Vapendavir for Common Cold
(Cardinal COPD 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.12345Why 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either 1000 mg or 500 mg of VPV or placebo daily for 7 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
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.
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.
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Altesa Biosciences, Inc.
Lead Sponsor
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 ...
2.
ctv.veeva.com
ctv.veeva.com/study/rct-of-vapendavir-in-patients-with-copd-and-human-rhinovirus-enterovirus-upper-respiratory-infectionRCT 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 ...
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