01 Sep Long-Acting Beta-Agonists-Steroid Combination in Pediatric Asthma
MedicalResearch.com Interview with:
David A Stempel, MD
Medical Affairs Lead
US Medical Affairs
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Long-acting beta-agonists (LABAs) have been shown to increase the risk of asthma-related death among adults and the risk of asthma-related hospitalization among children.
It is unknown whether the concomitant use of inhaled glucocorticoids
with LABAs mitigates those risks. This trial prospectively evaluated the safety of the LABA salmeterol, added to fluticasone propionate, in a fixed-dose combination in children.
MedicalResearch.com: What should readers take away from your report?
Response: In this trial involving children 4-11 years of age with asthma, salmeterol in a fixed-dose combination with fluticasone was associated with the risk of a serious asthma-related event that was similar to the risk with fluticasone alone.
The only serious adverse events noted in this trial were asthma-related hospitalizations. There were no asthma related deaths.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Future research will be addressed after the Food and Drug Administration review of these data and the data from the adult and adolescent studies addressing this same issue.
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