180 Participants NeededMy employer runs this trial

Vapendavir for Common Cold

(Cardinal COPD Trial)

Recruiting at 45 trial locations
KF
Overseen ByKaren Fusaro
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Altesa Biosciences, Inc.
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of two different doses of an oral medication called vapendavir compared to a placebo for treating the common cold in people with COPD, a lung condition causing breathing difficulties. Researchers will divide participants into three groups to receive either a high dose, a low dose, or a placebo to determine which dose best reduces cold symptoms. Ideal candidates have COPD, have experienced at least one flare-up in the past year, and interact with others at least twice a week. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on stable COPD maintenance therapy, it should be stable for at least 2 months before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that vapendavir is generally safe, as tested in earlier studies. In trials with asthma patients, doses of 264 mg and 528 mg taken twice daily were well-tolerated, and participants had lower levels of the virus in their bodies.

Another study found that vapendavir alleviated symptoms of the common cold caused by rhinovirus. Participants reported milder symptoms and a shorter duration of illness. The treatment was considered safe, with manageable side effects.

These findings suggest that vapendavir is generally well-tolerated. However, individual reactions can vary. Consulting a healthcare provider before joining a clinical trial is always advisable.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about Vapendavir because it offers a potentially more targeted approach to treating the common cold than current options like decongestants and antihistamines. Unlike these treatments, which mainly focus on alleviating symptoms, Vapendavir works by directly inhibiting the replication of rhinoviruses, the most common cause of colds. This antiviral action could lead to faster relief and potentially shorter illness duration. Additionally, the availability of two dosing options—1000 mg and 500 mg—allows researchers to explore the most effective and safest dose for patients.

What evidence suggests that this trial's treatments could be effective for the common cold?

Research has shown that vapendavir effectively reduces common cold symptoms, particularly those caused by rhinovirus, in individuals with COPD. Studies have found that vapendavir improves both upper and lower respiratory symptoms and can shorten the illness duration. In this trial, participants will receive either 1000 mg or 500 mg doses of vapendavir, or a placebo, to evaluate its effectiveness. Specifically, in patients with COPD, vapendavir eased breathing problems and sped up recovery from rhinovirus infections. Evidence also suggests that vapendavir works well against all three types of rhinovirus, the main causes of the common cold. This treatment appears promising for managing cold symptoms in people with breathing issues.12356

Are You a Good Fit for This Trial?

This trial is for people with COPD who have a common cold caused by RV (rhinovirus). Participants should be adults diagnosed with COPD and currently experiencing respiratory symptoms from a cold.

Inclusion Criteria

Able to comply with all study requirements including use of mobile app for daily PROs, nasal swabs at home, and symptom assessment
CAT score ≥10 at screening
I have had at least one COPD flare-up needing extra treatment in the past year.
See 5 more

Exclusion Criteria

My COPD treatment has not changed in the last 2 months.
Presence of RV without co-infection at randomization based on approved molecular diagnostic test
Must have at least 3 E-RS scores completed within previous 35 days to establish a PSB for randomization
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive either 1000 mg or 500 mg of VPV or placebo daily for 7 days

1 week
Day 1 visit (in-person), subsequent doses at home

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks
Day 3, Day 7, Day 14, Day 28, Day 42 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • VPV 1000 mg
  • VPV 500 mg

Trial Overview

The study compares two different doses of an oral drug called vapendavir (500 mg and 1000 mg) to a placebo. The goal is to see which dose works best at reducing the severity or length of cold symptoms in people with COPD.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Dosing Group 2 VPV 500 mgExperimental Treatment2 Interventions
Group II: Dosing Group 1 VPV 1000 mgExperimental Treatment1 Intervention
Group III: Dosing Group 3 PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Altesa Biosciences, Inc.

Lead Sponsor

Trials
3
Recruited
80+

Citations

Study Details | NCT07610395 | Trial Comparing the Safety ...

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 ...

RCT of Vapendavir in Patients With COPD and Human ...

Vapendavir (VPV) is a drug being developed to treat human rhinovirus (RV) infection, one virus responsible for the common cold.

Comparative analysis of the molecular mechanism of ... - PMC

Vapendavir significantly improves upper respiratory symptoms of naturally acquired rhinovirus infection in asthmatic adults: results of a phase 2 clinical trial ...

New Altesa BioSciences Data: Vapendavir Demonstrates ...

The Challenge study data demonstrated vapendavir improved upper and lower airway symptoms ... Results for Vapendavir at American Thoracic ...

From the “One-Molecule, One-Target, One-Disease” ...

A total of 14 male patients, ranging from 18 to 50 years, received 200, 500 (fasted or fed), 1000, or 2000 mg of drug. The study concluded that for 500 mg ...

New Altesa BioSciences Data: Vapendavir Demonstrates ...

The Challenge study data demonstrated vapendavir improved upper and lower airway symptoms, reduced illness duration and better maintained small ...