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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: July 14, 2016
Last verified: July 2016
  Purpose

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.

Condition Intervention Phase
Rhinovirus
Drug: BTA798
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection

Further study details as provided by Aviragen Therapeutics:

Primary Outcome Measures:
  • Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire [ Time Frame: Days 2-4 ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: August 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BTA798 Drug: BTA798
BTA798 twice daily
Placebo Comparator: Placebo Drug: Placebo
Placebo twice daily
Other Name: Glucose

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175226

  Show 44 Study Locations
Sponsors and Collaborators
Biota Scientific Management Pty Ltd
Investigators
Study Director: John Lambert, PhD Biota Scientific Management Pty Ltd
  More Information

Responsible Party: Biota Scientific Management Pty Ltd
ClinicalTrials.gov Identifier: NCT01175226     History of Changes
Other Study ID Numbers: BTA798-202 
Study First Received: August 3, 2010
Last Updated: July 14, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Aviragen Therapeutics:
Human rhinovirus
Aviragen Therapeutics, Inc.
Aviragen Therapeutics
Aviragen

ClinicalTrials.gov processed this record on December 05, 2016