RT Journal Article
SR Electronic
T1 Vapendavir significantly improves upper respiratory symptoms of naturally acquired rhinovirus infection in asthmatic adults: Results of a phase 2 clinical trial
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 1493
VO 42
IS Suppl 57
A1 Jonathan Matz
YR 2013
UL http://erj.ersjournals.com/content/42/Suppl_57/1493.abstract
AB Human rhinovirus (HRV) infections are a major cause of hospitalisation for patients with asthma, and there is currently no effective treatment for HRV infection. Vapendavir is being developed as an oral antiviral to treat HRV infection. This study assessed the efficacy and safety of vapendavir in adult asthmatic subjects that have a history of increased asthma symptoms during naturally acquired rhinovirus infection.ObjectiveThe primary objective was to evaluate the effect of vapendavir on symptoms of presumptive HRV infection in asthmatic adults, as measured by the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) severity scores.MethodsThis was a Phase 2, multicentre, randomised, double-blind, placebo-controlled study in asthmatic adults with symptomatic, naturally acquired rhinovirus infection. Subjects received 400 mg of vapendavir, or placebo, twice daily for six days. The primary efficacy parameter was the mean daily difference between the vapendavir and placebo groups in the WURSS-21 severity score averaged over Days 2 through 4.ResultsThere was a statistically significant reduction in the severity score of cold symptoms averaged over Days 2 through 4 in the vapendavir-treated group compared to the placebo group (p = 0.020).There were no serious adverse events and vapendavir was generally well tolerated.ConclusionsVapendavir significantly decreased HRV-related upper respiratory symptoms in asthmatic adults and may be an effective therapy to reduce HRV related symptoms in other vulnerable respiratory subjects.