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

August 10, 2026 updated by: Altesa Biosciences, Inc.

A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial Comparing the Safety and Efficacy of Two Different Oral Vapendavir (VPV) Doses With Placebo as Treatment for Rhinovirus (RV) in Participants With Chronic Obstructive Pulmonary Disease (COPD)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Recruiting
        • Velocity Clinical Research - Mobile
        • Contact:
          • Velocity Clinical Research - Mobile
    • Arizona
      • Tempe, Arizona, United States, 85281
        • Recruiting
        • AMR Clinical - Tempe
        • Contact:
          • AMR Clinical - Tempe
    • California
      • Inglewood, California, United States, 90301
        • Recruiting
        • 310 Clinical Research, LLC
        • Contact:
          • 310 Clinical Research, LLC
      • Newport Beach, California, United States, 92663
        • Recruiting
        • NewportNativeMD, Inc.
        • Contact:
          • NewportNativeMD, Inc.
      • San Diego, California, United States, 92120
        • Recruiting
        • Apex Clinical Research
        • Contact:
          • Apex Clinical Research
    • Florida
      • Bradenton, Florida, United States, 34209
        • Recruiting
        • Synergy Health
        • Contact:
          • Synergy Health
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Medquest Translational Sciences
        • Contact:
          • Medquest Translational Sciences
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • VM Clintrials
        • Contact:
          • VM Clintrials
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • Metropolitan Clinical Research Center
        • Contact:
          • Metropolitan Clinical Research Center
    • Georgia
      • East Point, Georgia, United States, 30344
        • Recruiting
        • Covenant Critical Pulmonary Care
        • Contact:
          • Covenant Critical Pulmonary Care
      • Snellville, Georgia, United States, 30078
        • Recruiting
        • Accelerated Clinical Trials, LLC
        • Contact:
          • Accelerated Clinical Trials, LLC
    • Illinois
      • Naperville, Illinois, United States, 60540
        • Recruiting
        • Bioluminux Clinical Research Illinois
        • Contact:
          • Bioluminux Clinical Research Illinois
    • Indiana
      • Valparaiso, Indiana, United States, 46383
        • Recruiting
        • Velocity Clinical Research - Valparaiso
        • Contact:
          • Velocity Clinical Research - Valparaiso
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Recruiting
        • AMR Clinical - Lexington
        • Contact:
          • AMR Clinical - Lexington
    • Maryland
      • Lutherville, Maryland, United States, 21093
        • Recruiting
        • Patient First Clinical Trials (PFCTRIALS)
        • Contact:
          • Patient First Clinical Trials (PFCTRIALS)
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Recruiting
        • Verexa Health
        • Contact:
          • Verexa Health
      • Troy, Michigan, United States, 48085
        • Recruiting
        • Oakland Medical Research
        • Contact:
          • Oakland Medical Research
    • New Jersey
      • Hamilton, New Jersey, United States, 08690
        • Recruiting
        • Bioluminux Clinical Research New Jersey
        • Contact:
          • Bioluminux Clinical Research New Jersey
    • New York
      • Binghamton, New York, United States, 13905
        • Recruiting
        • Velocity Clinical Research - Binghamton
        • Contact:
          • Velocity Clinical Research - Binghamton
      • Brooklyn, New York, United States, 11226
        • Recruiting
        • Brooklyn Clinical Research
        • Contact:
          • Brooklyn Clinical Research
    • North Carolina
      • Kings Mountain, North Carolina, United States, 28086
        • Recruiting
        • CRC Kings Mountain
        • Contact:
          • CRC Kings Mountain
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Recruiting
        • Remington-Davis, Inc.
        • Contact:
          • Remington-Davis, Inc.
      • Milford, Ohio, United States, 45150
        • Recruiting
        • Hometown Urgent Care - Milford
        • Contact:
          • Hometown Urgent Care - Milford
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Recruiting
        • Tekton Research
        • Contact:
          • Tekton Research
    • Oregon
      • Medford, Oregon, United States, 97504
        • Recruiting
        • Velocity Clinical Research - Medford
        • Contact:
          • Velocity Clinical Research - Medford
    • Pennsylvania
      • DuBois, Pennsylvania, United States, 15801
        • Recruiting
        • Clinical Research Associates of Central PA, LLC
        • Contact:
          • Clinical Research Associates of Central PA, LLC l
      • Pittsburgh, Pennsylvania, United States, 15423
        • Recruiting
        • Preferred Primary Care Physicians - St. Clair
        • Contact:
          • Preferred Primary Care Physicians - St. Clair
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Recruiting
        • Velocity Clinical Research - Anderson
        • Contact:
          • Velocity Clinical Research - Anderson
      • Rock Hill, South Carolina, United States, 29732
        • Recruiting
        • Clinical Research of Rock Hill
        • Contact:
          • Clinical Research of Rock Hill
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Velocity Clinical Research - Spartanburg
        • Contact:
          • Velocity Clinical Research - Spartanburg
      • Union, South Carolina, United States, 29379
        • Recruiting
        • Velocity Clinical Research - Union
        • Contact:
          • Velocity Clinical Research - Union
    • Texas
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Zenos Clinical Research, LLC
        • Contact:
          • Zenos Clinical Research, LLC
      • Kingwood, Texas, United States, 77339
        • Recruiting
        • Activian Clinical Research
        • Contact:
          • Activian Clinical Research
      • Lewisville, Texas, United States, 75057
        • Recruiting
        • Epic Clinical Research, LLC
        • Contact:
          • Epic Clinical Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion

