Phase 2 study for people with COPD
Recruiting Phase 2
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Research Site | Cairns | QLD | Completed |
| Research Site | Nedlands | WA | Recruiting |
| Research Site | Norwood | SA | Recruiting |
| Research Site | Osborne Park | WA | Recruiting |
| Research Site | South Brisbane | QLD | Recruiting |
| Research Site | Wollongong | NSW | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
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:
* Participant must be ≥40 years of age at the time of signing the informed consent.
* Documented primary diagnosis of COPD for at least 12 months prior to enrolment.
* Pre-BD FEV1/FVC \< 0.7 at Visit 1 and pre- and post-BD FEV1/FVC \< 0.7, and post-BD FEV1 ≥ 25% to \< 80% of predicted normal at Visit 2.
* Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations in the 12 months prior to screening.
* Documented stable regimen of inhaled triple maintenance therapy or inhaled dual maintenance therapy for ≥ 3 months prior to screening.
* CAT score ≥ 10 at Visit 1.
* Current or ex-smokers with a cigarette smoking history of ≥ 10 pack-years.
* Participants who are clinically stable and free from an exacerbation of COPD for 4 weeks prior to Visit 1 and are also exacerbation free for at least 4 weeks (28 days) prior to Visit 3 (randomisation).
* Negative pregnancy test at Visit 1 and Visit 3 for Women Of Child-Bearing Potential (WOCBP).
Exclusion Criteria:
* Clinically important pulmonary disease other than COPD (eg, asthma \[current diagnosis per GINA or other accepted guidelines\], active pulmonary infection, clinically significant bronchiectasis when bronchiectasis is the predominant diagnosis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha-1 antitrypsin deficiency or primary ciliary dyskinesia).
* Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms.
* Any unstable disorder, including, but not limited to, CV, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment.
* Significant left heart failure.
* Unstable angina, acute coronary syndrome/acute myocardial infarction or coronary intervention with percutaneous coronary intervention/coronary artery bypass graft within 6 months of randomisation, uncontrolled arrhythmia, or cardiomyopathy, clinically significant aortic stenosis, or signs of pulmonary oedema or volume overload.
* Pulmonary arterial hypertension, either idiopathic or due to connective tissue or thromboembolic disease.
* History of another underlying condition that predisposes the participant to infections.
* History of ulcerative colitis, Crohn's disease, or microscopic colitis diagnosed by either a gastroenterologist or by histopathology.
* Abnormal laboratory findings.
* Participants with evidence of active liver disease and/or evidence of chronic liver disease.
* Participants with history of HIV infection or who test positive for HIV.
* History of lung volume reduction surgery.
* Current or history of malignancy within 5 years before the screening visit.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 9 September 2026.
- This page last checked by Voxsanity: 11 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.