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

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT02367313

Run by

Biota Pharmaceuticals, Inc.

People needed

455

Starts

2015-02-01

Expected to finish

2016-12-01

Last updated by the study team

2018-06-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

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.

Where it is running

• Biota Investigational site — Flagstaff, Arizona, United States
• Biota Investigational site — Bakersfield, California, United States
• Biota Investigational site — Los Angeles, California, United States
• Biota Investigational site — Orange, California, United States
• Biota Investigational Site — San Jose, California, United States
• Biota Investigational site — Stockton, California, United States
• Biota Investigational site — Centennial, Colorado, United States
• Biota Investigational site — Denver, Colorado, United States
• Biota Investigational site — Hialeah, Florida, United States
• Biota Investigational site — New Port Richey, Florida, United States
• Biota Investigational site — Oviedo, Florida, United States
• Biota Investigation site — Palmetto Bay, Florida, United States
• Biota Investigational site — Tallahassee, Florida, United States
• Biota Investigational site — Twin Falls, Idaho, United States
• Biota Investigational site — Baltimore, Maryland, United States
• Biota Investigational site — St Louis, Missouri, United States
• Biota Investigational site — Bellevue, Nebraska, United States
• Biota investigational site — Las Vegas, Nevada, United States
• Biota Investigational site — Ocean City, New Jersey, United States
• Biota Investigational site — Albuquerque, New Mexico, United States
• Biota Investigational site — Rockville Centre, New York, United States
• Biota Investigational site — Raleigh, North Carolina, United States
• Biota Investigational site — Fargo, North Dakota, United States
• Biota Investigational site — Middleburg, Ohio, United States
• Biota Investigational site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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