Status:
COMPLETED
A Study of RPL554 Drug Administered by Metered Dose Inhaler to Treat Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Verona Pharma plc
Collaborating Sponsors:
Iqvia Pty Ltd
Conditions:
COPD
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate 5 doses of RPL554 and placebo, administered by pressurized metered dose inhaler (pMDI), in patients with moderate to severe chronic obstructive pulmonary di...
Detailed Description
The study will consist of two parts. Part A is a parallel group, placebo-controlled single dose study to ascertain the Pharmacokinetics (PK) profile, safety and bronchodilator effect of a single dose ...
Eligibility Criteria
Inclusion
- Male and female patients with moderate to severe COPD, with a post bronchodilator FEV1 of 40 to 80% of predicted and FEV1/FVC ratio of ≤0.70.
- They must have a baseline increase in FEV1 of \>150 mL following four puffs of salbutamol.
- They must have at least a 10 pack-year smoking history, and may be either a current or former smoker.
Exclusion
- Patients must be clinically stable without recent COPD exacerbations or hospitalisations.
- They must not have uncontrolled disease or chronic heart failure.
Key Trial Info
Start Date :
April 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04091360
Start Date
April 29 2019
End Date
January 21 2021
Last Update
September 21 2022
Active Locations (2)
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1
Respiratory Clinical Trials Ltd
London, United Kingdom, W1G 8HU
2
Medicines Evaluation Unit Limited
Wythenshawe, United Kingdom, M23 9QZ