Ensifentrine for COPD
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate how well a new treatment, ensifentrine, alleviates symptoms of COPD, a lung disease that makes breathing difficult. Participants will inhale this treatment using a nebulizer twice daily for 12 weeks while continuing their current COPD medication. It targets individuals with moderate to severe COPD who have smoked cigarettes for at least 10 years and experience symptoms like frequent shortness of breath. As a Phase 3 trial, this study is the final step before FDA approval, giving participants the opportunity to contribute to the potential availability of a new COPD treatment.
Do I have to stop taking my current medications for the trial?
No, you can continue taking your current maintenance medications during the trial.
Is there any evidence suggesting that ensifentrine is likely to be safe for humans?
Research shows that ensifentrine is generally well-tolerated by people with chronic obstructive pulmonary disease (COPD). Studies indicate it improves lung function and quality of life with only minor side effects, meaning most people experience no serious problems when using it. Ensifentrine is also approved for regular COPD treatment, suggesting it's safe for ongoing use in managing this condition. While every treatment can have side effects, evidence so far suggests that ensifentrine is a safe option for most patients.12345
Why do researchers think this study treatment might be promising for COPD?
Ensifentrine is unique because it combines two mechanisms of action that set it apart from current COPD treatments. Most treatments for COPD involve bronchodilators like LAMAs and LABAs, which help open airways, or corticosteroids to reduce inflammation. However, ensifentrine acts both as a bronchodilator and an anti-inflammatory agent. Researchers are excited because it enhances lung function more effectively by delivering these dual benefits through a single inhaled medication, potentially offering improved symptom relief and convenience for patients.
What evidence suggests that ensifentrine might be an effective treatment for COPD?
Research shows that ensifentrine, which participants in this trial will receive, can greatly improve lung function for people with COPD (Chronic Obstructive Pulmonary Disease). Studies have found it boosts lung performance and quality of life with few side effects. In trials, patients noticed symptom improvement from the beginning up to about six weeks, with benefits continuing afterward. A combined analysis of earlier trials confirmed significant improvements in lung function. These findings suggest that ensifentrine could be a helpful addition to standard COPD treatments.13567
Are You a Good Fit for This Trial?
This trial is for adults with moderate to severe COPD who are current or former smokers with a significant smoking history. They must have specific lung function scores, experience breathlessness, and be on stable COPD medication. Participants need to be able to use a nebulizer and perform breathing tests.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive twice daily nebulized ensifentrine (3 mg) for 12 weeks in addition to their standard COPD therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ensifentrine
Ensifentrine is already approved in United States for the following indications:
- Chronic obstructive pulmonary disease (COPD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Verona Pharma plc
Lead Sponsor
Midwest Chest Consultants
Collaborator
Midwest Chest Consultants
Collaborator