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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:
Information provided by (Responsible Party):
Aviragen Therapeutics ( Biota Scientific Management Pty Ltd )
ClinicalTrials.gov Identifier:
NCT01175226
First received: August 3, 2010
Last updated: April 27, 2017
Last verified: April 2017
Results First Received: March 17, 2017  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
BTA798 BTA798: BTA798 twice daily
Placebo Placebo: Placebo twice daily

Participant Flow:   Overall Study
    BTA798   Placebo
STARTED   155   145 
COMPLETED   144   140 
NOT COMPLETED   11   5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population - all randomized subjects who received at least 1 dose of investiational product.

Reporting Groups
  Description
BTA798 BTA798: BTA798 twice daily
Placebo Placebo: Placebo twice daily
Total Total of all reporting groups

Baseline Measures
   BTA798   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 154   145   299 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.6  (14.34)   42.0  (13.69)   41.3  (14.02) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      114  74.0%      95  65.5%      209  69.9% 
Male      40  26.0%      50  34.5%      90  30.1% 
Region of Enrollment 
[Units: Participants]
     
United States   154   145   299 


  Outcome Measures

1.  Primary:   Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire   [ Time Frame: Days 2-4 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Anna Novotney-Barry
Organization: Aviragen Therapeutics, Inc.
phone: 678-221-3356
e-mail: abarry@aviragentherapeutics.com



Responsible Party: Aviragen Therapeutics ( Biota Scientific Management Pty Ltd )
ClinicalTrials.gov Identifier: NCT01175226     History of Changes
Other Study ID Numbers: BTA798-202
Study First Received: August 3, 2010
Results First Received: March 17, 2017
Last Updated: April 27, 2017