RecruitingRhinovirus Infection

Trial Comparing the Safety and Efficacy of Two Different Oral VPV Doses With Placebo as Treatment for RV in Participants With COPD

Eligible age

40–85 yrs

Accepts

All genders

Locations

11 states

Healthy volunteers

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About this study

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.

Sponsor: Altesa Biosciences, Inc.

You may qualify if…

✓ If on stable COPD maintenance therapy this should be stable for at least 2 months prior to randomization. Changes allowed with Sponsor approval (i.e., change within same class due to financial considerations and clinically stable).
✓ Clinically stable with no other exacerbations or respiratory infections (viral or bacterial) within 2 months prior to randomization.
✓ The presence of RV (without a co-infection) at the time of randomization based on an approved molecular diagnostic test.
✓ To be randomized, participants must have at least 3 E-RS scores completed within the previous 35 days to establish a PSB.
✓ Exclusion
✓ Pregnant or nursing or expected to become pregnant during the study period. Experiencing a current/active or prior exacerbation within 2 months of the Screening Visit (these participants should be rescreened after the exacerbation has been resolved for two months).
✓ Participants with other primary causes of chronic airflow limitation:
✓ \- Including but not limited to: asthma alone (COPD with asthmatic features is acceptable), CF, bronchiolitis obliterans, fibrosis such as TB, IPF, non-CF bronchiectasis with multi-lobe involvement or other major respiratory diagnosis (e.g., allergic bronchopulmonary aspergillosis), etc.

You may not qualify if…

✕ It is already determined, based on the Investigator's clinical judgement, that the participant will likely need antibiotics and/or oral steroids at the Day 1 Randomization Visit.
✕ On or within 7 days prior to randomization, there is another active diagnosed infection with viral or bacterial pathogens (i.e., urinary tract infection, cellulitis, etc.) that requires treatment.