Rhinovirus
Conditions
Keywords
Human rhinovirus, Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen
Brief 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.
Detailed 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.
Interventions
DRUGBTA798
BTA798 twice daily
DRUGPlacebo
Placebo twice daily
Sponsors
Biota Scientific Management Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire | Days 2-4 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BTA798 BTA798: BTA798 twice daily | 154 |
| Placebo Placebo: Placebo twice daily | 145 |
| Total | 299 |
Baseline characteristics
| Characteristic | BTA798 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 40.6 years STANDARD_DEVIATION 14.34 | 42.0 years STANDARD_DEVIATION 13.69 | 41.3 years STANDARD_DEVIATION 14.02 |
| Region of Enrollment United States | 154 participants | 145 participants | 299 participants |
| Sex: Female, Male Female | 114 Participants | 95 Participants | 209 Participants |
| Sex: Female, Male Male | 40 Participants | 50 Participants | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 154 | 0 / 145 |
| other Total, other adverse events | 22 / 154 | 18 / 145 |
| serious Total, serious adverse events | 0 / 154 | 0 / 145 |
Outcome results
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.
Time frame: Days 2-4
Population: Intent-to-Treat Infected (ITT-I) Population - all randomized subjects who had a PCR positive result for rhinovirus from nasal swab on Days 1, 3, 5 and 7 with at least 1 post-baseline measurement of efficacy.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BTA798 | Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire | -9.12 Scores on a scale | Standard Error 1.403 |
| Placebo | Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire | -5.11 Scores on a scale | Standard Error 1.184 |
p-value: 0.02ANCOVA