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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. )

Tracking Information
First Submitted Date  ICMJE February 13, 2015
First Posted Date  ICMJE February 20, 2015
Last Update Posted Date June 1, 2018
Study Start Date  ICMJE February 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study of Vapendavir in Asthmatic Adults With Symptomatic Human Rhinovirus Infection
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: Vapendavir
    Vapendavir 264 mg twice daily
    Other Name: BTA798
  • Drug: Vapendavir
    Vapendavir 528 mg twice daily
    Other Name: BTA798
  • Drug: Placebo
    Placebo twice daily
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Vapendavir 264 mg
    Vapendavir 264 mg and matching placebo
    Intervention: Drug: Vapendavir
  • Active Comparator: Vapendavir 528 mg
    Vapendavir 528 mg and matching placebo
    Intervention: Drug: Vapendavir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 7, 2016)
455
Original Estimated Enrollment  ICMJE
 (submitted: February 13, 2015)
480
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Czechia,   Georgia,   Poland,   Romania,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02367313
Other Study ID Numbers  ICMJE BTA798-203
2014-001785-95 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vaxart ( Biota Pharmaceuticals, Inc. )
Study Sponsor  ICMJE Biota Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Anna Novotney-Barry Biota Pharmaceuticals, Inc.
PRS Account Vaxart
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP