NCT02367313

A Phase 2 Study of Vapendavir in Asthmatic Adults With Symptomatic Human Rhinovirus Infection

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Dose-ranging Study of Vapendavir in Moderate to Severe Asthmatic Adults With Symptomatic Human Rhinovirus Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 455 (actual)
• Sponsor: Biota Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This Phase 2 protocol is designed to compare two dose levels of Vapendavir versus placebo. The objectives are to obtain safety and efficacy data in moderate to severe asthmatic patients, aged 18 to 75 years at risk of loss of asthma control due to presumptive Human Rhinovirus infection.

Detailed description

This is a multicenter trial to be conducted at approximately 60 sites among 6-8 northern hemisphere countries in North America and Central Europe. Sufficient patients will be randomized in order to recruit 150 subjects who are laboratory confirmed for human rhinovirus (HRV) infection. Depending on HRV PCR positivity rates, it is expected that randomization of 250-480 subjects will be required to achieve this number of subjects with HRV infection. Appropriate asthma subjects will be screened up to 180 days prior to presentation at the study site with symptoms of presumed HRV infection for potential study inclusion on Study Day 1. The study drug treatment period has a duration of 7 days, beginning on Study Day 1. Follow-up study visits to the clinic occur on Study Days 3, 5, 7, 14, 21, and 28 with a telephonic final safety follow-up visit conducted on Study Day 35. Thus, depending on the duration of the screening period, a subject's duration of participation can be estimated to last from approximately 37 days up to 215 days.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Vapendavir	Vapendavir 264 mg twice daily
DRUG	Vapendavir	Vapendavir 528 mg twice daily
DRUG	Placebo	Placebo twice daily

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-02-20
• Last updated: 2018-06-01

Locations

62 sites across 6 countries: United States, Bulgaria, Czechia, Georgia, Poland, Romania