A Phase 2 Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection
RHINO
A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection
1 other identifier
interventional
300
1 country
43
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2010
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 3, 2010
CompletedFirst Posted
Study publicly available on registry
August 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
June 1, 2017
CompletedMay 31, 2018
May 1, 2018
1.6 years
August 3, 2010
March 17, 2017
May 29, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
BTA798
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Research Site
Scottsdale, Arizona, 85251, United States
Research Site
Little Rock, Arkansas, 72205, United States
Research Site
Fountain Valley, California, 92708, United States
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Orange, California, 92868, United States
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Waterbury, Connecticut, 06709, United States
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Hialeah, Florida, 33016, United States
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Bangor, Maine, 04401, United States
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Baltimore, Maryland, 21236, United States
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Bethesda, Maryland, 20814, United States
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Boston, Massachusetts, 02115, United States
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St Louis, Missouri, 63141, United States
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Omaha, Nebraska, 68130, United States
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Omaha, Nebraska, 68134, United States
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Papillion, Nebraska, 68046, United States
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Albuquerque, New Mexico, 87108, United States
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New York, New York, 10016, United States
Research Site
Newburgh, New York, 12550, United States
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North Syracuse, New York, 13212, United States
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Rockville Centre, New York, 11570, United States
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Asheville, North Carolina, 28801, United States
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Raleigh, North Carolina, 27612, United States
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Fargo, North Dakota, 58103, United States
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Cincinnati, Ohio, 45242, United States
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Cincinnati, Ohio, 45267, United States
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Oklahoma City, Oklahoma, 73120, United States
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Oklahoma City, Oklahoma, 73131, United States
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Lake Oswego, Oregon, 97035, United States
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Medford, Oregon, 97504, United States
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Hershey, Pennsylvania, 17033, United States
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Philadelphia, Pennsylvania, 19115, United States
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Pittsburgh, Pennsylvania, 15221, United States
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Pittsburgh, Pennsylvania, 15241, United States
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Upland, Pennsylvania, 19013, United States
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East Providence, Rhode Island, 02914, United States
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Lincoln, Rhode Island, 02865, United States
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Providence, Rhode Island, 02906, United States
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San Antonio, Texas, 78229, United States
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Waco, Texas, 76712, United States
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South Burlington, Vermont, 05403, United States
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Richmond, Virginia, 23229, United States
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Greenfield, Wisconsin, 53228, United States
Research Site
Madison, Wisconsin, 53792, United States
Research Site
West Allis, Wisconsin, 53227, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anna Novotney-Barry
- Organization
- Aviragen Therapeutics, Inc.
Study Officials
- STUDY DIRECTOR
John Lambert, PhD
Biota Scientific Management Pty Ltd
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2010
First Posted
August 4, 2010
Study Start
August 1, 2010
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
May 31, 2018
Results First Posted
June 1, 2017
Record last verified: 2018-05