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

NCT ID: NCT01175226

Last Updated: 2018-05-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rhinovirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BTA798

Group Type EXPERIMENTAL

BTA798

Intervention Type DRUG

BTA798 twice daily

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo twice daily

Interventions

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BTA798

BTA798 twice daily

Intervention Type DRUG

Placebo

Placebo twice daily

Intervention Type DRUG

Other Intervention Names

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Glucose

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biota Scientific Management Pty Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Lambert, PhD

Role: STUDY_DIRECTOR

Biota Scientific Management Pty Ltd

Locations

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Research Site

Scottsdale, Arizona, United States

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Little Rock, Arkansas, United States

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Fountain Valley, California, United States

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Orange, California, United States

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Waterbury, Connecticut, United States

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Hialeah, Florida, United States

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Bangor, Maine, United States

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Baltimore, Maryland, United States

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Bethesda, Maryland, United States

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Boston, Massachusetts, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Papillion, Nebraska, United States

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Albuquerque, New Mexico, United States

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New York, New York, United States

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Newburgh, New York, United States

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North Syracuse, New York, United States

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Rockville Centre, New York, United States

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Asheville, North Carolina, United States

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Raleigh, North Carolina, United States

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Fargo, North Dakota, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Lake Oswego, Oregon, United States

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Medford, Oregon, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Upland, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Lincoln, Rhode Island, United States

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Providence, Rhode Island, United States

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San Antonio, Texas, United States

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Waco, Texas, United States

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South Burlington, Vermont, United States

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Richmond, Virginia, United States

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Greenfield, Wisconsin, United States

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Madison, Wisconsin, United States

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West Allis, Wisconsin, United States

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Countries

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United States

Other Identifiers

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BTA798-202

Identifier Type: -

Identifier Source: org_study_id

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