Over 7,000 patients from 32 countries and ranging in age from 5 to 66 years participated in the study over three years. All persons were defined as having mild asthma of at least 3 months but of less than 2 years duration. Mild asthma was defined as typical symptoms (wheezing, coughing, tight chest, shortness of breath) at least weekly but less often than daily. Patients received modest doses of budesonide (the inhaled cortisone) or placebo, in addition to other asthma medications as necessary in the course of routine treatment. Budesonide is available in the U.S. under the brand name Pulmicort. Kids age ten years and younger received one puff daily, and everyone older than ten received two puffs daily.

Clinical studies generally designate a single characteristic or "outcome variable" that will be the major endpoint that is measured in the study. In this lengthy trial the primary outcome was the time to first severe asthma-related event, defined as one which required hospital admission or emergency treatment or as death due to asthma.

The study showed that persons taking the inhaled steroid experienced far fewer asthma attacks resulting in hospitalization or emergency visits. Life-threatening asthma attacks were almost three times as likely in the placebo group. Those receiving the inhaled steroid also had more total days without any symptoms and needed less albuterol and prednisone bursts. Lung function as measured by spirometry was better in the steroid-treated group.

In children under 11 years of age, there was an approximate half inch decrease in growth over the three-year study period

CONCLUSIONS

Long-term, low-dose inhaled steroid therapy with budesonide markedly reduces the risk of asthma flares and day-to-day asthma symptoms in persons of all ages with asthma of recent onset, even when the asthma was relatively mild.

DR. BANKS' COMMENTS

We have known for a long time that inhaled corticosteroids are the most effective medicines we have in the management of chronic asthma, and the evidence has been most obvious in those with moderately severe disease (what we call "moderate persistent asthma") and severe asthma. The START study will prove to be a landmark for treatment of those with somewhat less severe disease, as it shows compelling benefit in asthma control for people with less severe disease when treatment begins soon after diagnosis. A very important question remains unanswered--and is a very hot topic in our specialty. Does early treatment with inhaled steroid medicine alter the natural history of asthma? In other words, are you less likely to be asthmatic ten or twenty years down the road because you were treated with inhaled steroid soon after you developed the condition? We simply don't know the answer to that question at this time, but my personal bias is "no," based on the studies published to date and our practical real world experience. That should not detract at all from the key messages from the START study: Take your inhaled corticosteroid spray regularly and significantly reduce your chances of landing in the ER or hospitalized, in addition to improving your day-to-day asthma quality of life!! This holds even for those folks at the relatively mild end of the asthma severity spectrum, those who might not have ever experienced a memorable attack at the time of diagnosis BUT who clearly are at risk of such attacks.

Parents are understandably anxious when they hear about the potential for growth delay when inhaled cortisones are used. A study recently published in The New England Journal of Medicine showed that children using 1-2 puffs of budesonide daily for ten years reached normal adult height. Some degree of catch-up growth goes on, even with continued use of the medicine apparently. We are NOT turning out a bunch of short kids by having used inhaled cortisones for the past 25 years. Growth should be regularly monitored, and the lowest inhaled cortisone dose required to control symptoms should always be the goal. Remember, side effects from the disease are vastly worse than side effects from the treatment! There is no reason to think that one inhaled cortisone product would be superior to another in terms of providing the protection described in the START study with budesonide. Other brands available in the U.S. include Azmacort, Flovent, AeroBid, and Advair (the latter is a combination of the cortisone found in Flovent combined with a long-acting bronchodilator).