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



Status:Completed
Conditions:Sinusitis
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:18 - 70
Updated:6/2/2018
Start Date:August 2010
End Date:March 2012

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

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.

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.

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.
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