AsthmaPhase 2SPIRITUSNCT02367313
A Phase 2 Study of Vapendavir in Asthmatic Adults With Symptomatic Human Rhinovirus Infection
A Phase 2 study testing Vapendavir in people with Asthma, run by Biota Pharmaceuticals, Inc. at 62 sites in 6 countries.
Trial summary
This Phase 2 protocol is designed to compare two dose levels of Vapendavir versus placebo. The objectives are to obtain safety and efficacy data in moderate to severe asthmatic patients, aged 18 to 75 years at risk of loss of asthma control due to presumptive Human Rhinovirus infection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Vapendavir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 455 participants
- Where
- 62 sitesin 6 countries
- Study dates
- Feb 2015to Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate and severe male and female asthma subjects aged 18 to 75 years, (inclusive)
- Established clinical history of Asthma for at least 1 year, and a history within the last 14 months (prior to screening) of asthma exacerbation due to presumed viral respiratory infections, which required asthma rescue medication treatment.
- The asthma subjects will be currently taking at least medium-dose or high-dose ICS defined as fluticasone at a dosage of at least >264 µg daily and may be taking other asthma medication preparations. The asthma subjects' medication regimen must be stable for at least 4 weeks before screening.
- Subjects will have at screening or within the last year, documented variable airway obstruction as indicated by an increase in FEV1 (>12%) to short acting bronchodilator, or positive methacholine challenge, or positive histamine challenge (PC20 <8 mg/mL).
- Upon presentation to the clinic with cold symptoms, subjects will be required to be randomized and treated within 48 hours of symptom onset and will be qualified for presumptive rhinovirus infection by:
- clinical exam and the presence of each of the following Day 1 WURSS-21 symptoms at a severity of 2 or greater: runny nose, sore throat, scratchy throat.
- subjects must also have a minimum total symptom score on the Day 1 WURSS-21 of 20 points.
- subjects will be further qualified as presumptively infected with HRV via exclusion of subjects having significant fever and exclusion of subjects testing positive for influenza via Rapid Antigen Test.
Who cannot join
- Subjects presenting to the clinic with a current severe asthma exacerbation will be excluded from randomization, as well as any subject with an additional underlying respiratory medical condition other than asthma such as COPD, cystic fibrosis, or chronic sinusitis, or any other uncontrolled clinically significant disease which would interfere with the assessment outcomes or subject safety.
- Female subjects must not be pregnant or breastfeeding. Females of childbearing potential must be willing to utilize a double barrier method of contraception, as defined in this protocol, regardless of any hormonal contraception they may be concomitantly receiving.
- Male subjects must agree to use a method of birth control defined in this protocol.
- The use of medications known to moderately or severely inhibit or induce cytochrome (CYP) 3A4 and 2C19 enzymes, or those known to be sensitive substrates (with a narrow therapeutic range) of these CYPs are restricted.
Trial locations and contacts
62 sites in 6 countries.
62 sites in 6 countries
United States33 sites
Biota Investigational site
Albuquerque, New Mexico, 87102
Biota Investigational site
Bakersfield, California, 93301
Biota Investigational site
Baltimore, Maryland, 21236
Biota Investigational site
Bellevue, Nebraska, 68123
Biota Investigational site
Birmingham, Alabama, 35209
Biota Investigational site
Centennial, Colorado, 80112
Biota Investigational site
Denver, Colorado, 80230
Biota Investigational site
Fargo, North Dakota, 58103
Biota Investigational site
Flagstaff, Arizona, 86001
Biota Investigational site
Greenfield, Wisconsin, 53228
Biota Investigational site
Hialeah, Florida, 33016
Biota Investigational site
Houston, Texas, 77055
Biota investigational site
Las Vegas, Nevada, 89146
Biota Investigational site
Los Angeles, California, 90025
Biota Investigational site
Medford, Oregon, 97504
Biota Investigational site
Middleburg, Ohio, 44310
Biota Investigational site
New Port Richey, Florida, 34653
Biota Investigational site
Ocean City, New Jersey, 07712
Biota Investigation site
Oklahoma City, Oklahoma, 73120
Biota Investigational site
Orange, California, 92868
Biota Investigational site
Oviedo, Florida, 32765
Biota Investigation site
Palmetto Bay, Florida, 33157
Biota Investigational site
Portland, Oregon, 97202
Biota Investigational site
Raleigh, North Carolina, 27607
Biota Investigational site
Rockville Centre, New York, 11570
Biota Investigational Site
San Jose, California, 95117
Biota Investigational site
Seattle, Washington, 98115
Biota Investigational site
St Louis, Missouri, 63141
Biota Investigational site
Stockton, California, 95207
Biota Investigational site
Tallahassee, Florida, 32308
Biota Investigational site
