The NIH study, known as The Childhood Asthma Management Program (CAMP), is the largest and most comprehensive trial ever conducted in the U.S. for the treatment of childhood asthma. The multi-centre, randomised, double-blind clinical trial, involved over 1,000 asthmatic children, aged 5 to 12 years, for a treatment period up to six years. The Danish study, conducted by Drs. Lone Agertoft and Soren Pedersen, is the longest trial of its kind worldwide. To date, this prospective-controlled study has followed 142 children treated daily with inhaled budesonide for an average of 9.2 years.

The NIH/CAMP study evaluated safety and efficacy in children with mild to moderate asthma. Three treatment groups were studied -- one group received an inhaled corticosteroid, Pulmicort Turbuhalerâ (budesonide), another group, an inhaled non-steroid, nedocromil, and a third group, a placebo (symptomatic treatment only). All children used albuterol for asthma symptoms.

Overall, the NIH/CAMP study demonstrated that daily use of inhaled budesonide helped control asthma better than nedocromil or symptomatic treatment. As compared with children treated symptomatically, the budesonide group had a 43% lower rate of hospitalisations, a 45% lower rate of urgent care visits, and a 43 % lower rate of use of prednisone courses.

According to the authors, "control of asthma was best in the budesonide group, as indicated by significantly fewer symptoms, less use of albuterol for symptoms and more episode-free days." Across all groups there was no difference in lung function, the primary variable. A 1.1 cm difference in height in patients in the budesonide vs placebo-group was seen within the first year, but did not progress. At the end of the study, height velocity was similar to placebo and the projected final height was also expected to be similar to placebo.

It has long been debated whether long-term treatment with an inhaled corticosteroid would affect final height. In the Agertoft/Pedersen study, it was found that children reached their final expected height even after an average of 9.2 years (range 3 to 13 years) of long-term treatment with inhaled budesonide. Noted Lone Agertoft, MD, "Over the past decade a great deal of research has been put into evaluating the efficacy and safety of the different inhaled corticosteroids in asthma. These new data are an important piece of evidence in the debate about the influence of inhaled budesonide on growth," Added Soren Pedersen, MD, "Our study shows that children with asthma can receive the benefits of long-term inhaled budesonide and still grow to the height we would normally expect them to reach."

According to the 1997 NIH asthma guidelines, the potential risks of inhaled corticosteroids are well balanced by their benefits. In terms of growth, the guidelines note that growth rates are highly variable and that poorly controlled asthma itself may delay growth in children  [1].

AstraZeneca provides a range of products for the treatment of respiratory diseases^*. The largest in terms of sales is Pulmicort Turbuhaler®, Europe's best selling asthma drug^**. Pulmicort Turbuhaler® (budesonide inhalation powder) and Pulmicort Respules® (budesonide inhalation suspension) are second generation inhaled corticosteroids used to help prevent symptoms and improve control of asthma.