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Early Steroid Treatment Maintains Lung Function in Asthma Patients: Presented at ACAAI

By Roberta Friedman
Special to DG News

SAN ANTONIO, TX -- November 15, 2002 -- Early use of inhaled steroids staves off the decline in respiratory function seen with asthma, suggest findings from a multinational trial presented at a symposium here today.

Starting inhaled steroids early also avoids hospital stays for exacerbations of mild, persistent asthma, researchers with the Steroid Treatment as Regular Therapy (START) trial reported at the meeting of the American College of Allergy, Asthma & Immunology.

Budesonide lowered the hazard rate of severe exacerbations of asthma by 44 percent, researchers reported.

The START study tested the "real life" use of budesonide around the world. It recruited more than 7000 patients in 32 countries. Doctors were allowed to use any therapy they judged necessary, as well as the study drugs, to keep asthma under control. The trial randomized patients to inhaled budesonide or placebo.

The power of the large trial allowed the investigators to find statistically significant differences between the two groups. Forced expiratory volume in one second (FEV₁) before bronchodilator use, was reduced less in the budesonide group. As a percent of predicted value, FEV₁ declined with budesonide use by 0.62 percent and by 1.79 percent at year one and three of the trial, compared to 2.11 percent and 2.68 percent respectively for the group assigned to placebo.

Teens did not show the improvement, but also did not show the decline in FEV₁. "This is a new finding," said study investigator Soren Pedersen, MD, PhD. "We don't know how to interpret it."

Study patients were entered into the trial after only a year or two following their diagnosis of mild, persistent asthma. Symptoms had to include wheeze, cough, dyspnea, and night awakenings due to these. The study recruited patients from 1996 to 1998. Assignment was to once daily, single inhalation from a dry powder inhaler in addition to a patients' usual asthma treatments.

Dose of budesonide was 200 micrograms daily for children less than 11 years, and 400 micrograms for other patients. Primary outcome was time to first severe event due to asthma: hospitalisation or emergency room visit required. Death due to asthma was also scored as part of this outcome measure.

Growth rate of children in the budesonide group was slowed, but by a half a centimeter or less, for each of the three years of the trial. A study with less statistical power might have failed to pick up this small effect, said Dr. Pedersen, professor of respiratory medicine at both the University of Southern Denmark in Odense, Denmark, and McMaster University in Canada.

Dr. Pedersen said that the effect on eventual adult height of inhaled steroid use is negligible, according to the evidence of trials conducted to date. Children tend to catch up in their growth rate after the third year of a study. "Growth is less inhibited in START than in other studies," Dr. Pedersen said.

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