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New oral drug aims to cut dangerous COPD exacerbations

NCT ID NCT07684820

Disease control Sponsor: Expedition Therapeutics, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This Phase 2 study tests whether a once-daily oral tablet called EXPD-101 can reduce the number of moderate to severe COPD flare-ups in people with chronic bronchitis. Participants must have had at least two moderate or one severe exacerbation in the past year. The trial compares two doses of EXPD-101 against a placebo over 52 weeks, monitoring safety and quality of life.

What this could mean

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

Active substance
EXPD-101 (oral tablet)
What this could lead to
If successful, EXPD-101 could become a new daily treatment to reduce the number of serious COPD flare-ups and improve quality of life.
What could go wrong
This is a Phase 2 trial, so the drug is still being tested for safety and effectiveness. It may not work better than placebo, and side effects are possible.

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 600 people

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

Started

Jun 2026

Expected to finish

Jul 2028

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 Criteria: 1. Provided written informed consent for the study 2. Body mass index (BMI) ≥ 18.5 kg/m2 and \< 35 kg/m2 at screening (weight ≥ 50 kg for males and ≥ 45 kg for females) 3. Diagnosis of COPD for at least 1 year 4. COPD with physician-confirmed diagnosis of chronic bronchitis (persistent, productive cough and sputum for at least 3 months in the past year) 5. At least 2 moderate or \> 1 severe exacerbation within 12 months prior to screening 6. Current or ex-tobacco smokers with history of ≥ 10 pack-years (1 pack year = 20 cigarettes smoked per day for 1 year); 7. Stable maintenance therapy with either dual or triple inhaled therapy for ≥ 3 months prior to enrollment per below: 1. Dual therapy: long-acting beta-2 agonist/muscarinic antagonist (LABA/LAMA) or inhaled corticosteroids (ICS)/LAMA, or ICS/LABA OR 2. Triple therapy: ICS/LAMA/LABA 8. Post-BD FEV1/FVC \< 0.7 and post-BD FEV1(% predicted) ≥ 40% at Screening 9. COPD Assessment Test (CAT) score ≥ 10 at Screening 10. If participant is of childbearing potential, must commit to practicing highly effective methods of birth control and not donating eggs during the study and at least 14 days after the last dose. 11. Male participants commit to the following during the study and for at least 14 days after the last dose: 1. Practice true sexual abstinence (refrain from heterosexual intercourse) 2. Use a condom with any female partner of childbearing potential and ensure that the partner uses a highly effective contraceptive method (eg, IUD/IUS, combined hormonal contraception, progestogen-only contraception, or bilateral tubal occlusion). 3. Be vasectomized (≥ 3 months prior to screening) 4. Refrain from donating sperm during the Treatment Period and for at least 14 days after the last dose of the IP Exclusion Criteria: 1. COPD exacerbation within the 4 weeks prior to randomization. 2. Clinically important pulmonary disease other than COPD (eg, asthma, active lung infection, clinically significant bronchiectasis, pulmonary fibrosis, cystic fibrosis, lung cancer, alpha-1 antitrypsin deficiency, tuberculosis). 3. Significant immunodeficiency and/or positive serological tests for hepatitis B, hepatitis C, or known human immunodeficiency virus (HIV) infection. 4. Pneumonia requiring antibiotics or antiviral medication within 28 days prior to Visit 1. 5. History of clinically significant infection (excluding pneumonia), acute upper or lower respiratory infection, requiring antibiotics or antiviral medication within 14 days prior to Visit 1. 6. Evidence of active liver disease (with or without ongoing treatment) 7. Participants with a QT interval, from the ECG conducted at Screening Visit 1, corrected with Fridericia's formula (QTcF) \> 450 msec (or QTcF \> 480 msec in participants with bundle branch block). 8. Current or history, within the past year of Visit 1, of substance and/or alcohol abuse. 9. History of cancer except: 1. Participants who have had basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to Visit 1 2. Participants who have had other malignancies are eligible provided that curative therapy was completed at least 5 years prior to Visit 1 10. Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during Screening Period, which in the opinion of the investigator, may put the participant at risk because of his/her participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study. 11. Known history of allergy or reaction to any component of the investigational product formulation 12. Current treatment with biologic drugs for COPD (eg, dupilumab, mepolizumab) or use of Therapeutics, biologics within 5 half-lives or 4 months, whichever is longer, from randomization 13. Current long-term treatment with oxygen therapy \> 12 hours per day 14. Use of immunoglobulin or blood products in 30 days prior to Screening 15. Received a live attenuated vaccine within 30 days prior to Screening 16. Participants who are participating in the acute phase of a pulmonary rehabilitation program, i.e. who started rehabilitation \< 4 weeks prior to screening (Note: participants in the maintenance phase of a rehabilitation program can be included). 17. History or active conditions associated with the onset of non-hereditary palmoplantar keratosis: 18. Have any tooth that can potentially cause pain or infection as noted in the oral exam unless they are corrected before the study 19. Has active periodontal disease and are either: 1. Currently treated by a dentist for this condition or 2. Expected to have periodontal disease-related procedures within the study period 20. Are scheduled to have tooth extraction that will occur during the study period

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Conditions

The condition(s) this trial relates to.

bronchitis chronic obstructive pulmonary disease

As listed by the trial registrant

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

Chronic obstructive pulmonary disease (COPD)

How to take part

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

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • Burke Internal Medicine, Inc.

    RECRUITING

    Burke, Virginia, 22015, United States

  • California Medical Research Associates Inc.

    RECRUITING

    Northridge, California, 91324, United States

  • Carolina Research Center, Inc.

    RECRUITING

    Shelby, North Carolina, 28150, United States

  • Centricity Research Columbus

    NOT_YET_RECRUITING

    Rincon, Georgia, 31326, United States

  • Clinical Research Associates of Central PA, LLC

    RECRUITING

    DuBois, Pennsylvania, 15801, United States

  • Clinical Site Partners, LLC Leesburg dba Flourish Research

    RECRUITING

    Leesburg, Florida, 34748, United States

  • Cotton O'Neil Clinical Research Center

    RECRUITING

    Topeka, Kansas, 66606, United States

  • DM Clinical Research - Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • DM Clinical Research - Phoenix

    RECRUITING

    Phoenix, Arizona, 85012, United States

  • DM Clinical Research- Tomball

    RECRUITING

    Tomball, Texas, 77375, United States

  • DM Clinical Research-Indianapolis

    RECRUITING

    Indianapolis, Indiana, 46254, United States

  • Headlands Research Twin Cities

    RECRUITING

    Maplewood, Minnesota, 55109, United States

  • Horizon Clinical Research Group.

    RECRUITING

    Cypress, Texas, 77429, United States

  • International Clinical Research

    RECRUITING

    Altamonte Springs, Florida, 32701, United States

  • Lynn Institute of Denver

    RECRUITING

    Aurora, Colorado, 80012, United States

  • Nature Coast Clinical Research

    RECRUITING

    Crystal River, Florida, 34229, United States

  • Optimal Research Sites

    RECRUITING

    Orange, Florida, 32763, United States

  • Remington-Davis Research

    RECRUITING

    Columbus, Ohio, 43215, United States

  • Suncoast Research Group, LLC Miami - Little Havana dba Flourish Research

    RECRUITING

    Miami, Florida, 33135, United States

  • Tidewater Clinical Research

    RECRUITING

    Virginia Beach, Virginia, 23456, United States

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