Toledo, Ohio, 43617
Biota Investigational site
Twin Falls, Idaho, 83301
Biota Investigational site
Warwick, Rhode Island, 02886
Poland9 sites
Biota Investigational site
Bialystok, 15-044
Biota Investigational site
Kielce, 25-734
Biota Investigational site
Krakow, 31-023
Biota Investigational site
Lodz, 90-153
Biota Investigational site
Lublin, 20-552
Biota Investigational site
Skierniewice, 96-100
Biota Investigational site
Warsaw, 01-868
Biota Investigational site
Wroclaw, 50-044
Biota Investigational site
Wroclaw, 51-162
Bulgaria6 sites
Biota Investigational site
Rousse, 7002
Biota Investigational site
Sofia, 1202
Biota Investigational site
Sofia, 1407
Biota Investigational site
Sofia, 1606
Biota Investigational site
Sofia, 1618
Biota Investigational site
Stara Zagora, 6000
Czechia6 sites
Biota Investigational site
Jindřichův Hradec, 37701
Biota Investigational site
Kyjov, 69733
Biota Investigational site
Lovosice, 41002
Biota Investigational site
Mělník, 27601
Biota Investigational site
Prague, 18200
Biota Investigational site
Rokycany, 33722
Romania5 sites
Biota Investigational site
Brasov, 500112
Biota Investigational site
Bucharest, 020671
Biota Investigational site
Craiova, 200446
Biota Investigational site
Mures, 547530
Biota Investigational site
Sibiu, 550360
Georgia3 sites
Biota Investigational site
Tbilisi, 0102
Biota Investigational site
Tbilisi, 0159
Biota Investigational site
Tbilisi, 0186
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Dose-ranging Study of Vapendavir in Moderate to Severe Asthmatic Adults With Symptomatic Human Rhinovirus Infection
This Phase 2 protocol is designed to compare two dose levels of Vapendavir versus placebo. The objectives are to obtain safety and efficacy data in moderate to severe asthmatic patients, aged 18 to 75 years at risk of loss of asthma control due to presumptive Human Rhinovirus infection.
Read the detailed description
This is a multicenter trial to be conducted at approximately 60 sites among 6-8 northern hemisphere countries in North America and Central Europe. Sufficient patients will be randomized in order to recruit 150 subjects who are laboratory confirmed for human rhinovirus (HRV) infection. Depending on HRV PCR positivity rates, it is expected that randomization of 250-480 subjects will be required to achieve this number of subjects with HRV infection.
Appropriate asthma subjects will be screened up to 180 days prior to presentation at the study site with symptoms of presumed HRV infection for potential study inclusion on Study Day 1. The study drug treatment period has a duration of 7 days, beginning on Study Day 1. Follow-up study visits to the clinic occur on Study Days 3, 5, 7, 14, 21, and 28 with a telephonic final safety follow-up visit conducted on Study Day 35. Thus, depending on the duration of the screening period, a subject's duration of participation can be estimated to last from approximately 37 days up to 215 days.
- Conditions
- Asthma
- Being tested
- Vapendavir, Placebo
- Keywords
- Symptomatic Human Rhinovirus Infection, Moderate to Severe Asthma, Antiviral, Cold, Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen
- Medical subject headings
- Asthma, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VapendavirDrug
Also called BTA798
Vapendavir 264 mg twice daily
VapendavirDrug
Also called BTA798
Vapendavir 528 mg twice daily
PlaceboDrug
Placebo twice daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Vapendavir 264 mg | Active comparator | Vapendavir 264 mg and matching placebo Receives: Drug: Vapendavir |
| Vapendavir 528 mg | Active comparator | Vapendavir 528 mg and matching placebo Receives: Drug: Vapendavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Questionnaire-6 (ACQ-6)
Least Square (LS) mean change from baseline (Day 1) to Study Day 14 in ACQ-6 total score
Measured: Baseline (Day 1) to Study Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biota Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Novotney-Barry, Study director, Biota Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367313
- Sponsor's protocol ID
- BTA798-203
- Other IDs
- 2014-001785-95, 2014
- Acronym
- SPIRITUS
- Status last verified
- May 2018
- First submitted
- 13 Feb 2015
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 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 Dose-ranging Study of Vapendavir in Moderate to Severe Asthmatic Adults With Symptomatic Human Rhinovirus Infection
- ClinicalTrials.gov ID
- NCT02367313
- Acronym / sponsor ID
- SPIRITUS / BTA798-203
- Conditions
- Asthma
- Keywords
- Symptomatic Human Rhinovirus Infection, Moderate to Severe Asthma, Antiviral, Cold, Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- Biota Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 2 protocol is designed to compare two dose levels of Vapendavir versus placebo. The objectives are to obtain safety and efficacy data in moderate to severe asthmatic patients, aged 18 to 75 years at risk of loss of asthma control due to presumptive Human Rhinovirus infection.
