What the trial was testing
The trial enrolled 343 patients with copd. The study was sponsored by Sanofi and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was initial testing (phase 2). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
Former smokers on the injection had 42% fewer COPD flare-ups than those on placebo.
The Lancet. Respiratory medicine · 2021 · NCT03546907
These findings — that former smokers with COPD had fewer breathing attacks on the injection — were published in the The Lancet. Respiratory medicine and represent the headline result of the study.
Researchers tracked outcomes across 343 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with copd, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
If you have COPD and you've already quit smoking, this treatment showed real promise — reducing flare-ups and improving breathing. It didn't work for people still smoking. This was a mid-stage study, so the injection isn't FDA-approved yet. Two larger trials are underway in former smokers. Talk to your doctor about whether you might qualify for one of these trials or ask about other options to reduce flare-ups.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open copd trials
Mapping and Characterization of Alveolar Cells During Smoking and Chronic Obstructive Disease
To evaluate the regenerative capacities of mesenchymal cells composing the microenvironment of alveolar type 2 cells in a population of patients, undergoing thoracic surgery for suspected cancer, who are smokers with and without COPD compared to non-smokers patients
Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease
Chronic obstructive pulmonary disease (COPD) is a chronic lung disease affecting approximately 10% of the adult population globally. COPD is recognised to be an important area of focus, as part of one of the healthcare challenges defined by the Office of Life Sciences. Patients with COPD often experience exacerbations which are triggered episodes leading to disease worsening. Exacerbations are associated with increased morbidity and a risk of mortality. Severe exacerbations, where patients are hospitalised, are of particular concern to patients, carers and healthcare givers. The National Institute for Health and Care Excellence (NICE) recommends that hospital clinicians looking after patients with COPD should provide rescue packs (a course of prednisolone and antibiotics) and a basic management plan to patients on discharge. It is recognised that there is a high-risk 90-day period to patients with COPD following discharge from hospital, where there is a 43% risk of readmission and a 12% risk of mortality; however repeated national audit data has shown that, despite NICE recommendations this high risk of readmission and mortality has not changed. A multicentre randomised clinical trial of 1400 patients will be conducted in 30 acute NHS trusts. This will test the hypothesis that a self-supported rescue pack management plan consisting of rescue packs + written self-management plan + twice weekly telephone/text symptom alert assessments in the high-risk 90-day period is better than standard care in reducing 90-day readmission by 20%. If successful, this intervention would be rapidly implementable, improve patient clinical outcomes and have a cost saving of approximately £350 million per annum.