A Phase 2 Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection (RHINO)
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.
|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|
- Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire [ Time Frame: Days 2-4 ] [ Designated as safety issue: No ]
|Study Start Date:||August 2010|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
BTA798 twice daily
Other Name: Intervention other name not applicable.
|Placebo Comparator: Placebo||
Placebo twice daily
Other Name: Glucose
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.
Show 44 Study Locations
|Study Director:||John Lambert, PhD||Biota Scientific Management|