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New inhaled drug hopes to clear lungs in mucus diseases

NCT ID NCT06603246

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 6 times

Summary

This early-stage study tests an inhaled drug called GDC-6988 in people with lung conditions that cause thick mucus, like non-CF bronchiectasis and COPD. The main goal is to check if the drug is safe and tolerable. About 128 adults with stable disease and good lung function will take part.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 128 people

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

Started

Nov 2024

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

18 years and older

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: * Percent predicted FEV1 ≥ 40% by spirometry during screening * Ability to demonstrate correct use of the smart DPI at screening, in the investigator's judgment * On a stable treatment regimen for muco-obstructive diseases for ≥ 28 days prior to initiation of study treatment and willingness to remain on the stable treatment regimen through completion of study * Stable disease for ≥ 28 days prior to screening and through to initiation of study treatment Additional Inclusion Criteria for Participants in Part B * Chronic sputum production of ≥1 teaspoon per day as reported in the sputum volume item * Ability to produce a sputum sample that is suitable for central laboratory determination of mucus percent solids and sialic acid concentration exploratory biomarker research, and biomarker assay development * Availability of a representative blood sample for exploratory biomarker research and biomarker assay development Additional Inclusion Criteria for Participants With Non-cystic Fibrosis Bronchiectasis (NCFB) (Cohort 1, Cohort 2, and Cohort 3): \- Diagnosis of bronchiectasis on the basis of prior chest computed tomography (CT), involving at least 2 lobes, with at least one lobe of involvement in the right lung as assessed by the investigator Additional Inclusion Criteria for Participants With Chronic Obstructive Pulmonary Disease (COPD) (Cohort 1, Cohort 2, and Cohort 4): * COPD defined as post-bronchodilator FEV1/FVC ratio of \<0.7 * Chronic bronchitis, with a definition including chronic cough and excessive sputum production for more than 3 months per year for at least 2 years prior to screening * Former smoker with a minimum of 10 pack-year history (e.g., 20 cigarettes/day for 10 years) or non-smoker with at least one documented COPD risk factor Exclusion Criteria: * Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the timeframe in which contraception is required * Known significant bronchodilator response of \>10% predicted change in FEV1 or FVC, in the investigator's judgment * Use of any prohibited medications * Acute respiratory infection within 28 days of screening * Significant hemoptysis greater than 60 milliliter (mL) within 3 months prior to screening * Known immunodeficiency that, in the investigator's judgment, is clinically significant and places the individual at a substantially elevated risk for opportunistic infections. * Known substance abuse, in the investigator's judgment, within 12 months prior to screening * Poor peripheral venous access * Receipt of blood products within 120 days prior to screening * Any medical condition or abnormal clinical laboratory finding that, in the investigator's judgment, would preclude the individual's safe participation in and completion of the study or could affect the interpretation of the results * History of thoracic or metastatic malignancy within 5 years prior to screening * Known history of a clinically significant abnormal electrocardiogram (ECG), or presence of an abnormal ECG that is deemed clinically significant by the investigator * QT interval corrected through use of Fridericia's formula (QTcF) \>450 milliseconds (ms) for males or \>470 ms for females Additional Exclusion Criteria for Participants in Part B -More than 2 chest CTs or other procedures known to expose the lungs to greater than 100 millisievert (mSv) within 12 months prior to screening Additional Exclusion Criteria for Participants With NCFB (Cohort 1, Cohort 2, and Cohort 3) * Bronchiectasis primarily due to cystic fibrosis, primary ciliary dyskinesia, non-tuberculous mycobacterial infection, chronic aspiration, or predominantly traction bronchiectasis due to interstitial lung disease (ILD), in the investigator's judgment * Diagnosis of asthma, that in the investigator's judgment, is the primary driver of the individual's respiratory disease (e.g., primary asthma with incidental bronchiectasis findings) * NCFB exacerbation within 28 days prior to screening or that has not returned to baseline * Current smoker: Current smoking is defined as any use of inhaled tobacco products or inhaled marijuana within 3 months prior to screening, through use of cigarettes, cigars, electronic cigarettes, vaporizing devices, or pipes. Additional Exclusion Criteria for Participants with NCFB in Cohort 3 \- Diagnosis of COPD that, in the investigator's judgment, is the primary driver of the individual's respiratory disease (e.g., primary COPD with incidental bronchiectasis findings) Additional Exclusion Criteria for Participants With COPD (Cohort 1, Cohort 2, and Cohort 4): * COPD exacerbation within 28 days prior to screening or that has not returned to baseline * Asthma/COPD overlap syndrome

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    5 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

  • Accel Research Site - Achieve - Birmingham - ERN - PPDS

    WITHDRAWN

    Vestavia Hills, Alabama, 35216-1927, United States

  • Stanford Center for Excellence in Pulmonary Biology

    RECRUITING

    Palo Alto, California, 94304, United States

  • TTS Research

    COMPLETED

    Boerne, Texas, 78006, United States

  • UPMC Montefiore Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15213 3236, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Kansas Medical Center-Kansas City-3901 Rainbow Blvd

    RECRUITING

    Kansas City, Kansas, 66160 8500, United States

  • University of North Carolina Clinical Research Center

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

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