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

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.