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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):
Biota Scientific Management Pty Ltd
ClinicalTrials.gov Identifier:
NCT01175226
First received: August 3, 2010
Last updated: September 12, 2013
Last verified: September 2013

August 3, 2010
September 12, 2013
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 ] [ Designated as safety issue: No ]
WURSS-21 Questionnaire [ Time Frame: Days 2-4 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01175226 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rhinovirus
  • Drug: BTA798
    BTA798 twice daily
    Other Name: Intervention other name not applicable.
  • 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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01175226
BTA798-202
Yes
Biota Scientific Management Pty Ltd
Biota Scientific Management Pty Ltd
Not Provided
Study Director: John Lambert, PhD Biota Scientific Management
Biota Scientific Management Pty Ltd
September 2013

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