A Phase 2 Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection

Rhinovirus Clinical Trial

— RHINO  

Official title:

A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01175226
• Other study ID #: BTA798-202
• Status: Completed
• Phase: Phase 2
• Start date: August 2010
• Est. completion date: March 2012

Study information

• Verified date: May 2018
• Source: Vaxart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rhinovirus

Intervention

Drug:
• BTA798
BTA798 twice daily
• Placebo
Placebo twice daily

Locations

Country	Name	City	State
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Asheville	North Carolina
United States	Research Site	Baltimore	Maryland
United States	Research Site	Bangor	Maine
United States	Research Site	Bethesda	Maryland
United States	Research Site	Boston	Massachusetts
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Cincinnati	Ohio
United States	Research Site	East Providence	Rhode Island
United States	Research Site	Fargo	North Dakota
United States	Research Site	Fountain Valley	California
United States	Research Site	Greenfield	Wisconsin
United States	Research Site	Hershey	Pennsylvania
United States	Research Site	Hialeah	Florida
United States	Research Site	Lake Oswego	Oregon
United States	Research Site	Lincoln	Rhode Island
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Madison	Wisconsin
United States	Research Site	Medford	Oregon
United States	Research Site	New York	New York
United States	Research Site	Newburgh	New York
United States	Research Site	North Syracuse	New York
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Omaha	Nebraska
United States	Research Site	Omaha	Nebraska
United States	Research Site	Orange	California
United States	Research Site	Papillion	Nebraska
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Providence	Rhode Island
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Richmond	Virginia
United States	Research Site	Rockville Centre	New York
United States	Research Site	Saint Louis	Missouri
United States	Research Site	San Antonio	Texas
United States	Research Site	Scottsdale	Arizona
United States	Research Site	South Burlington	Vermont
United States	Research Site	Upland	Pennsylvania
United States	Research Site	Waco	Texas
United States	Research Site	Waterbury	Connecticut
United States	Research Site	West Allis	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Biota Scientific Management Pty Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire	Daily Change in WURSS-21 Severity Score Averaged over Days 2 to 4. The Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire is an evaluative illness-specific outcomes instrument designed to assess the severity of cold symptoms and the impact of the common cold (range 0-140), with higher scores indicating more symptoms and functional impairment.	Days 2-4