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A Phase 2 Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection (RHINO)

Primary Purpose

Rhinovirus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BTA798
Placebo
Sponsored by
Biota Scientific Management Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinovirus focused on measuring Human rhinovirus, Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BTA798

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 3, 2010
Last Updated
May 29, 2018
Sponsor
Biota Scientific Management Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01175226
Brief Title
A Phase 2 Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection
Acronym
RHINO
Official Title
A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biota Scientific Management Pty Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinovirus
Keywords
Human rhinovirus, Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BTA798
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BTA798
Intervention Description
BTA798 twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Glucose
Intervention Description
Placebo twice daily
Primary Outcome Measure Information:
Title
Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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 <1 year, or history of smoking >/=10 pack years.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Lambert, PhD
Organizational Affiliation
Biota Scientific Management Pty Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Research Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Research Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Research Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06709
Country
United States
Facility Name
Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Research Site
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
Research Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Research Site
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
Research Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Research Site
City
Newburgh
State/Province
New York
ZIP/Postal Code
12550
Country
United States
Facility Name
Research Site
City
North Syracuse
State/Province
New York
ZIP/Postal Code
13212
Country
United States
Facility Name
Research Site
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
Research Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Research Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73131
Country
United States
Facility Name
Research Site
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
Research Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Research Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19115
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15221
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Research Site
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
Research Site
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Research Site
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Research Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Research Site
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Research Site
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Research Site
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53228
Country
United States
Facility Name
Research Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Research Site
City
West Allis
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Phase 2 Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection

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