A certain George made a comment on this blog about asthma patients complaining that they are having problems with their HFA inhalers. They state that their HFA inhalers do not work as well as their CFC inhalers. Check the multiple links he has below(under Comments in the Spring Tips) and get involved if you agree.I think it is equally important to point out that the evidence is there to show that the amount of albuterol delivered by the HFA and CFC inhalers are comparable. It may be worth checking the FDA's website on this for a balanced take on this case. Go to http://www.fda.gov/cder/mdi/albuterol.htm
Also worth mentioning from the FDA website is the following:
ReplyDeletehttp://www.fda.gov/cder/foi/nda/2001/20-983_Ventolin-HFA_medr_P1.pdf
These quotes taken directly from the new drug application for Ventolin HFA.
"In the multiple dose adolescent and adult studies, albuterol HFA showed a numerically smaller improvement in FEV1 than was seen with albuterol CFC"
"There was other evidence that the HFA formulation delivers a lower/less effective dose on a per acutation basis than the CFC product. In the single dose, dose ranging study in adults, and in the single dose methacholine challenge study in adults one and two acutations of albuterol CFC were statistically indistinguishable in terms of effect, whereas significant differences were seen between one and two acutations of albuterol HFA. Finally, the combined adolescent/adult studies showed that the HFA formulation had a longer median time to onset of effect(4.2-9.6 minutes versus 3.6-4.2 minutes), had a shorter duration of effect(1.55-3.30 hours versus 2.29 - 3.69 hours), and was associated with more albuterol 'back up' use than the CFC formulation."
"We note that in the two 12 week clinical trials in adolescents and adults, Ventolin HFA Inhalation Aerosol consistently showed a smaller effect size than Ventolin CFC Inhalation Aerosol"
"Because it is expected that many physicians will prescribe Ventolin HFA Inhalation Aerosol for patients who have previously used the CFC formulation, it would be appropriate to include some description of the relative effectiveness of these two formulations in the product label."
"Unfavorable changes in physical examinations were observed in the ears, nose, and throat category as follows: 8% placebo HFA; 13% albuterol HFA; and 5% albuterol CFC."
Good info George. Thanks.
ReplyDeleteMV