Effect of Ensifentrine on Sputum Markers of Inflammation in COPD

COPD Clinical Trial

Official title: A Randomized, Double-Blind, Placebo-Controlled, Two-period Cross-over Study of the Effect of Ensifentrine on Sputum Markers of Inflammation in Patients With COPD

Status Recruiting

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled, two-period cross-over study of nebulized ensifentrine (3 mg) or placebo administered BID for two 8-week Treatment Periods. All participants with receive both ensifentrine and placebo during participation. There are 7 in-clinic visits over a total duration of up to 24 weeks participation.

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled, two-period cross-over study of nebulized ensifentrine (3 mg) or placebo administered BID for two 8-week Treatment Periods. All participants with receive both ensifentrine and placebo during participation. No more than 50% former smokers will be enrolled.

Participants will be randomized 1:1 to receive ensifentrine or placebo first in Treatment Period 1 followed by the opposite treatment in Treatment Period 2:

1. Treatment Period 1: Ensifentrine; Treatment Period 2: Placebo.

2. Treatment Period 1: Placebo; Treatment Period 2: Ensifentrine.

All participants will take study supplied albuterol (to use as-needed) as well as a once daily COPD Maintenance Therapy during study participation.

The total duration of study participation is 22-24 weeks:

• Screening and Run-in Period: 2-4 weeks; participants will be screened for eligibility before entering a run-in period to ensure a stable background on a once daily COPD Maintenance Therapy.

• Treatment Period 1: 8 weeks; participants completing the Run-in Period and meeting all entry and Randomization Criteria will be randomized to 8 weeks of treatment with blinded, nebulized ensifentrine or placebo + once daily COPD Maintenance Therapy.

• Washout Period: 4 weeks; patients will only take once daily COPD Maintenance Therapy. There will be a follow-up phone call about 1 week after finishing Treatment Period 1.

• Treatment Period 2: 8 weeks of treatment with Study Medication (opposite of Treatment Period 1) + once daily COPD Maintenance Therapy.

• Safety follow-up: 1 week after Treatment Period 2

There are 7 scheduled in-clinic visits: Screening visit + three visits within each treatment period. There is an end of treatment safety telephone follow-up call about 1 week after each treatment period. Participants will have telephone reminders between in-clinic visits. ;

Related Conditions & MeSH terms

• COPD
• Inflammation

• NCT number: NCT05270525
• Study type: Interventional
• Source: Verona Pharma plc
• Status: Recruiting
• Phase: Phase 2
• Start date: May 27, 2022
• Completion date: December 2024