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A Phase 2 Study of Vapendavir in Asthmatic Adults With Symptomatic Human Rhinovirus Infection (SPIRITUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02367313
Recruitment Status : Completed
First Posted : February 20, 2015
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Vaxart ( Biota Pharmaceuticals, Inc. )

Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Vapendavir Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 455 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : February 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo twice daily

Active Comparator: Vapendavir 264 mg
Vapendavir 264 mg and matching placebo
Drug: Vapendavir
Vapendavir 264 mg twice daily
Other Name: BTA798

Active Comparator: Vapendavir 528 mg
Vapendavir 528 mg and matching placebo
Drug: Vapendavir
Vapendavir 528 mg twice daily
Other Name: BTA798




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Moderate and severe male and female asthma subjects aged 18 to 75 years, (inclusive)
  2. 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.
  3. 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.
  4. 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).
  5. 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:

    1. 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.
    2. subjects must also have a minimum total symptom score on the Day 1 WURSS-21 of 20 points.
    3. 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.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Male subjects must agree to use a method of birth control defined in this protocol.
  4. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02367313


Locations
Show Show 62 study locations
Sponsors and Collaborators
Biota Pharmaceuticals, Inc.
Investigators
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Study Director: Anna Novotney-Barry Biota Pharmaceuticals, Inc.

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Responsible Party: Biota Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02367313    
Other Study ID Numbers: BTA798-203
2014-001785-95 ( EudraCT Number )
First Posted: February 20, 2015    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Keywords provided by Vaxart ( Biota Pharmaceuticals, Inc. ):
Symptomatic Human Rhinovirus Infection
Moderate to Severe Asthma
Antiviral
Cold
Aviragen Therapeutics, Inc.
Aviragen Therapeutics
Aviragen
Additional relevant MeSH terms:
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Infection
Coal Tar
Keratolytic Agents
Dermatologic Agents