Ensifentrine for COPD

Recruiting at 1 trial location

Overseen By Krista Mueller

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Verona Pharma plc

Must be taking: LAMA/LABA, LAMA/LABA/ICS

Must not be taking: Nebulized medication

Disqualifiers: Asthma, Lung cancer, Unstable cardiac, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this open-label, single center trial is to assess the effect of twice daily nebulized ensifentrine (3 mg) on COPD symptoms measured by the COPD Assessment Test (CAT™) scores over 12 weeks in subjects with symptomatic, moderate to severe COPD, taking maintenance LAMA/LABA or LAMA/LABA/ICS therapy. Subjects will continue the maintenance treatment during study participation.

Eligibility Criteria

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

My COPD score is 10 or higher.

Pre- and post-albuterol FEV1/FVC ratio of < 0.70

I have a history of moderate to severe COPD.

Exclusion Criteria

My lung therapy has been stable for at least 4 weeks.

I have not had a lung infection or any active infection in the last 6 weeks.

I have a lung condition other than COPD that affects my health significantly.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive twice daily nebulized ensifentrine (3 mg) for 12 weeks in addition to their standard COPD therapy

12 weeks

Visits at baseline, week 6, and week 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Ensifentrine

Trial Overview The study is testing the effects of Ensifentrine 3mg when inhaled twice daily over 12 weeks on COPD symptoms. It's an open-label trial where everyone knows they're getting Ensifentrine while continuing their usual COPD treatments.

Participant Groups

Group I: Ensifentrine Experimental Treatment 1 Intervention

Inhaled ensifentrine twice daily for 12 weeks via standard jet nebulizer in addition to standard dual (LAMA/LABA) or triple (LAMA/LABA/ICS) COPD therapy.

Ensifentrine is already approved in United States for the following indications:

Approved in United States as Ohtuvayre for:

• Chronic obstructive pulmonary disease (COPD)

Who Is Running the Clinical Trial?

Verona Pharma plc

Lead Sponsor

Trials

16

Recruited

3,000+

Midwest Chest Consultants

Collaborator

Trials

2

Recruited

50+

Midwest Chest Consultants

Collaborator

Trials

2

Recruited

50+