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

Biota Scientific Management

Status and phase

Completed

Phase 2

Conditions

Rhinovirus

Treatments

Drug: BTA798

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01175226

BTA798-202

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.