Trial Comparing the Safety and Efficacy of Two Different Oral VPV Doses With Placebo as Treatment for RV in Participants With COPD
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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 40 Years to 85 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests two doses of vapendavir, a medicine taken by mouth, against a placebo, which has no active medicine. It will check safety and whether the medicine makes breathing symptoms from rhinovirus, a cold virus, milder or shorter. It is for adults ages 40–85 with COPD, a long-term lung disease that makes breathing hard.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 40–85 and sign a form agreeing to join the study and release medical records if needed.
- Have confirmed COPD and meet the study’s breathing test limits.
- Have at least one recorded COPD flare-up in the past year that needed more treatment or emergency care. Have a COPD symptom score of at least 10 at screening.
- Be able to follow study steps, use a phone app for daily symptom reports, take nose swabs at home, and notice cold symptoms.
- Spend time with people without a mask at least twice a week, or live in a home with people from different generations.
- If required, agree to use highly effective birth control through 30 days after the last dose for women or 90 days for men. Women cannot use hormonal birth control alone.
- Before assignment to a study group, have no COPD flare-ups or breathing infections for 2 months. Regular COPD treatment, if used, must be stable for 2 months unless an approved change is made.
- At group assignment, test positive for rhinovirus with no other infection. Have at least 3 breathing symptom scores recorded in the past 35 days.
Who can't join
- Be pregnant, breastfeeding, or expected to become pregnant during the study.
- Have a current COPD flare-up or one within 2 months before screening. You may be screened again after it has been resolved for 2 months.
- Have another main cause of long-term blocked airflow, such as asthma alone, cystic fibrosis, or lung scarring. COPD with asthma features is allowed.
- Have a major health problem that is not stable or controlled, important abnormal blood tests, or certain abnormal heart tracing results.
- Have hepatitis B, or hepatitis C that has not been treated and confirmed cleared by testing. People on stable HIV treatment need approval from the study’s medical monitor.
- Take medicines or other products that may have unsafe effects with vapendavir. Also excluded: regular steroid pills or other whole-body steroids over 10 mg daily, or continuous oxygen over 2 liters per minute, except allowed temporary increases. Inhaled steroids are allowed.
- Have taken vapendavir in another trial, or take part in another drug study too close to screening or during this study. Studies that only observe people are allowed.
- At group assignment, be likely to need antibiotics or steroid pills, or have another diagnosed infection needing treatment that is active then or was active within the past 7 days.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (37)
AL
- Velocity Clinical Research - Mobile · Mobile, AL 36608Velocity Clinical Research - Mobile · Study contactMore trials in Mobile
AZ
- AMR Clinical - Tempe · Tempe, AZ 85281AMR Clinical - Tempe · Study contactMore trials in Tempe
CA
- 310 Clinical Research, LLC · Inglewood, CA 90301More trials in Inglewood
- NewportNativeMD, Inc. · Newport Beach, CA 92663NewportNativeMD, Inc. · Study contactMore trials in Newport Beach
- Apex Clinical Research · San Diego, CA 92120Apex Clinical Research · Study contactMore trials in San Diego
FL
- Synergy Health · Bradenton, FL 34209Synergy Health · Study contactMore trials in Bradenton
- VM Clintrials · Miami Lakes, FL 33014VM Clintrials · Study contactMore trials in Miami Lakes
- Medquest Translational Sciences · Miami Lakes, FL 33016Medquest Translational Sciences · Study contactMore trials in Miami Lakes
- Metropolitan Clinical Research Center · Tamarac, FL 33321Metropolitan Clinical Research Center · Study contactMore trials in Tamarac
GA
- Covenant Critical Pulmonary Care · East Point, GA 30344Covenant Critical Pulmonary Care · Study contactMore trials in East Point
- Accelerated Clinical Trials · Snellville, GA 30078More trials in Snellville
IL
- Bioluminux Clinical Research Illinois · Naperville, IL 60540Bioluminux Clinical Research Illinois · Study contactMore trials in Naperville
IN
- Velocity Clinical Research - Valparaiso · Valparaiso, IN 46383Velocity Clinical Research - Valparaiso · Study contactMore trials in Valparaiso
KY
- AMR Clinical - Lexington · Lexington, KY 40509More trials in Lexington
MD
- Patient First Clinical Trials (PFCTRIALS) · Lutherville, MD 21093Patient First Clinical Trials (PFCTRIALS) · Study contactMore trials in Lutherville
MI
- Verexa Health · Dearborn, MI 48126Verexa Health · Study contactMore trials in Dearborn
- Oakland Medical Research · Troy, MI 48085Oakland Medical Research · Study contactMore trials in Troy
NC
- CRC Kings Mountain · Kings Mountain, NC 28086CRC Kings Mountain · Study contactMore trials in Kings Mountain
NJ
- Bioluminux Clinical Research New Jersey · Hamilton, NJ 08690Bioluminux Clinical Research New Jersey · Study contactMore trials in Hamilton
NV
- AMR Clinical - Las Vegas · Las Vegas, NV 89119AMR Clinical - Las Vegas · Study contactMore trials in Las Vegas
NY
- Velocity Clinical Research - Binghamton · Binghamton, NY 13905Velocity Clinical Research - Binghamton · Study contactMore trials in Binghamton
- Brooklyn Clinical Research · Brooklyn, NY 11226Brooklyn Clinical Research · Study contactMore trials in Brooklyn
OH
- Remington-Davis, Inc. · Columbus, OH 43215Remington-Davis, Inc. · Study contactMore trials in Columbus
- Hometown Urgent Care - Milford · Milford, OH 45150Hometown Urgent Care - Milford · Study contactMore trials in Milford
OK
- Tekton Research · Edmond, OK 73013Tekton Research · Study contactMore trials in Edmond
OR
- Velocity Clinical Research - Medford · Medford, OR 97504Velocity Clinical Research - Medford · Study contactMore trials in Medford
PA
- Clinical Research Associates of Central PA, LLC · DuBois, PA 15801Clinical Research Associates of Central PA, LLC l · Study contactMore trials in DuBois
- Preferred Primary Care Physicians - St. Clair · Pittsburgh, PA 15423Preferred Primary Care Physicians - St. Clair · Study contactMore trials in Pittsburgh
- Guthrie Medical Group, PC · Sayre, PA 18840Guthrie Medical Group, PC · Study contactMore trials in Sayre
SC
- Velocity Clinical Research - Anderson · Anderson, SC 29621Velocity Clinical Research - Anderson · Study contactMore trials in Anderson
- Clinical Research of Rock Hill · Rock Hill, SC 29732Clinical Research of Rock Hill · Study contactMore trials in Rock Hill
- Velocity Clinical Research - Spartanburg · Spartanburg, SC 29303Velocity Clinical Research - Spartanburg · Study contactMore trials in Spartanburg
- Velocity Clinical Research - Union · Union, SC 29379Velocity Clinical Research - Union · Study contactMore trials in Union
TX
- Zenos Clinical Research, LLC · Dallas, TX 75230More trials in Dallas
- Activian Clinical Research - Kingwood · Kingwood, TX 77339More trials in Kingwood
- Epic Clinical Research, LLC · Lewisville, TX 75057More trials in Lewisville
- Activian Clinical Research - Tomball · Tomball, TX 77375Activian Clinical Research - Tomball · Study contactMore trials in Tomball