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
  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

Resource links provided by NLM:


Further study details as provided by Biota Scientific Management Pty Ltd:

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
Other Name: Intervention other name not applicable.
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
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

  Hide Study Locations
Locations
United States, Arizona
Research Site
Scottsdale, Arizona, United States, 85251
United States, Arkansas
Research Site
Little Rock, Arkansas, United States, 72205
United States, California
Research Site
Fountain Valley, California, United States, 92708
Research Site
Orange, California, United States, 92868
United States, Connecticut
Research Site
Waterbury, Connecticut, United States, 06709
United States, Florida
Research Site
Hialeah, Florida, United States, 33016
United States, Maine
Research Site
Bangor, Maine, United States, 04401
United States, Maryland
Research Site
Baltimore, Maryland, United States, 21236
Research Site
Bethesda, Maryland, United States, 20814
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02115
United States, Missouri
Research Site
St Louis, Missouri, United States, 63141
Research Site
St. Louis, Missouri, United States, 63141
United States, Nebraska
Research Site
Omaha, Nebraska, United States, 68134
Research Site
Omaha, Nebraska, United States, 68130
Research Site
Papillion, Nebraska, United States, 68046
United States, New Mexico
Research Site
Albuquerque, New Mexico, United States, 87108
United States, New York
Research Site
Newburgh, New York, United States, 12550
Research Site
North Syracuse, New York, United States, 13212
Research Site
NY, New York, United States, 10016
Research Site
Rockville Centre, New York, United States, 11570
United States, North Carolina
Research Site
Asheville, North Carolina, United States, 28801
Research Site
Raleigh, North Carolina, United States, 27612
United States, North Dakota
Research Site
Fargo, North Dakota, United States, 58103
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45242
Research Site
Cincinnatti, Ohio, United States, 45267
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States, 73120
Research Site
Oklahoma City, Oklahoma, United States, 73131
United States, Oregon
Research Site
Lake Oswego, Oregon, United States, 97035
Research Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
Research Site
Hershey, Pennsylvania, United States, 17033
Research Site
Philadelphia, Pennsylvania, United States, 19115
Research Site
Pittsburgh, Pennsylvania, United States, 15241
Research Site
Pittsburgh, Pennsylvania, United States, 15221
Research Site
Upland, Pennsylvania, United States, 19013
United States, Rhode Island
Research Site
East Providence, Rhode Island, United States, 02914
Research Site
Lincoln, Rhode Island, United States, 02865
Research Site
Providence, Rhode Island, United States, 02906
United States, Texas
Research Site
San Antonio, Texas, United States, 78229
Research Site
Waco, Texas, United States, 76712
United States, Vermont
Research Site
South Burlington, Vermont, United States, 05403
United States, Virginia
Research Site
Richmond, Virginia, United States, 23229
United States, Wisconsin
Research Site
Greenfield, Wisconsin, United States, 53228
Research Site
Madison, Wisconsin, United States, 53792
Research Site
West Allis, Wisconsin, United States, 53227
Sponsors and Collaborators
Biota Scientific Management Pty Ltd
Investigators
Study Director: John Lambert, PhD Biota Scientific Management
  More Information

No publications provided

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: September 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Biota Scientific Management Pty Ltd:
Human rhinovirus

ClinicalTrials.gov processed this record on August 18, 2014