Phase 3 study for people with COPD

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 12 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor GlaxoSmithKline
Registry number NCT06961214
Started 23 June 2025 Today 16 October 2026 Estimated completion 13 December 2028

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
GSK Investigational Site Coffs Harbour NSW Recruiting
GSK Investigational Site Maroubra NSW Recruiting
GSK Investigational Site Westmead NSW Recruiting
GSK Investigational Site Midland WA Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 12 October 2026 · not medical advice

Who can join

Age 40 Years to 80 Years
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 961

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

* Participants must be greater than or equal to (\>=) 40 to less than or equal to (\<=) 80 years of age, at the time of signing the Informed consent

* Elevated Blood Eosinophil Count (BEC)

* Moderate to severe COPD with frequent exacerbations, defined as:

* A clinically documented history of COPD as defined by the American Thoracic Society/European Respiratory Society for at least 1 year

* A post-bronchodilator forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) ratio of \< 0.70 and a post-bronchodilator FEV1 \>30 percent (%) and \<= 80% predicted normal values

* A well-documented history of at least 2 moderate or 1 severe exacerbation in the 12 months prior to screening

* COPD assessment test (CAT) score \>=10 at Visit 1

* Smoking status: Current or former cigarette smokers with a history of cigarette smoking of \>=10 pack-years.

* Participants should be on optimized inhaler therapy, defined as inhaled corticosteroid (ICS) plus Long-acting muscarinic receptor antagonist (LAMA) plus Long-acting beta2-adrenergic receptor agonist (LABA) either as multiple inhalers or a single combination inhaler for at least 6 months prior to Screening Visit 1

* Body mass index (BMI) \>=16 kilogram per square meter (kg/m\^2)

* Male and eligible female participants

Exclusion Criteria:

The following subjects are excluded:

* Participants with a current or prior physician diagnosis of asthma

* Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease

* Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1

* Lung resection: Participants with a history of or plan for lung volume reduction surgery / endobronchial valve procedure.

* Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1

* Continuous oxygen: Participants requiring oxygen supplementation for more than 16 hours per day to maintain resting oxygen saturation greater than 88%

* Cor pulmonale - resulting in right heart failure, severe pulmonary hypertension

* Chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure \[BiPAP\] or Continuous Positive Airway Pressure \[CPAP\])

* Unstable cardiovascular disease or arrhythmia

* Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1)

Dates on the record

Started 23 June 2025
Estimated completion 13 December 2028
Registry last updated 5 October 2026
Checked by Voxsanity 12 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 5 October 2026.
  • This page last checked by Voxsanity: 12 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.