RhinovirusPhase 2RHINONCT01175226

A Phase 2 Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection

A Phase 2 study testing BTA798 in people with Rhinovirus, run by Biota Scientific Management Pty Ltd at 43 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Rhinovirus
What is being tested?: BTA798
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 300 participants
Where: 43 sitesUnited States
Study dates: Aug 2010to Mar 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

43 sites in 1 country.

City, postcode or hospital

43 sites in 1 country

United States43 sites

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

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Rhinovirus
Being tested: BTA798, Placebo
Keywords: Human rhinovirus, Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BTA798Drug
BTA798 twice daily
PlaceboDrug
Also called Glucose
Placebo twice daily

Study groups in NCT01175226
Study group	Role	What they receive
BTA798	Experimental	Not described Receives: Drug: BTA798
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire
Daily Change in WURSS-21 Severity Score Averaged over Days 2 to 4. The Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire is an evaluative illness-specific outcomes instrument designed to assess the severity of cold symptoms and the impact of the common cold (range 0-140), with higher scores indicating more symptoms and functional impairment.
Measured: Days 2-4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Mar 2012

First posted4 Aug 2010 (estimated)
Study startAug 2010
Primary completionMar 2012
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for RhinovirusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01175226
Sponsor's protocol ID: BTA798-202
Acronym: RHINO
Status last verified: May 2018
First submitted: 3 Aug 2010
Last updated: 31 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Trial Comparing the Safety and Efficacy of Two Different Oral VPV Doses With Placebo as Treatment for RV in Participants With COPD
Rhinovirus Infection
Not yet recruitingObservational study
ELderly REspiratory VIral Cohort
Influenza Viruses, Respiratory Syncytial Virus (RSV)
RecruitingPhase 1/2
RIG 101 Trial in Healthy Adults and Adults With Asthma
Healthy Adult Participants, Asthma Exacerbation
RecruitingObservational study
The Rhinovirus Hospitalization and Investigation of Nasal-airway Omics (RHINO) Study
Rhinovirus
RecruitingObservational study
Virological Surveillance of Acute Respiratory Infection in Primary Health Care in Metropolitan France
Respiratory Tract Infections (RTI), Influenza -Like Illness

All Rhinovirus trials

Study at a glance

From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection
ClinicalTrials.gov ID: NCT01175226
Acronym / sponsor ID: RHINO / BTA798-202
Conditions: Rhinovirus
Keywords: Human rhinovirus, Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Biota Scientific Management Pty LtdIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 4 Aug 2010 (estimated)
Results: Posted 1 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
BTA798	Experimental	Drug: BTA798
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BTA798BTA798 twice daily	Drug	BTA798
PlaceboAlso: GlucosePlacebo twice daily	Drug	Placebo

Primary outcome

Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire
Time frame: Days 2-4
Daily Change in WURSS-21 Severity Score Averaged over Days 2 to 4. The Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire is an evaluative illness-specific outcomes instrument designed to assess the severity of cold symptoms and the impact of the common cold (range 0-140), with higher scores indicating more symptoms and functional impairment.

Results and safety

Results posted to the registry on 1 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BTA798	155	144
Placebo	145	140

Primary outcome: Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire

Time frame: Days 2-4. Least squares mean (Standard Error). Unit: Scores on a scale

Measure	BTA798 n = 42	Placebo n = 50
Value	-9.12 (1.403)	-5.11 (1.184)

BTA798 vs Placebo: p = 0.020, ANCOVA

Population analysed: Intent-to-Treat Infected (ITT-I) Population - all randomized subjects who had a PCR positive result for rhinovirus from nasal swab on Days 1, 3, 5 and 7 with at least 1 post-baseline measurement of efficacy.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BTA798	0 of 154 (0%)	22 of 154 (14.3%)	0 of 154
Placebo	0 of 145 (0%)	18 of 145 (12.4%)	0 of 145

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rhinovirus

RecruitingPhase 2
Trial Comparing the Safety and Efficacy of Two Different Oral VPV Doses With Placebo as Treatment for RV in Participants With COPD
Rhinovirus Infection
Not yet recruitingObservational study
ELderly REspiratory VIral Cohort
Influenza Viruses, Respiratory Syncytial Virus (RSV)
RecruitingPhase 1/2
RIG 101 Trial in Healthy Adults and Adults With Asthma
Healthy Adult Participants, Asthma Exacerbation
RecruitingObservational study
The Rhinovirus Hospitalization and Investigation of Nasal-airway Omics (RHINO) Study
Rhinovirus
RecruitingObservational study
Virological Surveillance of Acute Respiratory Infection in Primary Health Care in Metropolitan France
Respiratory Tract Infections (RTI), Influenza -Like Illness

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Lambert, PhD study director

Biota Scientific Management Pty Ltd

43 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BTA798 in people with Rhinovirus, run by Biota Scientific Management Pty Ltd at 43 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire (time frame: Days 2-4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01175226.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2018.