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Completed

NCT Number: NCT01175226

A Phase 2 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.

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Key information

Conditions

Rhinovirus

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Scottsdale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BTA798

Drug

BTA798 twice daily

Placebo

Drug

Placebo twice daily

Other names: Glucose

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Biota Scientific Management Pty Ltd

Industry

Registry information

Official study title

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

Acronym: RHINO

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 4, 2010
Registry last updated
May 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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