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

NCT02367313 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 455

Last updated 2018-06-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Vapendavir

Vapendavir 264 mg twice daily

DRUG

Vapendavir

Vapendavir 528 mg twice daily

DRUG

Placebo

Placebo twice daily

Sponsors & Collaborators

  • Biota Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Anna Novotney-Barry · Biota Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States
  • Bulgaria
  • Czechia
  • Georgia
  • Poland
  • Romania

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02367313 on ClinicalTrials.gov