Sign informed consent for study participation and medical records release (if needed).

Male or female age ≥40 years and ≤85 years at the time of signing the informed consent at Screening.

If sexually active and/or of child-bearing potential (both females and males), must agree to use a highly effective form of contraception at the time of randomization until 30 days (females) or 90 days (males) after the last dose. Female participants may not use hormonal birth control as a sole method. Participants will be asked to commit to this criterion at screening even though it does not need to be implemented until treatment is received. See Section 11.2 below.

Confirmed diagnosis of COPD, defined as chronic cough, sputum production, and/or dyspnea with airflow obstruction which is not fully reversible (that is, post bronchodilator FEV1/FVC ratio <0.70 and post bronchodilator FEV1 ≥20% and <80% of predicted normal value).

History of AECOPD with at least 1 documented AECOPD within 1 year of Screening.

  • AECOPD is defined as an event characterized by dyspnea and/or cough and increased sputum purulence/change in sputum color that worsens over several days, and requires at least one of the following for at least 2 days:
  • 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.

Interacts with people at least twice a week without a mask (e.g., grocery shopping, dinner with grandchildren, eating at a restaurant, going to the movies, etc.) or are living in a multigenerational home.

Inclusion criteria to be assessed only at Randomization:

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.

Any disorder, for example, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric impairment that is not medically stable, or other major physical impairment that is not considered by the investigator medically stable/controlled.

Participants with hepatitis B are excluded. Participants on a stable treatment for HIV can be permitted with permission from the medical monitor. Participants with hepatitis C should be treated and confirmed HCV RNA negative prior to enrollment. (Testing performed at the Screening Visit).

In the Investigator's opinion, the participant has any clinically significant laboratory abnormality including an abnormality that indicates clinically significant hematologic, hepatobiliary, or renal disease.

Presence of clinically significant out-of-range cardiac interval on the screening ECG including a QTcF > 450 msec (men) and a QTcF > 460 msec (women).

Medications or other non-medicinal products that could be impacted by CYP3A4, CYP2C8, or CYP2C19 induction and have serious complications for the participant within the treatment period.

Medications that are potent CYP2C8, CYP3A4 or CYP2C19 inducers that would reduce exposures of VPV.

Medications that are potent CYP2C8, CYP3A4, or CYP2C19 inhibitors that would increase exposures of VPV.

Medications that are substrates of MATE1, OAT3, P-gp, and BCRP for which elevated concentrations are associated with serious and/or life-threatening reactions.

