Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to evaluate the safety, tolerability and effectiveness of BTA798 on
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTA798 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTA798 | Drug | BTA798 twice daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 2-4 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John Lambert, PhD | Biota Scientific Management Pty Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Scottsdale | Arizona | 85251 | United States | ||
| Research Site |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BTA798 | BTA798: BTA798 twice daily |
| FG001 | Placebo | Placebo: Placebo twice daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Placebo twice daily |
|
|
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Research Site | Fountain Valley | California | 92708 | United States |
| Research Site | Orange | California | 92868 | United States |
| Research Site | Waterbury | Connecticut | 06709 | United States |
| Research Site | Hialeah | Florida | 33016 | United States |
| Research Site | Bangor | Maine | 04401 | United States |
| Research Site | Baltimore | Maryland | 21236 | United States |
| Research Site | Bethesda | Maryland | 20814 | United States |
| Research Site | Boston | Massachusetts | 02115 | United States |
| Research Site | St Louis | Missouri | 63141 | United States |
| Research Site | Omaha | Nebraska | 68130 | United States |
| Research Site | Omaha | Nebraska | 68134 | United States |
| Research Site | Papillion | Nebraska | 68046 | United States |
| Research Site | Albuquerque | New Mexico | 87108 | United States |
| Research Site | New York | New York | 10016 | United States |
| Research Site | Newburgh | New York | 12550 | United States |
| Research Site | North Syracuse | New York | 13212 | United States |
| Research Site | Rockville Centre | New York | 11570 | United States |
| Research Site | Asheville | North Carolina | 28801 | United States |
| Research Site | Raleigh | North Carolina | 27612 | United States |
| Research Site | Fargo | North Dakota | 58103 | United States |
| Research Site | Cincinnati | Ohio | 45242 | United States |
| Research Site | Cincinnati | Ohio | 45267 | United States |
| Research Site | Oklahoma City | Oklahoma | 73120 | United States |
| Research Site | Oklahoma City | Oklahoma | 73131 | United States |
| Research Site | Lake Oswego | Oregon | 97035 | United States |
| Research Site | Medford | Oregon | 97504 | United States |
| Research Site | Hershey | Pennsylvania | 17033 | United States |
| Research Site | Philadelphia | Pennsylvania | 19115 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15221 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15241 | United States |
| Research Site | Upland | Pennsylvania | 19013 | United States |
| Research Site | East Providence | Rhode Island | 02914 | United States |
| Research Site | Lincoln | Rhode Island | 02865 | United States |
| Research Site | Providence | Rhode Island | 02906 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | Waco | Texas | 76712 | United States |
| Research Site | South Burlington | Vermont | 05403 | United States |
| Research Site | Richmond | Virginia | 23229 | United States |
| Research Site | Greenfield | Wisconsin | 53228 | United States |
| Research Site | Madison | Wisconsin | 53792 | United States |
| Research Site | West Allis | Wisconsin | 53227 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Safety population - all randomized subjects who received at least 1 dose of investiational product.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BTA798 | BTA798: BTA798 twice daily |
| BG001 | Placebo | Placebo: Placebo twice daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Days 2-4 |
|
|
|
|
Not provided
Adverse events are reported for the Safety Population defined as all randomized subjects who met the eligibility criteria and were randomized.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BTA798 | BTA798: BTA798 twice daily | 0 | 154 | 0 | 154 | 22 | 154 |
| EG001 | Placebo | Placebo: Placebo twice daily | 0 | 145 | 0 | 145 | 18 | 145 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders |
| |||
| Upper Respiratory Tract Infection | Infections and infestations |
| |||
| Sinusitis | Infections and infestations |
| |||
| Asthma | Respiratory, thoracic and mediastinal disorders |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Novotney-Barry | Aviragen Therapeutics, Inc. | 678-221-3356 | abarry@aviragentherapeutics.com |
| ID | Term |
|---|---|
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
Not provided
Not provided
| Male |
|