Clinical trial NCT02367313: A Phase 2 Study of Vapendavir in Asthmatic Adults With Symptomatic Human Rhinovirus Infection
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Symptomatic Human Rhinovirus Infection
Moderate to Severe Asthma
Antiviral
Cold
Aviragen Therapeutics, Inc.
Aviragen Therapeutics
Aviragen
Lead sponsor: Vaxart
Sponsor class: INDUSTRY
First posted: 2015-02-20
Enrollment: 455
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Asthma Control Questionnaire-6 (ACQ-6)
timeFrame: Baseline (Day 1) to Study Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Biota Investigational site
state: Alabama
city: Flagstaff
country: United States
facility: Biota Investigational site
state: Arizona
city: Bakersfield
country: United States
facility: Biota Investigational site
state: California
city: Los Angeles
country: United States
facility: Biota Investigational site
state: California
city: Orange
country: United States
facility: Biota Investigational site
state: California
city: San Jose
country: United States
facility: Biota Investigational Site
state: California
city: Stockton
country: United States
facility: Biota Investigational site
state: California
city: Centennial
country: United States
facility: Biota Investigational site
state: Colorado
city: Denver
country: United States
facility: Biota Investigational site
state: Colorado
city: Hialeah
country: United States
facility: Biota Investigational site
state: Florida
city: New Port Richey
country: United States
facility: Biota Investigational site
state: Florida
city: Oviedo
country: United States
facility: Biota Investigational site
state: Florida
city: Palmetto Bay
country: United States
facility: Biota Investigation site
state: Florida
city: Tallahassee
country: United States
facility: Biota Investigational site
state: Florida
city: Twin Falls
country: United States
facility: Biota Investigational site
state: Idaho
city: Baltimore
country: United States
facility: Biota Investigational site
state: Maryland
city: Saint Louis
country: United States
facility: Biota Investigational site
state: Missouri
city: Bellevue
country: United States
facility: Biota Investigational site
state: Nebraska
city: Las Vegas
country: United States
facility: Biota investigational site
state: Nevada
city: Ocean City
country: United States
facility: Biota Investigational site
state: New Jersey
city: Albuquerque
country: United States
facility: Biota Investigational site
state: New Mexico
city: Rockville Centre
country: United States
facility: Biota Investigational site
state: New York
city: Raleigh
country: United States
facility: Biota Investigational site
state: North Carolina
city: Fargo
country: United States
facility: Biota Investigational site
state: North Dakota
city: Middleburg
country: United States
facility: Biota Investigational site
state: Ohio
city: Toledo
country: United States
facility: Biota Investigational site
state: Ohio
city: Oklahoma City
country: United States
facility: Biota Investigation site
state: Oklahoma
city: Medford
country: United States
facility: Biota Investigational site
state: Oregon
city: Portland
country: United States
facility: Biota Investigational site
state: Oregon
city: Warwick
country: United States
facility: Biota Investigational site
state: Rhode Island
city: Houston
country: United States
facility: Biota Investigational site
state: Texas
city: Seattle
country: United States
facility: Biota Investigational site
state: Washington
city: Greenfield
country: United States
facility: Biota Investigational site
state: Wisconsin
city: Ruse
country: Bulgaria
facility: Biota Investigational site
city: Sofia
country: Bulgaria
facility: Biota Investigational site
city: Sofia
country: Bulgaria
facility: Biota Investigational site
city: Sofia
country: Bulgaria
facility: Biota Investigational site
city: Sofia
country: Bulgaria
facility: Biota Investigational site
city: Stara Zagora
country: Bulgaria
facility: Biota Investigational site
city: Jindrichuv Hradec
country: Czechia
facility: Biota Investigational site
city: Kyjov
country: Czechia
facility: Biota Investigational site
city: Lovosice
country: Czechia
facility: Biota Investigational site
city: Melnik
country: Czechia
facility: Biota Investigational site
city: Prague
country: Czechia
facility: Biota Investigational site
city: Rokycany
country: Czechia
facility: Biota Investigational site
city: Tbilisi
country: Georgia
facility: Biota Investigational site
city: Tbilisi
country: Georgia
facility: Biota Investigational site
city: Tbilisi
country: Georgia
facility: Biota Investigational site
city: Bialystok
country: Poland
facility: Biota Investigational site
city: Kielce
country: Poland
facility: Biota Investigational site
city: Krakow
country: Poland
facility: Biota Investigational site
city: Lodz
country: Poland
facility: Biota Investigational site
city: Lublin
country: Poland
facility: Biota Investigational site
city: Skierniewice
country: Poland
facility: Biota Investigational site
city: Warsaw
country: Poland
facility: Biota Investigational site
city: Wroclaw
country: Poland
facility: Biota Investigational site
city: Wroclaw
country: Poland
facility: Biota Investigational site
city: Brasov
country: Romania
facility: Biota Investigational site
city: Bucharest
country: Romania
facility: Biota Investigational site
city: Craiova
country: Romania
facility: Biota Investigational site
city: Mures
country: Romania
facility: Biota Investigational site
city: Sibiu
country: Romania
facility: Biota Investigational site
Study officials:
affiliation: Biota Pharmaceuticals, Inc.
name: Anna Novotney-Barry
role: STUDY_DIRECTOR
References: