Study Evaluating 5 Doses of RPL554 and Placebo in COPD Patients Via a Dry Powder Inhaler
NCT04027439 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37
Last updated 2022-09-26
Summary
The purpose of this study is to investigate 5 doses of RPL554 and placebo, administered by dry powder inhaler (DPI), in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Conditions
- Pulmonary Disease, Chronic Obstructive
Interventions
- DRUG
-
Part A: RPL554
1 dose of either 50mcg/100mcg/1500mcg/3000mcg/6000mcg or placebo via dry powder inhaler
- DRUG
-
Part B: RPL554
Patients will receive 4 or 5 repeat dose treatments in crossover fashion - doses will be confirmed after Part A
- DRUG
-
Placebos
Part A: 1 dose of either 50ncg/100ncg/1500ncg/3000ncg/6000ncg or placebo via dry powder inhaler. Part B: Patients will receive 4 or 5 repeat dose treatments in crossover fashion - doses will be confirmed after Part A.
Sponsors & Collaborators
-
Iqvia Pty Ltd
collaborator INDUSTRY -
Verona Pharma plc
lead INDUSTRY
Principal Investigators
-
J Boscia, MD · Vitalink Research
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-12-10
- Primary Completion
- 2019-05-23
- Completion
- 2019-05-23
- FDA Drug
- Yes
Countries
- United States
Study Locations
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