1 percentage of predicted and reduced the mean declines from baseline for postbronchodilator FEV1 at 1 year and 3 years: – 0.62% and – 1.79% for budesonide and – 2.11% and – 2.68% for placebo, respectively (p < 0.001). The decline was more marked for male patients, active smokers, and patients > 18 years old, and the smallest treatment effects were in adolescents.

Conclusions

Long-term, once-daily treatment with low-dose budesonide improved both prebronchodilator and postbronchodilator FEV1 in patients with recent-onset, persistent asthma, and reduced the loss of lung function over time.

Section snippets

Materials and Methods

The study design, methods, and inclusion and exclusion criteria of the START trial are described in detail elsewhere.10 The study enrolled 7,241 patients aged 5 to 66 years from 32 countries. Patients had asthma symptoms weekly, but not daily, during the 3 months prior to study. These symptoms had to be present for < 2 years (ideally < 1 year). Patients demonstrated airway obstruction by an increase in FEV1 > 12% after a β2-agonist, a fall in FEV1 > 15% after exercise, or a variation > 15% in

Results

Of the 7,241 patients that entered the study, 7,165 were available for analysis, of whom 3,597 were randomized to budesonide and 3,568 to placebo. From this cohort, 2,010 patients did not complete the 3 years of double-blind treatment. The dropout rate (27.5% in the budesonide group and 28.6% in the placebo group) and the mean time in the study (2.47 years in the budesonide group and 2.44 years in the placebo group) were comparable for the two treatment arms. There were 3,419 patients in the

Discussion

This study is the first large, prospective evaluation of the effects of early intervention with inhaled corticosteroids on asthma progression, as determined by the development of severe asthma-related events and changes in lung function. In this study, average duration of time since asthma diagnosis was < 1 year. The study demonstrated that treatment with low doses of inhaled budesonide improved both prebronchodilator and postbronchodilator FEV1, and this effect persisted over the 3 years of

Safety Committee

A. Sheffer (Boston, MA [Chairman]); A. Woolcock (Sydney, Australia); P. Diaz (Santiago, Chile); M. Silverman (Leicester, UK); B. Lindmark (Lund, Sweden [nonvoting member]).

Western and Central Europe

Austria (n = 88 patients recruited): Josef Eckmayr, Josef Riedler, Gert Wurzinger, Günter Ott, Jasminka Zarkovic, Andrea Schulheim, Manfred Götz, Herwig Schinko, Ingrid Thomüller; Belgium (n = 223): Wilfried de Backer, Hugo van Bever, Geert Verleden, Christiane de Boeck, Joseph Aumann, Walter Vincken, Isidor Dab, Paul de

References (26)

  • BrownPJ et al.

    Asthma and irreversible airflow obstruction

    Thorax

    (1984)
  • CassinoC et al.

    Duration of asthma and physiologic outcomes in elderly nonsmokers

    Am J Respir Crit Care Med

    (2000)
  • HaahtelaT et al.

    Effects of reducing or discontinuing inhaled budesonide in patients with mild asthma

    N Engl J Med

    (1994)
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    Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml)

    This study was funded by AstraZeneca R&D, Lund, Sweden.

    †Dr. Pauwels died in January 2005.

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