SELECTED ARTICLES FROM THE RECENT LITERATURE 2008

5/21/2008

Results of the START Study After Its Full Five Year Course

Summary
The START Study has been ongoing now for about five years. It originally enrolled 7,241 patients, ages 5 to 66 years, with recent onset, mild persistent asthma. In the first three years of the study, patients were randomized to double-blind treatment with budesonide or placebo. During these three years, the physician caring for the patient had the option of adding "usual asthma therapy" to this treatment program. After this three year protocol was completed, all patients received two additional years of open-label treatment with budesonide.

The primary outcome variable of the double-blind phase was the time to first severe asthma related event. The double-blind phase, as noted, was followed by two years of open-label treatment. The primary outcome variable of the full five year study was the change from baseline in post-bronchodilator percent predicted FEV1. The secondary outcome variables were the change in pre-bronchodilator percent predicted FEV1, number of exacerbations, symptoms, and use of concomitant medication.

During the full five year study period, the post-bronchodilator percent predicted FEV1 decreased, irrespective of randomized therapy, by an average of 2.22%. In adults, however, there was a statistically significant treatment difference of 0.85% in favor of the budesonide treated group. During the full five year study, pre-bronchodilator percent predicted FEV1 increased, irrespective of randomized treatment during the double-blind phase.

The lack of differences between pulmonary function measures in the treated versus untreated group after five years was due to a rapid "catch up" in lung function presumably related to the introduction of inhaled corticosteroid therapy in the previously placebo-treated group. This was true when the group was viewed as a whole. However, in adults, nearly half the treatment effect of budesonide on lung function attained in the double-blind phase still remained at the end of the five year period.

Patients treated with inhaled budesonide in the double-blind phase had a significantly lower risk of asthma related exacerbations during the full five year study period. In addition, patients in the treatment group used less additional asthma medications in both the open-label and double-blind phases.

It was concluded in mild persistent asthma early intervention with inhaled budesonide was associated with improved asthma control and less additional asthma medication.

Reference
The Inhaled Steroid Treatment As Regular Therapy in Early Asthma (START) study 5-year follow-up: Effectiveness of early intervention with budesonide in mild persistent asthma , 14 April 2008 William W. Busse, Søren Pedersen, Romain A. Pauwels, Wan C. Tan, Yu-Zhi Chen, Carl Johan Lamm, Paul M. O'Byrne, START Investigators Group The Journal of Allergy and Clinical Immunology May 2008 (Vol. 121, Issue 5, Pages 1167-1174)

 

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