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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01175226
First Posted: August 4, 2010
Last Update Posted: June 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aviragen Therapeutics ( Biota Scientific Management Pty Ltd )
August 3, 2010
August 4, 2010
March 17, 2017
June 1, 2017
June 1, 2017
August 2010
March 2012   (Final data collection date for primary outcome measure)
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.
WURSS-21 Questionnaire [ Time Frame: Days 2-4 ]
Complete list of historical versions of study NCT01175226 on ClinicalTrials.gov Archive Site
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A Phase 2 Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rhinovirus
  • Drug: BTA798
    BTA798 twice daily
  • Drug: Placebo
    Placebo twice daily
    Other Name: Glucose
  • Experimental: BTA798
    Intervention: Drug: BTA798
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
March 2012
March 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01175226
BTA798-202
Yes
Not Provided
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Aviragen Therapeutics ( Biota Scientific Management Pty Ltd )
Biota Scientific Management Pty Ltd
Not Provided
Study Director: John Lambert, PhD Biota Scientific Management Pty Ltd
Aviragen Therapeutics
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP