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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 )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rhinovirus
Interventions Drug: BTA798
Drug: Placebo
Enrollment 300
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BTA798 Placebo
Hide Arm/Group Description BTA798: BTA798 twice daily Placebo: Placebo twice daily
Period Title: Overall Study
Started 155 145
Completed 144 140
Not Completed 11 5
Arm/Group Title BTA798 Placebo Total
Hide Arm/Group Description BTA798: BTA798 twice daily Placebo: Placebo twice daily Total of all reporting groups
Overall Number of Baseline Participants 154 145 299
Hide Baseline Analysis Population Description
Safety population - all randomized subjects who received at least 1 dose of investiational product.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 154 participants 145 participants 299 participants
40.6  (14.34) 42.0  (13.69) 41.3  (14.02)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 154 participants 145 participants 299 participants
Female
114
  74.0%
95
  65.5%
209
  69.9%
Male
40
  26.0%
50
  34.5%
90
  30.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 154 participants 145 participants 299 participants
154 145 299
1.Primary Outcome
Title Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire
Hide Description 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.
Time Frame Days 2-4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Infected (ITT-I) Population - all randomized subjects who had a PCR positive result for rhinovirus from nasal swab on Days 1, 3, 5 and 7 with at least 1 post-baseline measurement of efficacy.
Arm/Group Title BTA798 Placebo
Hide Arm/Group Description:
BTA798: BTA798 twice daily
Placebo: Placebo twice daily
Overall Number of Participants Analyzed 42 50
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-9.12  (1.403) -5.11  (1.184)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BTA798, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events are reported for the Safety Population defined as all randomized subjects who met the eligibility criteria and were randomized.
 
Arm/Group Title BTA798 Placebo
Hide Arm/Group Description BTA798: BTA798 twice daily Placebo: Placebo twice daily
All-Cause Mortality
BTA798 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/154 (0.00%)   0/145 (0.00%) 
Hide Serious Adverse Events
BTA798 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/154 (0.00%)   0/145 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
BTA798 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   22/154 (14.29%)   18/145 (12.41%) 
Infections and infestations     
Upper Respiratory Tract Infection  5/154 (3.25%)  5/145 (3.45%) 
Sinusitis  5/154 (3.25%)  4/145 (2.76%) 
Nervous system disorders     
Headache  7/154 (4.55%)  6/145 (4.14%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  5/154 (3.25%)  3/145 (2.07%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anna Novotney-Barry
Organization: Aviragen Therapeutics, Inc.
Phone: 678-221-3356
EMail: abarry@aviragentherapeutics.com
Layout table for additonal information
Responsible Party: Vaxart ( Biota Scientific Management Pty Ltd )
ClinicalTrials.gov Identifier: NCT01175226    
Other Study ID Numbers: BTA798-202
First Submitted: August 3, 2010
First Posted: August 4, 2010
Results First Submitted: March 17, 2017
Results First Posted: June 1, 2017
Last Update Posted: May 31, 2018