Phase 2
N=300
A Phase 2 Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection
Rhinovirus
Bottom Line
View on ClinicalTrials.gov: NCT01175226 ↗Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire — -9.12; -5.11 Scores on a scale — p=0.020
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BTA798 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biota Scientific Management Pty Ltd
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire |
-9.12; -5.11 | 0.020 sig |
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.
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 /=10 pack years.
Data sourced from ClinicalTrials.gov (NCT01175226). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.