Phase 3 COPD Trial, Recruiting NCT06961214 Sponsor: GlaxoSmithKline Condition: COPD
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Phase 3 COPD Trial, Recruiting

NCT06961214
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged between 40 and 80 years old at the time of signing the consent form
  • People with a higher-than-normal level of a type of white blood cell called eosinophils in their blood
  • People with a confirmed diagnosis of COPD (a chronic lung condition) for at least 1 year, based on recognised medical guidelines
  • People whose breathing test results show a specific pattern consistent with moderate to severe COPD (confirm with trial site for exact values)
  • People who have had at least 2 moderate flare-ups, or at least 1 severe flare-up, of their COPD in the 12 months before screening
  • People with a COPD symptom questionnaire score of 10 or higher at the first visit (confirm with trial site)
  • People who are current or former smokers with a smoking history of at least 10 pack-years (a measure combining how much and how long someone smoked)
  • People who have been using a combination of three types of inhaled medications — a steroid inhaler, plus two types of long-acting airway-opening inhalers — for at least 6 months before screening
  • People with a body mass index (a measure of weight relative to height) of 16 or above
  • Male participants and female participants who meet the trial's eligibility conditions

Who may not be able to join:

  • People who have been diagnosed with asthma by a doctor at any point
  • People whose primary lung condition is something other than COPD, as assessed by the investigating doctor
  • People who have had pneumonia, a COPD flare-up, or a lower respiratory tract infection in the 4 weeks before screening
  • People who have had lung volume reduction surgery or an endobronchial valve procedure, or who are planning to have either
  • People who are currently in the active phase of a pulmonary rehabilitation program within 4 weeks before screening
  • People who need supplemental oxygen for more than 12 hours per day
  • People with a heart condition caused by lung disease that has led to right-sided heart failure or severely high blood pressure in the lungs
  • People with a build-up of carbon dioxide in the blood that requires ongoing use of a breathing support machine (such as BiPAP or CPAP)
  • People with unstable heart disease or an irregular heart rhythm
  • People with a known parasitic infection within 6 months before screening

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: GSK Clinical Trials, GlaxoSmithKline

Phone: 877-379-3718

Australian sites

GSK Investigational Site, Coffs Harbour, New South Wales
877-379-3718
GSK Investigational Site, Maroubra, New South Wales
877-379-3718
GSK Investigational Site, Westmead, New South Wales
877-379-3718
GSK Investigational Site, Midland, Western Australia
877-379-3718

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
23 June 2025
Est. completion
21 August 2029

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇬 Bulgaria 🇨🇿 Czechia 🇩🇪 Germany 🇬🇷 Greece 🇮🇱 Israel 🇮🇹 Italy 🇱🇻 Latvia 🇳🇿 New Zealand 🇷🇴 Romania 🇰🇷 South Korea 🇬🇧 United Kingdom 🇺🇸 United States

4 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Annualized Rate of Moderate/Severe Exacerbations

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov