Although the FDA is somewhat limited in making recommendations about various therapeutic options, Kemp said it was clear that the agency viewed intranasal and orally inhaled corticosteroids as extremely useful medications in the management of allergic rhinitis and asthma. The divisions, in turn, will determine the appropriate next steps. The FDA spokesperson said there is no specific timetable for this process. Additional information will be published in Academy News as it becomes available. As has been recommended in the asthma management guidelines, once control has been obtained with corticosteroids, then a step-down approach to a lower dose is indicated.
Measurements taken from stadiometers are likely to be consistent and extremely accurate.
On the first day, the committees discussed the impact of orally inhaled and intranasal corticosteroids on growth in children, heard from invited experts regarding the process of normal growth and development in children and how various factors including corticosteroids may impact it, and reviewed examples from industry of completed growth studies testing the various inhaled and intranasal corticosteroid drug products. During the second day of the meeting, the agency presented the proposed class labeling for inhaled and intranasal corticosteroid drug products, reviewed the data that supported it, and led a general scientific discussion among all meeting participants to reach a consensus concerning appropriate labeling for these products and recommendations for the design and conduct of future clinical trials that assess growth. The following is the text of his presentation. Therefore, the discussion and decisions that will be forthcoming during this meeting will impact our profession and our patients more than any other group. Asthma and allergies such as allergic rhinitis affect 10 percent to 20 percent of the population.