Compare the safety and efficacy of two different oral vapendavir doses with placebo in order to determine the appropriate dose of vapendavir to reduce the severity and/or duration of respiratory symptoms associated with RV infections in patients with COPD.
Increase frequency or dose of beta agonist(s), oxygen, breathing treatments or chronic COPD medications (Mild Exacerbation)
Use of oral or systemic steroids (Moderate Exacerbation), or
Use of Antibiotics (Moderate Exacerbation), or
Emergency room visit or hospitalization (Severe Exacerbation). CAT score ≥10 at screening. Able to comply with all study requirements, including the use of a mobile application to complete daily PROs, perform nasal swabs at home, and able to assess when they have cold symptoms.
None
Parallel
VPV 1000 mg
DrugVapendavir 1000 mg
VPV 500 mg
DrugVapendavir 500 mg
Placebo
Other interventionPlacebo
Evaluating Respiratory Symptoms (E-RS)
11-item E RS collected as part of the 14-item EXAcerbations of Chronic pulmonary disease Tool (EXACT PRO®) scale, with data from the additional 3 items from the EXACT PRO scale used for exploratory purposes only. The PSB will be calculated as the mean of the E-RS scores collected in the -35 to -6 days prior to RV symptom onset. If the E-RS score has not returned to PSB at the time of Day 28 Visit, the participant will complete the E-RS daily until Day 42. The questions are asked about how the participant feels today and will be collected at night.
Patient Global Impression of Severity (PGIS)
The PGIS is one question, 'Please rate the overall severity of your respiratory symptoms today? (none, mild, moderate, severe, very severe).'
Wisconsin Upper Respiratory Symptom Survey - 11
The questions are asked about how the participant feels today or within the last 24 hours. The questionnaire will be completed at night.
Change from Baseline in Respiratory System Resistance at 5 Hz (R5) Measured by Oscillometry
Respiratory system resistance at an oscillation frequency of 5 Hz, measured by oscillometry during unforced tidal breathing. R5 reflects total respiratory system resistance and is a measure of overall airway caliber. Values are reported as the mean of at least three technically acceptable measurements, performed according to the 2020 European Respiratory Society / American Thoracic Society technical standards for respiratory oscillometry. Unit of measure: cmH₂O·s/L.
Change from Baseline in Respiratory System Resistance at 20 Hz (R20) Measured by Oscillometry
Respiratory system resistance at an oscillation frequency of 20 Hz, measured by oscillometry during unforced tidal breathing. R20 predominantly reflects large/central airway resistance, as higher-frequency oscillations do not penetrate the peripheral airways. Values are reported as the mean of at least three technically acceptable measurements, performed according to the 2020 European Respiratory Society / American Thoracic Society technical standards for respiratory oscillometry. Unit of measure: cmH₂O·s/L.
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