Clinical trial NCT01175226: A Phase 2 Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection
Official title: A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhinovirus
Keywords: Human rhinovirus
Aviragen Therapeutics, Inc.
Aviragen Therapeutics
Aviragen
Lead sponsor: Vaxart
Sponsor class: INDUSTRY
First posted: 2010-08-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the safety, tolerability and effectiveness of BTA798 on

* shortening the length and reducing the symptoms of human rhinovirus infection (also known as the common cold),
* controlling asthma symptoms, and
* lowering the risk of asthma symptoms worsening in subjects with asthma.

Detailed description: Subjects with a previous diagnosis of asthma will be pre screened within 90 days prior to enrolment. If a subject develops symptoms of human rhinovirus (HRV) infection they will visit the site for assessment. Symptomatic subjects meeting all eligibility criteria will be invited to enroll.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects aged 18-70 years
* Diagnosis of asthma consistent with Global Initiative for Asthma (GINA) steps 1 to 3
* Presumptive human rhinovirus infection

Exclusion Criteria:

* Current severe asthma exacerbation
* Severe asthma, GINA steps 4 or higher
* Uncontrolled or clinically significant medical condition, disease or event which could impact subject safety and/or study evaluations and/or compliance to the protocol
* Current smoker, ex-smoker of \<1 year, or history of smoking \>/=10 pack years.

Primary outcomes:
measure: Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire
timeFrame: Days 2-4
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Fountain Valley
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: Waterbury
country: United States
facility: Research Site
state: Connecticut
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Bangor
country: United States
facility: Research Site
state: Maine
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Bethesda
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Papillion
country: United States
facility: Research Site
state: Nebraska
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: New York
country: United States
facility: Research Site
state: New York
city: Newburgh
country: United States
facility: Research Site
state: New York
city: North Syracuse
country: United States
facility: Research Site
state: New York
city: Rockville Centre
country: United States
facility: Research Site
state: New York
city: Asheville
country: United States
facility: Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Fargo
country: United States
facility: Research Site
state: North Dakota
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Lake Oswego
country: United States
facility: Research Site
state: Oregon
city: Medford
country: United States
facility: Research Site
state: Oregon
city: Hershey
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Upland
country: United States
facility: Research Site
state: Pennsylvania
city: East Providence
country: United States
facility: Research Site
state: Rhode Island
city: Lincoln
country: United States
facility: Research Site
state: Rhode Island
city: Providence
country: United States
facility: Research Site
state: Rhode Island
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Waco
country: United States
facility: Research Site
state: Texas
city: South Burlington
country: United States
facility: Research Site
state: Vermont
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Greenfield
country: United States
facility: Research Site
state: Wisconsin
city: Madison
country: United States
facility: Research Site
state: Wisconsin
city: West Allis
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: Biota Scientific Management Pty Ltd
name: John Lambert, PhD
role: STUDY_DIRECTOR
References: