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 |
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.
- 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.
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.
We found this trial at
39
sites
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