A Study of RPL554 Drug Administered by Metered Dose Inhaler to Treat Chronic Obstructive Pulmonary Disease

Verona Pharma

Status and phase: Completed; Phase 2

Conditions: COPD

Treatments: Drug: Part B: RPL554; Drug: Part A: RPL554; Drug: Placebos

Study type: Interventional

Funder types: Industry

Identifiers

NCT04091360

RPL554-MD-201

Details and patient eligibility

About

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).

Full 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 of RPL554 administered via pMDI. Five of the 6 treatment arms will be double-blind and one will be single-blind (due to the different number of capsules administered). Part B is a 7-day placebo-controlled, complete block cross-over, repeat dose study to assess the bronchodilator effect of repeat doses of RPL554 delivered via pMDI.

Enrollment: 40 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 6 patient groups, including a placebo group

RPL554 100 mcg

Experimental group

Description:

Part A: Patients receive 1 dose of either RPL554 100mcg via metered dose inhaler. Part B: not applicable

Treatment:

Drug: Placebos

Drug: Part A: RPL554

RPL554 300 mcg

Experimental group

Description:

Part A: Patients receive 1 dose of RPL554 300mcg via metered dose inhaler. Part B: Patients receive repeat doses of RPL554 300mcg via metered dose inhaler in crossover fashion.

Treatment:

Drug: Placebos

Drug: Part B: RPL554

Drug: Part A: RPL554

RPL554 1000 mcg

Experimental group

Description:

Part A: Patients receive 1 dose of RPL554 1000mcg via metered dose inhaler. Part B: Patients receive repeat doses of RPL554 3000mcg via metered dose inhaler in crossover fashion.

Treatment:

Drug: Placebos

Drug: Part B: RPL554

Drug: Part A: RPL554

RPL554 3000 mcg

Experimental group

Description:

Part A: Patients receive 1 dose of either RPL554 3000mcg via metered dose inhaler. Part B: Patients receive repeat doses of RPL554 3000mcg via metered dose inhaler in crossover fashion.

Treatment:

Drug: Placebos

Drug: Part B: RPL554

Drug: Part A: RPL554

RPL554 6000 mcg

Experimental group

Description:

Part A: Patients receive 1 dose of either RPL554 6000mcg via metered dose inhaler. Part B: not applicable

Treatment:

Drug: Placebos

Drug: Part A: RPL554

RPL554 Placebo

Placebo Comparator group

Description:

Part A: Patients receive 1 dose of RPL554 placebo via metered dose inhaler. Part B: Patients receive repeat doses of RPL554 placebo via metered dose inhaler in crossover fashion.

Treatment:

Drug: Placebos

Drug: Part A: RPL554