J. Matz
Sep 1, 2013
Citations
0
Influential Citations
11
Citations
Quality indicators
Journal
European Respiratory Journal
Abstract
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. Objective The 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. Methods This 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. Results There 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. Conclusions Vapendavir 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.