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Effects of Early Intervention With Inhaled Budesonide on Lung Function in Newly Diagnosed Asthma^*

Paul M. O’Byrne, MD, FCCP; Søren Pedersen, MD; William W. Busse, MD; Wan C. Tan, MD, FCCP; Yu-Zhi Chen, MD; Stefan V. Ohlsson, PhD; Anders Ullman, MD; Carl Johan Lamm, PhD and Romain A. Pauwels, MD, FCCP

^* From the Department of Medicine (Dr. O’Byrne), McMaster University, Hamilton, ON, Canada; Department of Pediatrics (Dr. Pedersen), Kolding Hospital, University of Odense, Kolding, Denmark; University of Wisconsin (Dr. Busse), Madison, WI; National University of Singapore (Dr. Tan), Singapore; Capital Institute of Pediatrics (Dr. Chen), Beijing, People’s Republic of China; AstraZeneca R&D (Drs. Ohlsson, Lamm, and Ullman), Lund, Sweden; and Department of Respiratory Diseases (Dr. Pauwels), Ghent University Hospital, Ghent, Belgium; on behalf of the START Investigators Group.

Correspondence to: Paul O’Byrne, MD, FCCP, Department of Medicine, McMaster University Medical Center, 1200 Main St West, Hamilton, ON, Canada; e-mail: obyrnep{at}mcmaster.ca

Abstract

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.

Key Words: asthma • early intervention • inhaled corticosteroids • lung function

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