Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Toll Free Number
CONTACT
Lead
Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
With
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. 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.
Age
40–80
Sex
ALL
Healthy volunteers
Not accepted
