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

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.
 
ClinicalTrials.gov Identifier: NCT01175226
Recruitment Status : Completed
First Posted : August 4, 2010
Results First Posted : June 1, 2017
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Vaxart ( Biota Scientific Management Pty Ltd )

Tracking Information
First Submitted Date  ICMJE August 3, 2010
First Posted Date  ICMJE August 4, 2010
Results First Submitted Date  ICMJE March 17, 2017
Results First Posted Date  ICMJE June 1, 2017
Last Update Posted Date May 31, 2018
Study Start Date  ICMJE August 2010
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 3, 2010)
WURSS-21 Questionnaire [ Time Frame: Days 2-4 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection
Official Title  ICMJE A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rhinovirus
Intervention  ICMJE
  • Drug: BTA798
    BTA798 twice daily
  • Drug: Placebo
    Placebo twice daily
    Other Name: Glucose
Study Arms  ICMJE
  • Experimental: BTA798
    Intervention: Drug: BTA798
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 2, 2011)
300
Original Estimated Enrollment  ICMJE
 (submitted: August 3, 2010)
400
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01175226
Other Study ID Numbers  ICMJE BTA798-202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Vaxart ( Biota Scientific Management Pty Ltd )
Original Responsible Party Janet Wilson, Director Clinical Operations, Biota Scientific Management Pty Limited
Current Study Sponsor  ICMJE Biota Scientific Management Pty Ltd
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: John Lambert, PhD Biota Scientific Management Pty Ltd
PRS Account Vaxart
Verification Date May 2018

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