Ensifentrine + Glycopyrrolate for COPD
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial evaluates the safety and effectiveness of a combination of two medications, ensifentrine and glycopyrrolate, for individuals with COPD, a lung disease that makes breathing difficult. Participants will receive either the combination, one of the medications, or a placebo (a treatment with no active drug). The trial targets those with a history of heavy smoking and ongoing breathing issues due to COPD. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant medical advancements.
Do I need to stop my current medications for the trial?
You can continue taking your current long-acting β2-agonist (LABA) or LABA/inhaled corticosteroid (ICS) medications if you have been using them regularly for at least 60 days before the trial. However, you must be able to pause these medications for a short time before certain tests during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that ensifentrine is generally safe for people with COPD. Previous studies found it improves lung function and reduces symptoms without causing major side effects. The FDA has approved ensifentrine for treating COPD, indicating its safety.
For the combination of ensifentrine and glycopyrrolate, studies are ongoing. Early results suggest this combination is well-tolerated, with patients reporting better lung capacity and fewer COPD symptoms. No significant negative effects have been linked to this treatment.
The trial also tests different doses of glycopyrrolate. While specific safety data for these doses aren't available yet, glycopyrrolate is a commonly used drug and is generally considered safe. Most reported side effects are mild and manageable.
Overall, both treatments have a good safety record, making them promising options for those considering joining the trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for COPD because they combine Ensifentrine with Glycopyrrolate, offering a potentially more effective approach. Ensifentrine is unique because it works as both a bronchodilator and anti-inflammatory, which is different from many existing treatments. By combining it with Glycopyrrolate, a long-acting muscarinic antagonist, there is potential for improved lung function and symptom relief. This dual-action mechanism could offer a new, powerful option for managing COPD symptoms, setting it apart from standard treatments like long-acting beta-agonists or inhaled corticosteroids.
What evidence suggests that this trial's treatments could be effective for COPD?
Studies have shown that ensifentrine improves lung function and reduces symptoms in people with COPD, while also decreasing the number of flare-ups. This treatment eases breathing, potentially enhancing quality of life. In this trial, some participants will receive a combination of ensifentrine with glycopyrrolate. Research suggests this combination might offer extra benefits because they work differently to aid breathing. Other participants will receive glycopyrrolate alone, which relaxes the airways, making breathing easier. Overall, using these two treatments together might effectively manage COPD symptoms.12356
Are You a Good Fit for This Trial?
Adults with COPD, as defined by ATS/ERS guidelines, who experience breathlessness (mMRC Dyspnea Scale ≥2), have a certain lung function level (FEV1/FVC <0.70 and FEV1 between 30-70% of predicted normal), and are current or former smokers with a significant smoking history (≥10 pack years). They must be on stable COPD medication if any, agree to contraception rules, and not have other significant chest x-ray abnormalities.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a fixed dose combination of ensifentrine and glycopyrrolate, monotherapy, or placebo, administered twice a day via oral inhalation by a standard jet nebulizer
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ensifentrine
- Glycopyrrolate
Find a Clinic Near You
Who Is Running the Clinical Trial?
Verona Pharma plc
Lead Sponsor