The inhaled Steroid Treatment As Regular Therapy in early asthma (START) study: Rationale and design

Although the beneficial effects of treatment with inhaled steroids in asthm a are widely accepted, the role of early intervention in patients with mild asthma remains unsettled. Conventional efficacy trials are often of short duration and involve highly selected patient populations that exclude many patients typical of those encountered in routine clinical practice. Hence, a large "real-world" effectiveness study is needed to evaluate the benefits of early intervention with inhaled steroids in patients with mild, persist ent asthma. In the START inhaled Steroid Treatment As Regular Therapy in ea rly asthma) study, patients ages 6-60 years, from 31 countries and district s worldwide with mild persistent asthma, have been randomized to once-daily treatment with budesonide, 200 mug (for patients < 11 years) or 400 mug (f or patients greater than or equal to 11 years), or placebo via Turbuhaler(( R)) for 3 years. The double-blind treatment period will be followed by a 2- year period of open budesonide treatment. Throughout the study, other asthm a medication including glucocorticosteroids can be given as judged appropri ate by the investigator. Lung function will be measured by spirometry using standardized techniques at 3-month intervals throughout the study, and bro nchodilator reversibility will be measured annually. The primary outcome me asures are the time to the first severe asthma-related event during the fir st 3 years of the study and the change in postbronchodilator forced expirat ory volume in 1 second (FEV1) from baseline during the entire 5-year study period. These measures have been chosen to reflect the progression of mild asthma toward more severe asthma and the extent of irreversible airflow lim itation, which should reflect the degree of airway remodeling. (C) Elsevier Science Inc. 2001.