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

Asthma Clinical Trial

— SPIRITUS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02367313
• Other study ID #: BTA798-203
• Secondary ID: 2014-001785-95
• Status: Completed
• Phase: Phase 2
• Start date: February 2015
• Est. completion date: December 2016

Study information

• Verified date: May 2018
• Source: Vaxart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 455
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Infection

Intervention

Drug:
• Vapendavir
Vapendavir 264 mg twice daily
• Vapendavir
Vapendavir 528 mg twice daily
• Placebo
Placebo twice daily

Locations

Country	Name	City	State
Bulgaria	Biota Investigational site	Ruse
Bulgaria	Biota Investigational site	Sofia
Bulgaria	Biota Investigational site	Sofia
Bulgaria	Biota Investigational site	Sofia
Bulgaria	Biota Investigational site	Sofia
Bulgaria	Biota Investigational site	Stara Zagora
Czechia	Biota Investigational site	Jindrichuv Hradec
Czechia	Biota Investigational site	Kyjov
Czechia	Biota Investigational site	Lovosice
Czechia	Biota Investigational site	Melnik
Czechia	Biota Investigational site	Prague
Czechia	Biota Investigational site	Rokycany
Georgia	Biota Investigational site	Tbilisi
Georgia	Biota Investigational site	Tbilisi
Georgia	Biota Investigational site	Tbilisi
Poland	Biota Investigational site	Bialystok
Poland	Biota Investigational site	Kielce
Poland	Biota Investigational site	Krakow
Poland	Biota Investigational site	Lodz
Poland	Biota Investigational site	Lublin
Poland	Biota Investigational site	Skierniewice
Poland	Biota Investigational site	Warsaw
Poland	Biota Investigational site	Wroclaw
Poland	Biota Investigational site	Wroclaw
Romania	Biota Investigational site	Brasov
Romania	Biota Investigational site	Bucharest
Romania	Biota Investigational site	Craiova
Romania	Biota Investigational site	Mures
Romania	Biota Investigational site	Sibiu
United States	Biota Investigational site	Albuquerque	New Mexico
United States	Biota Investigational site	Bakersfield	California
United States	Biota Investigational site	Baltimore	Maryland
United States	Biota Investigational site	Bellevue	Nebraska
United States	Biota Investigational site	Birmingham	Alabama
United States	Biota Investigational site	Centennial	Colorado
United States	Biota Investigational site	Denver	Colorado
United States	Biota Investigational site	Fargo	North Dakota
United States	Biota Investigational site	Flagstaff	Arizona
United States	Biota Investigational site	Greenfield	Wisconsin
United States	Biota Investigational site	Hialeah	Florida
United States	Biota Investigational site	Houston	Texas
United States	Biota investigational site	Las Vegas	Nevada
United States	Biota Investigational site	Los Angeles	California
United States	Biota Investigational site	Medford	Oregon
United States	Biota Investigational site	Middleburg	Ohio
United States	Biota Investigational site	New Port Richey	Florida
United States	Biota Investigational site	Ocean City	New Jersey
United States	Biota Investigation site	Oklahoma City	Oklahoma
United States	Biota Investigational site	Orange	California
United States	Biota Investigational site	Oviedo	Florida
United States	Biota Investigation site	Palmetto Bay	Florida
United States	Biota Investigational site	Portland	Oregon
United States	Biota Investigational site	Raleigh	North Carolina
United States	Biota Investigational site	Rockville Centre	New York
United States	Biota Investigational site	Saint Louis	Missouri
United States	Biota Investigational Site	San Jose	California
United States	Biota Investigational site	Seattle	Washington
United States	Biota Investigational site	Stockton	California
United States	Biota Investigational site	Tallahassee	Florida
United States	Biota Investigational site	Toledo	Ohio
United States	Biota Investigational site	Twin Falls	Idaho
United States	Biota Investigational site	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Biota Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  Georgia,  Poland,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Questionnaire-6 (ACQ-6)	Least Square (LS) mean change from baseline (Day 1) to Study Day 14 in ACQ-6 total score	Baseline (Day 1) to Study Day 14