Study Investigating the Effect of 4 Doses of RPL554 Given in Addition to Tiotropium to Patients With COPD
Condition: COPD
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the dose response of RPL554 in patients with
      moderate to severe CHRONIC OBSTRUCTIVE PULMONARY DISEASE that are still symptomatic despite
      treatment with a stable background of tiotropium over 4 weeks of treatment. This study is
      intended to support optimal dose selection for a Phase III program evaluating RPL554 as an
      add-on treatment to standard of care therapy.
    

Detailed description: 
      This is a Phase IIb, randomized, double-blind, placebo controlled, multiple dose, parallel
      group study to investigate the effects of 4 weeks of treatment with nebulized RPL554 (at
      different dose levels) compared to placebo in patients with moderate to severe CHRONIC
      OBSTRUCTIVE PULMONARY DISEASE on a stable background therapy of open-label tiotropium. The
      study comprises seven visits: Pre-screening (Visit 0), Screening (Visit 1) and then a
      Treatment Period consisting of Randomization (Visit 2), and weekly visits for 4 weeks (Visit
      3 to Visit 6).
    

Intervention name(s): Ensifentrine (formerly RPL554) 0.375 mg twice daily plus placebo, in addition to tiotropium; Ensifentrine (formerly RPL554) 0.75 mg twice daily plus placebo, in addition to tiotropium; Ensifentrine (formerly RPL554) 1.5 mg twice daily plus placebo, in addition to tiotropium; Ensifentrine (formerly RPL554) 3.0 mg twice daily plus placebo, in addition to tiotropium; Ensifentrine (formerly RPL554) placebo twice daily, in addition to tiotropium
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Patients will be randomized to receive one of the following treatment arms plus tiotropiuim:
● RPL554 0.375 mg twice daily The approximate planned duration for each completed patient will be 14 days of run-in and 28 days of treatment with study medication.; Patients will be randomized to receive one of the following treatment arms plus tiotropiuim:
● RPL554 0.75 mg twice daily The approximate planned duration for each completed patient will be 14 days of run-in and 28 days of treatment with study medication.; Patients will be randomized to receive one of the following treatment arms plus tiotropiuim:
● RPL554 1.5 mg twice daily The approximate planned duration for each completed patient will be 14 days of run-in and 28 days of treatment with study medication.; Patients will be randomized to receive one of the following treatment arms plus tiotropiuim:
● RPL554 3.0 mg twice daily The approximate planned duration for each completed patient will be 14 days of run-in and 28 days of treatment with study medication.; Patients will be randomized to receive one of the following treatment arms plus tiotropiuim:
● Placebo twice daily The approximate planned duration for each completed patient will be 14 days of run-in and 28 days of treatment with study medication.
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment