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

May 29, 2018 updated by: Biota Scientific Management Pty Ltd

A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Research Site
    • California
      • Fountain Valley, California, United States, 92708
        • Research Site
      • Orange, California, United States, 92868
        • Research Site
    • Connecticut
      • Waterbury, Connecticut, United States, 06709
        • Research Site
    • Florida
      • Hialeah, Florida, United States, 33016
        • Research Site
    • Maine
      • Bangor, Maine, United States, 04401
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21236
        • Research Site
      • Bethesda, Maryland, United States, 20814
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Research Site
      • Omaha, Nebraska, United States, 68134
        • Research Site
      • Papillion, Nebraska, United States, 68046
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Research Site
    • New York
      • New York, New York, United States, 10016
        • Research Site
      • Newburgh, New York, United States, 12550
        • Research Site
      • North Syracuse, New York, United States, 13212
        • Research Site
      • Rockville Centre, New York, United States, 11570
        • Research Site
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Research Site
      • Raleigh, North Carolina, United States, 27612
        • Research Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Research Site
      • Cincinnati, Ohio, United States, 45267
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Research Site
      • Oklahoma City, Oklahoma, United States, 73131
        • Research Site
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
        • Research Site
      • Medford, Oregon, United States, 97504
        • Research Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19115
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15241
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15221
        • Research Site
      • Upland, Pennsylvania, United States, 19013
        • Research Site
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Research Site
      • Lincoln, Rhode Island, United States, 02865
        • Research Site
      • Providence, Rhode Island, United States, 02906
        • Research Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • Research Site
      • Waco, Texas, United States, 76712
        • Research Site
    • Vermont
      • South Burlington, Vermont, United States, 05403
        • Research Site
    • Virginia
      • Richmond, Virginia, United States, 23229
        • Research Site
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228
        • Research Site
      • Madison, Wisconsin, United States, 53792
        • Research Site
      • West Allis, Wisconsin, United States, 53227
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo twice daily
Other Names:
  • Glucose
Experimental: BTA798
Drug: BTA798
BTA798 twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire
Time Frame: 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.
Days 2-4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biota Scientific Management Pty Ltd

Investigators

  • Study Director: John Lambert, PhD, Biota Scientific Management Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

August 3, 2010

First Submitted That Met QC Criteria

August 3, 2010

First Posted (Estimate)

August 4, 2010

Study Record Updates

Last Update Posted (Actual)

May 31, 2018

Last Update Submitted That Met QC Criteria

May 29, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTA798-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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