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

Phase 2

Completed

• Conditions: Rhinovirus
• Interventions: Drug: BTA798; Drug: Placebo

• Registration Number: NCT01175226
• Lead Sponsor: Biota Scientific Management Pty Ltd

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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-03
• Study First Submitted QC: 2010-08-03
• Study First Posted: 2010-08-04
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Disposition First Submitted: 2013-09-12
• Disposition First Submitted QC: 2013-09-12
• Disposition First Posted: 2013-09-18
• Results First Submitted: 2017-03-17
• Results First Submitted QC: 2017-04-27
• Results First Posted: 2017-06-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-29
• Last Update Posted: 2018-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BTA798	BTA798	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire	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.

Trial Locations

Locations (1)

Research Site; 🇺🇸 West Allis, Wisconsin, United States