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

Conditions

• Rhinovirus Infection

Eligibility Criteria

Sex

ALL

Age

40 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• VPV 1000 mg — DRUG
  Vapendavir 1000 mg
• VPV 500 mg — DRUG
  Vapendavir 500 mg
• Placebo — OTHER
  Placebo

Study Details

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.

Key Dates

Start date

May 1, 2026

Status verified

May 2026

Primary completion

Nov 15, 2027

Completion

Nov 15, 2027

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dosing Group 1 VPV 1000 mg
  The first dose of 1,000 mg VPV will be taken at the study site with food once the Day 1 visit is completed. The second dose of 1,000 mg VPV will be taken at home the following morning with food. The subsequent 1,000 mg doses will be taken every 24 hours with food from the time of the second dose for a total of 7 doses.
• Experimental: Dosing Group 2 VPV 500 mg
  The first dose of 1,000 mg VPV will be taken at the study site with food once the Day 1 visit is completed. The second dose of 500 mg VPV will be taken at home the following morning with food. The subsequent 500 mg doses will be taken every 24 hours with food from the time of the second dose for a total of 7 doses.
• Placebo Comparator: Dosing Group 3 Placebo
  The first dose of placebo will be taken at the study site with food once the Day 1 visit is completed. The second dose of placebo will be taken at home the following morning with food. The subsequent placebo doses will be taken every 24 hours with food from the time of the second dose for a total of 7 doses

Primary Outcome Measure

Evaluating Respiratory Symptoms (E-RS) [ Time Frame: Baseline Period/Asymptomatic Phase: Daily for 12 weeks Treatment/Follow-Up Periods: Daily for up to 42 days ]

Central Contacts

• Karen Fusaro
  610-242-0903
  [email protected]

Locations (14)

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