Rhinovirus InfectionPhase 2Cardinal COPDNCT07610395
Trial Comparing the Safety and Efficacy of Two Different Oral VPV Doses With Placebo as Treatment for RV in Participants With COPD
A Phase 2 study testing VPV 1000 mg and VPV 500 mg in people with Rhinovirus Infection, run by Altesa Biosciences, Inc. at 46 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Rhinovirus Infection
- What is being tested?
- VPV 1000 mg and VPV 500 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 46 sitesin 2 countries
- Study dates
- 1 May 2026to 15 Nov 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 15Show fewer
- 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.
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
- 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.
Trial locations and contacts
46 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
46 sites in 2 countries
United States37 sites, 29 recruiting
- Recruiting
Velocity Clinical Research - Anderson
Anderson, South Carolina, 29621
Velocity Clinical Research - Anderson
- Recruiting
Velocity Clinical Research - Binghamton
Binghamton, New York, 13905
Velocity Clinical Research - Binghamton
- Recruiting
Synergy Health
Bradenton, Florida, 34209
Synergy Health
- Recruiting
Brooklyn Clinical Research
Brooklyn, New York, 11226
Brooklyn Clinical Research
- Recruiting
Remington-Davis, Inc.
Columbus, Ohio, 43215
Remington-Davis, Inc.
- Active, not recruiting
Zenos Clinical Research, LLC
Dallas, Texas, 75230
- Recruiting
Verexa Health
Dearborn, Michigan, 48126
Verexa Health
- Recruiting
Clinical Research Associates of Central PA, LLC
DuBois, Pennsylvania, 15801
Clinical Research Associates of Central PA, LLC l
- Recruiting
Covenant Critical Pulmonary Care
East Point, Georgia, 30344
Covenant Critical Pulmonary Care
- Recruiting
Tekton Research
Edmond, Oklahoma, 73013
Tekton Research
- Recruiting
Bioluminux Clinical Research New Jersey
Hamilton, New Jersey, 08690
Bioluminux Clinical Research New Jersey
- Active, not recruiting
310 Clinical Research, LLC
Inglewood, California, 90301
- Recruiting
CRC Kings Mountain
Kings Mountain, North Carolina, 28086
CRC Kings Mountain
- Active, not recruiting
Activian Clinical Research - Kingwood
Kingwood, Texas, 77339
- Active, not recruiting
AMR Clinical - Las Vegas
Las Vegas, Nevada, 89119
- Active, not recruiting
Epic Clinical Research, LLC
Lewisville, Texas, 75057
- Active, not recruiting
AMR Clinical - Lexington
Lexington, Kentucky, 40509
- Recruiting
Patient First Clinical Trials (PFCTRIALS)
Lutherville, Maryland, 21093
Patient First Clinical Trials (PFCTRIALS)
- Recruiting
Velocity Clinical Research - Medford
Medford, Oregon, 97504
Velocity Clinical Research - Medford
- Recruiting
VM Clintrials
Miami Lakes, Florida, 33014
VM Clintrials
- Recruiting
Medquest Translational Sciences
Miami Lakes, Florida, 33016
Medquest Translational Sciences
- Recruiting
Hometown Urgent Care - Milford
Milford, Ohio, 45150
Hometown Urgent Care - Milford
- Recruiting
Velocity Clinical Research - Mobile
Mobile, Alabama, 36608
Velocity Clinical Research - Mobile
- Recruiting
Bioluminux Clinical Research Illinois
Naperville, Illinois, 60540
Bioluminux Clinical Research Illinois
- Recruiting
NewportNativeMD, Inc.
Newport Beach, California, 92663
NewportNativeMD, Inc.