Use of either of the following treatments:

  • Chronic oral/systemic steroids >10 mg per day (inhaled corticosteroids are permitted).
  • Continuous oxygen via nasal cannula of >2 L/min at the time of Screening or during the Asymptomatic Phase. (Participants on continuous oxygen may have the rate increased during physical exercise/ exertion or to cover any situationally induced decompensation, so long as the participant will resume a continuous rate of ≤2 L/min thereafter).

Participation in another investigational drug study within 5 half-lives prior to Screening and during the study is prohibited. This includes approved drugs being evaluated for a new indication. Observational studies are permitted.

Participants who have taken VPV in another clinical trial.

Exclusion criteria to be assessed only at Randomization:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: VPV 1000 mg
Vapendavir 1000 mg
Other Names:
  • Vapendavir
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.
Drug: VPV 1000 mg
Vapendavir 1000 mg
Other Names:
  • Vapendavir
Drug: VPV 500 mg
Vapendavir 500 mg
Other Names:
  • Vapendaivr
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
Other: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Baseline Period/Asymptomatic Phase: Daily for 12 weeks Treatment/Follow-Up Periods: Daily for up to 42 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Global Impression of Severity (PGIS)
Time Frame: Baseline Period/Asymptomatic Phase: Daily for 12 weeks Treatment/Follow-Up Periods: Daily for up to 42 days
The PGIS is one question, 'Please rate the overall severity of your respiratory symptoms today? (none, mild, moderate, severe, very severe).'
Baseline Period/Asymptomatic Phase: Daily for 12 weeks Treatment/Follow-Up Periods: Daily for up to 42 days
Wisconsin Upper Respiratory Symptom Survey - 11
Time Frame: Treatment/Follow-up Periods: Daily for 28 days
The questions are asked about how the participant feels today or within the last 24 hours. The questionnaire will be completed at night.
Treatment/Follow-up Periods: Daily for 28 days
Change from Baseline in Respiratory System Resistance at 5 Hz (R5) Measured by Oscillometry
Time Frame: Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42
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.
Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42
Change from Baseline in Respiratory System Resistance at 20 Hz (R20) Measured by Oscillometry
Time Frame: Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42
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.
Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42
Change from Baseline in Frequency Dependence of Resistance (R5-R20) Measured by Oscillometry
Time Frame: Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42
The difference between respiratory system resistance measured at 5 Hz and at 20 Hz (R5 minus R20), measured by oscillometry during unforced tidal breathing. R5-R20 is interpreted as an index of small airway dysfunction, with elevated values indicating heterogeneity of peripheral airway resistance. Values are calculated from the mean of at least three technically acceptable measurements at each frequency, performed according to the 2020 European Respiratory Society / American Thoracic Society technical standards for respiratory oscillometry. Unit of measure: cmH₂O·s/L.
Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42
Change from Baseline in Respiratory System Reactance at 5 Hz (X5) Measured by Oscillometry
Time Frame: Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42
Respiratory system reactance at an oscillation frequency of 5 Hz, measured by oscillometry during unforced tidal breathing. X5 represents the elastic and inertive properties of the respiratory system at low frequency and becomes more negative with increased peripheral airway obstruction or reduced lung compliance. 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.
Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42
Change from Baseline in Area Under the Reactance Curve (AX) Measured by Oscillometry
Time Frame: Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42
The integrated area of the reactance curve from 5 Hz to the resonant frequency, measured by oscillometry during unforced tidal breathing. AX reflects the total elastic and inertive load of the respiratory system and is a sensitive composite index of peripheral airway dysfunction. 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/L.
Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42
Change from Baseline in Resonant Frequency (Fres) Measured by Oscillometry
Time Frame: Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42
