New pill aims to shorten COPD Flare-Ups from common cold

NCT ID NCT07610395

Symptom relief Sponsor: Altesa Biosciences, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 4 times

Summary

This study tests an oral drug called vapendavir in 180 adults with COPD who catch a rhinovirus (common cold). The goal is to see if it can reduce the severity and length of breathing symptoms compared to a placebo. Participants are randomly assigned to one of two doses or a placebo, and they report their symptoms daily.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Vapendavir
What this could lead to: If it works, this could point toward a treatment that reduces the severity and duration of cold-related breathing problems in people with COPD.
What could go wrong: This is an early phase 2 trial with only 180 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease common cold

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rhinovirus infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

41 sites in 2 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

310 Clinical Research, LLC
RECRUITING

Inglewood, California, 90301, United States
AMR Clinical - Las Vegas
RECRUITING

Las Vegas, Nevada, 89119, United States
AMR Clinical - Lexington
RECRUITING

Lexington, Kentucky, 40509, United States
AMR Clinical - Tempe
RECRUITING

Tempe, Arizona, 85281, United States
Activian Clinical Research - Tomball
RECRUITING

Tomball, Texas, 77375, United States
Apex Clinical Research
RECRUITING

San Diego, California, 92120, United States
Bioluminux Clinical Research Illinois
RECRUITING

Naperville, Illinois, 60540, United States
Bioluminux Clinical Research Milton Keynes
RECRUITING

Milton Keynes, MK15 0DU, United Kingdom
Bioluminux Clinical Research New Jersey
RECRUITING

Hamilton, New Jersey, 08690, United States
Bioluminux Clinical Research Wolverhampton
RECRUITING

Wolverhampton, WV9 5HB, United Kingdom
Brooklyn Clinical Research
RECRUITING

Brooklyn, New York, 11226, United States
CRC Kings Mountain
RECRUITING

Kings Mountain, North Carolina, 28086, United States
Clinical Research Associates of Central PA, LLC
RECRUITING

DuBois, Pennsylvania, 15801, United States
Clinical Research of Rock Hill
RECRUITING

Rock Hill, South Carolina, 29732, United States
Clinicalysis
RECRUITING

London, RM1 1BH, United Kingdom
Covenant Critical Pulmonary Care
RECRUITING

East Point, Georgia, 30344, United States
Epic Clinical Research, LLC
RECRUITING

Lewisville, Texas, 75057, United States
FutureMeds Glasgow
RECRUITING

Glasgow, G20 7BE, United Kingdom
FutureMeds Liverpool
RECRUITING

Bromborough, CH62 6EE, United Kingdom
FutureMeds London
RECRUITING

London, NW10 2PB, United Kingdom
Guthrie Medical Group, PC
RECRUITING

Sayre, Pennsylvania, 18840, United States
Hometown Urgent Care - Milford
RECRUITING

Milford, Ohio, 45150, United States
Medquest Translational Sciences
RECRUITING

Miami Lakes, Florida, 33016, United States
Metropolitan Clinical Research Center
RECRUITING

Tamarac, Florida, 33321, United States
NewportNativeMD, Inc.
RECRUITING

Newport Beach, California, 92663, United States
Oakland Medical Research
RECRUITING

Troy, Michigan, 48085, United States
Patient First Clinical Trials (PFCTRIALS)
RECRUITING

Lutherville, Maryland, 21093, United States
Preferred Primary Care Physicians - St. Clair
RECRUITING

Pittsburgh, Pennsylvania, 15423, United States
ProMed Innovations Clinical Research
RECRUITING

London, SE6 4LF, United Kingdom
Remington-Davis, Inc.
RECRUITING

Columbus, Ohio, 43215, United States
Synergy Health
RECRUITING

Bradenton, Florida, 34209, United States
Tekton Research
RECRUITING

Edmond, Oklahoma, 73013, United States
VM Clintrials
RECRUITING

Miami Lakes, Florida, 33014, United States
Velocity Clinical Research - Anderson
RECRUITING

Anderson, South Carolina, 29621, United States
Velocity Clinical Research - Binghamton
RECRUITING

Binghamton, New York, 13905, United States
Velocity Clinical Research - Medford
RECRUITING

Medford, Oregon, 97504, United States
Velocity Clinical Research - Mobile
RECRUITING

Mobile, Alabama, 36608, United States
Velocity Clinical Research - Spartanburg
RECRUITING

Spartanburg, South Carolina, 29303, United States
Velocity Clinical Research - Union
RECRUITING

Union, South Carolina, 29379, United States
Velocity Clinical Research - Valparaiso
RECRUITING

Valparaiso, Indiana, 46383, United States
Verexa Health
RECRUITING

Dearborn, Michigan, 48126, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.