- Recruiting
Preferred Primary Care Physicians - St. Clair
Pittsburgh, Pennsylvania, 15423
Preferred Primary Care Physicians - St. Clair
- Recruiting
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732
Clinical Research of Rock Hill
- Recruiting
Apex Clinical Research
San Diego, California, 92120
Apex Clinical Research
- Recruiting
Guthrie Medical Group, PC
Sayre, Pennsylvania, 18840
Guthrie Medical Group, PC
- Active, not recruiting
Accelerated Clinical Trials
Snellville, Georgia, 30078
- Recruiting
Velocity Clinical Research - Spartanburg
Spartanburg, South Carolina, 29303
Velocity Clinical Research - Spartanburg
- Recruiting
Metropolitan Clinical Research Center
Tamarac, Florida, 33321
Metropolitan Clinical Research Center
- Active, not recruiting
AMR Clinical - Tempe
Tempe, Arizona, 85281
- Recruiting
Activian Clinical Research - Tomball
Tomball, Texas, 77375
Activian Clinical Research - Tomball
- Recruiting
Oakland Medical Research
Troy, Michigan, 48085
Oakland Medical Research
- Recruiting
Velocity Clinical Research - Union
Union, South Carolina, 29379
Velocity Clinical Research - Union
- Recruiting
Velocity Clinical Research - Valparaiso
Valparaiso, Indiana, 46383
Velocity Clinical Research - Valparaiso
United Kingdom9 sites, 9 recruiting
- Recruiting
FutureMeds Liverpool
Bromborough, CH62 6EE
FutureMeds Liverpool
- Recruiting
FutureMeds Glasgow
Glasgow, G20 7BE
FutureMeds Glasgow
- Recruiting
Imperial Clinical Respiratory Research Unit
London, NW1 0NH
Imperial Clinical Respiratory Research Unit
- Recruiting
FutureMeds London
London, NW10 2PB
FutureMeds London
- Recruiting
Clinicalysis
London, RM1 1BH
CLINICALYSIS
- Recruiting
ProMed Innovations Clinical Research
London, SE6 4LF
ProMed Innovations Clinical Research
- Recruiting
Imperial College Healthcare NHS Trust
London, W12 0HS
Imperial College Healthcare NHS Trust
- Recruiting
Bioluminux Clinical Research Milton Keynes
Milton Keynes, MK15 0DU
Bioluminux Clinical Research Milton Keynes
- Recruiting
Bioluminux Clinical Research Wolverhampton
Wolverhampton, WV9 5HB
Bioluminux Clinical Research Wolverhampton
About this study
Official title: 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.
- Conditions
- Rhinovirus Infection
- Being tested
- VPV 1000 mg, VPV 500 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPV 1000 mgDrug
Also called Vapendavir
Vapendavir 1000 mg
VPV 500 mgDrug
Also called Vapendaivr
Vapendavir 500 mg
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Dosing Group 1 VPV 1000 mg | Experimental | 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. Receives: Drug: VPV 1000 mg |
| Dosing Group 2 VPV 500 mg | Experimental | 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. Receives: Drug: VPV 1000 mg; Drug: VPV 500 mg |
| Dosing Group 3 Placebo | Placebo comparator | 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating Respiratory Symptoms (E-RS)
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.
Measured: Baseline Period/Asymptomatic Phase: Daily for 12 weeks Treatment/Follow-Up Periods: Daily for up to 42 days
Secondary outcomes (15)
Patient Global Impression of Severity (PGIS)
The PGIS is one question, 'Please rate the overall severity of your respiratory symptoms today? (none, mild, moderate, severe, very severe).'
Measured: Baseline Period/Asymptomatic Phase: Daily for 12 weeks Treatment/Follow-Up Periods: Daily for up to 42 days
Wisconsin Upper Respiratory Symptom Survey - 11
The questions are asked about how the participant feels today or within the last 24 hours. The questionnaire will be completed at night.
Measured: Treatment/Follow-up Periods: Daily for 28 days
Change from Baseline in Respiratory System Resistance at 5 Hz (R5) Measured by Oscillometry
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42
Change from Baseline in Resonant Frequency (Fres) Measured by Oscillometry
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.
Measured: 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
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.
Measured: Screening Visit, and Days 7, 14, 28 and 42
Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1) - Percent Predicted
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 (%).
Measured: Screening Visit, Day 7, Day 14, Day 28, Day 42
Change from Baseline in Forced Vital Capacity (FVC) - Absolute Value
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.
Measured: Screening Visit, Day 7, Day 14, Day 28, Day 42
Change from Baseline in Forced Vital Capacity (FVC) - Percent Predicted
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 (%).
Measured: Screening Visit, Day 7, Day 14, Day 28, Day 42
Change from Baseline in FEV1/FVC Ratio
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.
Measured: Screening Visit, Day 7, Day 14, Day 28, Day 42
Change from Baseline in Peak Expiratory Flow (PEF) - Absolute Value
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).
Measured: Screening Visit, Day 7, Day 14, Day 28, Day 42
Change from Baseline in Peak Expiratory Flow (PEF) - Percent Predicted
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 (%).
Measured: Screening Visit, Day 7, Day 14, Day 28, Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start1 May 2026
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinovirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Altesa Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610395
- Sponsor's protocol ID
- ALT-VPV-203
- Acronym
- Cardinal COPD
- Status last verified
- Oct 2026
- First submitted
- 12 May 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No