While I agree that the package insert cannot support better clinical efficacy related to better lung deposition (from an FDA perspective) there are certainlly several deposition studies which do strongly support better deposition (Several articles by Leach, etal, starting with paper in ERJ in 1998). It is highly likely that deposition in mild asthma makes very little difference. The disease tends to be more central, and even very low levels of ICS can improve symptoms and FEV1. The deposition issue is likely to be more important in severe asthma. Deposition studies have shown that particles distribution is dependent on level of obstruction, with less peripheral deposition in general, with increasing obstruction. Unfortunately, the right clinical trial, comparing deposition and efficacy in severe asthma has never been done, hence, the FDA making certain the company does not claim a difference. The small clinical trial that I referred to was indeed published in the Journal of Asthma in 2005, with Dr. Harold Nelson as senior author. Yes, it is a small pilot study, but the results are in fact intriguing, with HFA-beclomethasone added in very similar quantity to the increase in CFC fluticasone giving a more robust increase in measures of small airway function. A large scale clinical trial should be done in patients with more severe asthma, where the deposition MIGHT matter more. The new AsthmaNet network would be a perfect place to do that trial. In the meantime, as someone who sees alot of these very severely obstructed patients, I will continue to "anecdotally" report that in perhaps 30-40% of people, the addition of 160-320 mcg of HFA-beclomethasone to combination therapy, makes a difference in clinically relevant outcomes, including need for oral steroids. This effect "appears" to be different from just increasing the fluticasone. Although the large scale randomized clinical trial must be done, these severe asthmatic patients currently have almost no additional therapeutic options available. HFA-beclomethasone is both reasonably inexpensive (compared to anti-IgE for instance), safe (compared to oral steroids)and has the potential to improve outcomes. I believe it is worth a try. By the way, I am not in any way conflicted with the company that makes HFA-beclomethasone.