Detailed description
This is a multicenter trial to be conducted at approximately 60 sites among 6-8 northern hemisphere countries in North America and Central Europe. Sufficient patients will be randomized in order to recruit 150 subjects who are laboratory confirmed for human rhinovirus (HRV) infection. Depending on HRV PCR positivity rates, it is expected that randomization of 250-480 subjects will be required to achieve this number of subjects with HRV infection.
Appropriate asthma subjects will be screened up to 180 days prior to presentation at the study site with symptoms of presumed HRV infection for potential study inclusion on Study Day 1. The study drug treatment period has a duration of 7 days, beginning on Study Day 1. Follow-up study visits to the clinic occur on Study Days 3, 5, 7, 14, 21, and 28 with a telephonic final safety follow-up visit conducted on Study Day 35. Thus, depending on the duration of the screening period, a subject's duration of participation can be estimated to last from approximately 37 days up to 215 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Vapendavir 264 mg | Active comparator | Drug: VapendavirVapendavir 264 mg and matching placebo |
| Vapendavir 528 mg | Active comparator | Drug: VapendavirVapendavir 528 mg and matching placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Moderate and severe male and female asthma subjects aged 18 to 75 years, (inclusive)
- Established clinical history of Asthma for at least 1 year, and a history within the last 14 months (prior to screening) of asthma exacerbation due to presumed viral respiratory infections, which required asthma rescue medication treatment.
- The asthma subjects will be currently taking at least medium-dose or high-dose ICS defined as fluticasone at a dosage of at least >264 µg daily and may be taking other asthma medication preparations. The asthma subjects' medication regimen must be stable for at least 4 weeks before screening.
- Subjects will have at screening or within the last year, documented variable airway obstruction as indicated by an increase in FEV1 (>12%) to short acting bronchodilator, or positive methacholine challenge, or positive histamine challenge (PC20 <8 mg/mL).
- Upon presentation to the clinic with cold symptoms, subjects will be required to be randomized and treated within 48 hours of symptom onset and will be qualified for presumptive rhinovirus infection by:
Key exclusion criteria (4 listed)
- Subjects presenting to the clinic with a current severe asthma exacerbation will be excluded from randomization, as well as any subject with an additional underlying respiratory medical condition other than asthma such as COPD, cystic fibrosis, or chronic sinusitis, or any other uncontrolled clinically significant disease which would interfere with the assessment outcomes or subject safety.
- Female subjects must not be pregnant or breastfeeding. Females of childbearing potential must be willing to utilize a double barrier method of contraception, as defined in this protocol, regardless of any hormonal contraception they may be concomitantly receiving.
- Male subjects must agree to use a method of birth control defined in this protocol.
- The use of medications known to moderately or severely inhibit or induce cytochrome (CYP) 3A4 and 2C19 enzymes, or those known to be sensitive substrates (with a narrow therapeutic range) of these CYPs are restricted.
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 |
|---|---|---|
| VapendavirAlso: BTA798Vapendavir 264 mg twice daily | Drug | Vapendavir 264 mg |
| VapendavirAlso: BTA798Vapendavir 528 mg twice daily | Drug | Vapendavir 528 mg |
| PlaceboPlacebo twice daily | Drug | Placebo |
Primary outcome
Asthma Control Questionnaire-6 (ACQ-6)
Time frame: Baseline (Day 1) to Study Day 14
Least Square (LS) mean change from baseline (Day 1) to Study Day 14 in ACQ-6 total score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
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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.
Anna Novotney-Barry study director
Biota Pharmaceuticals, Inc.
62 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vapendavir in people with Asthma, run by Biota Pharmaceuticals, Inc. at 62 sites in 6 countries.
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 8 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 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States, Poland, Bulgaria, Czechia, Romania and 1 more country. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Asthma Control Questionnaire-6 (ACQ-6) (time frame: Baseline (Day 1) to Study Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2018.