Clinical trial

A Phase II, Randomised Study to Assess the Pharmacokinetics, Safety and Pharmacodynamics of Single and Repeat Doses of RPL554 Administered by Pressurised Metered Dose Inhaler in Patients With COPD

Name

RPL554-MD-201

Description

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 disease (COPD).

Trial arms

Trial start

2019-04-29

Estimated PCD

2020-12-10

Trial end

2021-01-21

Status

Completed

Phase

Early phase I

Treatment

Part A: RPL554

Single dose RPL554 via metered dose inhaler.

Arms:

RPL554 100 mcg, RPL554 1000 mcg, RPL554 300 mcg, RPL554 3000 mcg, RPL554 6000 mcg, RPL554 Placebo

Other names:

Part A

Placebos

Part A: Single dose placebo via metered dose inhaler. Part B: Repeat doses of placebo via metered dose inhaler in crossover fashion. One dose administered twice daily over 7 days.

Arms:

RPL554 100 mcg, RPL554 1000 mcg, RPL554 300 mcg, RPL554 3000 mcg, RPL554 6000 mcg, RPL554 Placebo

Part B: RPL554

Part B: Repeat doses via metered dose inhaler in crossover fashion. One dose administered twice daily over 7 days.

Arms:

RPL554 1000 mcg, RPL554 300 mcg, RPL554 3000 mcg

Other names:

Part B

Size

Primary endpoint

Part A: Pharmacokinetic Parameter AUC0-12

Day 1

Part A: Pharmacokinetic Parameter Cmax

Day 1

Part A: Pharmacokinetic Parameter AUC0-t

Day 1

Part A: RPL554 Plasma Pharmacokinetic Parameter (Half-life)

Day 1

Part B: Change From Baseline in Peak FEV1 (Over 4 Hours) on Day 7

Day 7

Eligibility criteria

Inclusion Criteria: * 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 Criteria: * Patients must be clinically stable without recent COPD exacerbations or hospitalisations. * They must not have uncontrolled disease or chronic heart failure.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Double blind', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}

Updated at

2022-09-21

1 organization

2 products

1 indication

Product

RPL554

Indication

Chronic Obstructive Pulmonary Disease

Organization

Verona Pharma

Product

Placebos