The oscillation frequency at which respiratory system reactance equals zero, measured by oscillometry during unforced tidal breathing. Fres represents the frequency at which the inertive and elastic forces of the respiratory system are equal in magnitude and opposite in direction; it shifts to higher frequencies with peripheral airway obstruction. 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: Hz.
Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42
Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1) - Absolute Value
Time Frame: Screening Visit, and Days 7, 14, 28 and 42
Forced expiratory volume in the first second of a maximal forced expiration following a full inspiration, measured by spirometry. FEV1 is a primary index of airflow obstruction. Values are reported as the highest acceptable value from at least three acceptable and two repeatable maneuvers, performed according to the 2019 European Respiratory Society / American Thoracic Society standards for spirometry. Unit of measure: liters.
Screening Visit, and Days 7, 14, 28 and 42
Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1) - Percent Predicted
Time Frame: Screening Visit, Day 7, Day 14, Day 28, Day 42
Forced expiratory volume in the first second expressed as a percentage of the predicted value for the participant's age, sex, height, and ethnicity using the Global Lung Function Initiative (GLI-2012) reference equations. Measured by spirometry according to the 2019 European Respiratory Society / American Thoracic Society standards. Unit of measure: percent of predicted (%).
Screening Visit, Day 7, Day 14, Day 28, Day 42
Change from Baseline in Forced Vital Capacity (FVC) - Absolute Value
Time Frame: Screening Visit, Day 7, Day 14, Day 28, Day 42
Forced vital capacity, defined as the maximum volume of air exhaled with maximally forced effort from a position of maximal inspiration, measured by spirometry. Values are reported as the highest acceptable value from at least three acceptable and two repeatable maneuvers, performed according to the 2019 European Respiratory Society / American Thoracic Society standards for spirometry. Unit of measure: liters.
Screening Visit, Day 7, Day 14, Day 28, Day 42
Change from Baseline in Forced Vital Capacity (FVC) - Percent Predicted
Time Frame: Screening Visit, Day 7, Day 14, Day 28, Day 42
Forced vital capacity expressed as a percentage of the predicted value for the participant's age, sex, height, and ethnicity using the Global Lung Function Initiative (GLI-2012) reference equations. Measured by spirometry according to the 2019 European Respiratory Society / American Thoracic Society standards. Unit of measure: percent of predicted (%).
Screening Visit, Day 7, Day 14, Day 28, Day 42
Change from Baseline in FEV1/FVC Ratio
Time Frame: Screening Visit, Day 7, Day 14, Day 28, Day 42
The ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC), calculated from the highest acceptable FEV1 and FVC obtained during the same testing session. The FEV1/FVC ratio is the principal spirometric criterion used to identify airflow obstruction. Measured by spirometry according to the 2019 European Respiratory Society / American Thoracic Society standards. Unit of measure: ratio.
Screening Visit, Day 7, Day 14, Day 28, Day 42
Change from Baseline in Peak Expiratory Flow (PEF) - Absolute Value
Time Frame: Screening Visit, Day 7, Day 14, Day 28, Day 42
Peak expiratory flow, defined as the highest flow achieved during a maximally forced expiration starting from a position of maximal inspiration, measured by spirometry. Values are reported as the highest acceptable value from at least three acceptable and two repeatable maneuvers, performed according to the 2019 European Respiratory Society / American Thoracic Society standards for spirometry. Unit of measure: liters per minute (L/min).
Screening Visit, Day 7, Day 14, Day 28, Day 42
Change from Baseline in Peak Expiratory Flow (PEF) - Percent Predicted
Time Frame: Screening Visit, Day 7, Day 14, Day 28, Day 42
Peak expiratory flow expressed as a percentage of the predicted value for the participant's age, sex, height, and ethnicity using the Global Lung Function Initiative (GLI-2012) reference equations. Measured by spirometry according to the 2019 European Respiratory Society / American Thoracic Society standards. Unit of measure: percent of predicted (%).
Screening Visit, Day 7, Day 14, Day 28, Day 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Altesa Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2026

Primary Completion (Estimated)

November 15, 2027

Study Completion (Estimated)

November 15, 2027

Study Registration Dates

First Submitted

May 12, 2026

First Submitted That Met QC Criteria

May 22, 2026

First Posted (Actual)

May 28, 2026

Study Record Updates

Last Update Posted (Actual)

August 12, 2026

Last Update Submitted That Met QC Criteria

August 10, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALT-VPV-203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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