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

NCT02367313 | Completed Phase 2

• 2 other identifiers: BTA798-2032014-001785-95
• Study Type: interventional
• Target: 455
• Locations: 6 countries
• Sites: 62

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.

Conditions

Asthma

Keywords

Symptomatic Human Rhinovirus Infection; Moderate to Severe Asthma; Antiviral; Cold; Aviragen Therapeutics, Inc.; Aviragen Therapeutics; Aviragen

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Vapendavir 264 mg

ACTIVE COMPARATOR

Vapendavir 264 mg and matching placebo

Drug: Vapendavir

Vapendavir 528 mg

ACTIVE COMPARATOR

Vapendavir 528 mg and matching placebo

Drug: Vapendavir

Interventions

Vapendavir DRUG

Vapendavir 264 mg twice daily

Also known as: BTA798

Vapendavir 264 mg

Placebo DRUG

Placebo twice daily

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biota Pharmaceuticals, Inc.: lead

Study Sites (62)

Biota Investigational site

Birmingham, Alabama, 35209, United States

Location

Biota Investigational site

Flagstaff, Arizona, 86001, United States

Location

Biota Investigational site

Bakersfield, California, 93301, United States

Location

Biota Investigational site

Los Angeles, California, 90025, United States

Location

Biota Investigational site

Orange, California, 92868, United States

Location

Biota Investigational Site

San Jose, California, 95117, United States

Location

Biota Investigational site

Stockton, California, 95207, United States

Location

Biota Investigational site

Centennial, Colorado, 80112, United States

Location

Biota Investigational site

Denver, Colorado, 80230, United States

Location

Biota Investigational site

Hialeah, Florida, 33016, United States

Location

Biota Investigational site

New Port Richey, Florida, 34653, United States

Location

Biota Investigational site

Oviedo, Florida, 32765, United States

Location

Biota Investigation site

Palmetto Bay, Florida, 33157, United States

Location

Biota Investigational site

Tallahassee, Florida, 32308, United States

Location

Biota Investigational site

Twin Falls, Idaho, 83301, United States

Location

Biota Investigational site

Baltimore, Maryland, 21236, United States

Location

Biota Investigational site

St Louis, Missouri, 63141, United States

Location

Biota Investigational site

Bellevue, Nebraska, 68123, United States

Location

Biota investigational site

Las Vegas, Nevada, 89146, United States

Location

Biota Investigational site

Ocean City, New Jersey, 07712, United States

Location

Biota Investigational site

Albuquerque, New Mexico, 87102, United States

Location

Biota Investigational site

Rockville Centre, New York, 11570, United States

Location

Biota Investigational site

Raleigh, North Carolina, 27607, United States

Location

Biota Investigational site

Fargo, North Dakota, 58103, United States

Location

Biota Investigational site

Middleburg, Ohio, 44310, United States

Location

Biota Investigational site

Toledo, Ohio, 43617, United States

Location

Biota Investigation site

Oklahoma City, Oklahoma, 73120, United States

Location

Biota Investigational site

Medford, Oregon, 97504, United States

Location

Biota Investigational site

Portland, Oregon, 97202, United States

Location

Biota Investigational site

Warwick, Rhode Island, 02886, United States

Location

Biota Investigational site

Houston, Texas, 77055, United States

Location

Biota Investigational site

Seattle, Washington, 98115, United States

Location

Biota Investigational site

Greenfield, Wisconsin, 53228, United States

Location

Biota Investigational site

Rousse, 7002, Bulgaria

Location

Biota Investigational site

Sofia, 1202, Bulgaria

Location

Biota Investigational site

Sofia, 1407, Bulgaria

Location

Biota Investigational site

Sofia, 1606, Bulgaria

Location

Biota Investigational site

Sofia, 1618, Bulgaria

Location

Biota Investigational site

Stara Zagora, 6000, Bulgaria

Location

Biota Investigational site

Jindřichův Hradec, 37701, Czechia

Location

Biota Investigational site

Kyjov, 69733, Czechia

Location

Biota Investigational site

Lovosice, 41002, Czechia

Location

Biota Investigational site

Mělník, 27601, Czechia

Location

Biota Investigational site

Prague, 18200, Czechia

Location

Biota Investigational site

Rokycany, 33722, Czechia

Location

Biota Investigational site

Tbilisi, 0102, Georgia

Location

Biota Investigational site

Tbilisi, 0159, Georgia

Location

Biota Investigational site

Tbilisi, 0186, Georgia

Location

Biota Investigational site

Bialystok, 15-044, Poland

Location

Biota Investigational site

Kielce, 25-734, Poland

Location

Biota Investigational site

Krakow, 31-023, Poland

Location

Biota Investigational site

Lodz, 90-153, Poland

Location

Biota Investigational site

Lublin, 20-552, Poland

Location

Biota Investigational site

Skierniewice, 96-100, Poland

Location

Biota Investigational site

Warsaw, 01-868, Poland

Location

Biota Investigational site

Wroclaw, 50-044, Poland

Location

Biota Investigational site

Wroclaw, 51-162, Poland

Location

Biota Investigational site

Brasov, 500112, Romania

Location

Biota Investigational site

Bucharest, 020671, Romania

Location

Biota Investigational site

Craiova, 200446, Romania

Location

Biota Investigational site

Mures, 547530, Romania

Location

Biota Investigational site

Sibiu, 550360, Romania

Location

MeSH Terms

Conditions

Asthma; Common Cold

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases

Study Officials

• Anna Novotney-Barry

  Biota Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: February 20, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 1, 2018

Record last verified: 2018-05

Locations

PL (9); US (33); BU (6); RO (5); GE (3); CZ (6)