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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-29

Study Completion Date

2021-01-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study Evaluating 5 Doses of RPL554 and Placebo in COPD Patients Via a Dry Powder Inhaler

NCT04027439

Pulmonary Disease, Chronic Obstructive

COMPLETED PHASE2

The Effects of RPL554 on Top of Standard COPD Reliever Medications

NCT02542254

Chronic Obstructive Pulmonary Disease

COMPLETED PHASE2

Dose Ranging Study of RPL554 in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT03443414

COPD

COMPLETED PHASE2

SAD/MAD Study of a New Formulation of Nebulised RPL554 in Healthy Subjects and COPD Subjects

NCT02307162

Inflammatory Disorder of the Respiratory Tract Chronic Obstructive Pulmonary Disorder

COMPLETED PHASE1

The Effects of RPL554 in Addition to Tiotropium in COPD Patients

NCT03028142

Chronic Obstructive Pulmonary Disease Moderate

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Double blind

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RPL554 100 mcg

Part A: Patients receive 1 dose of either RPL554 100mcg via metered dose inhaler.

Part B: not applicable

Group Type EXPERIMENTAL

Part A: RPL554

Intervention Type DRUG

Single dose RPL554 via metered dose inhaler.

Placebos

Intervention Type DRUG

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.

RPL554 300 mcg

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.

Group Type EXPERIMENTAL

Part A: RPL554

Intervention Type DRUG

Single dose RPL554 via metered dose inhaler.

Placebos

Intervention Type DRUG

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.

Part B: RPL554

Intervention Type DRUG

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

RPL554 1000 mcg

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.

Group Type EXPERIMENTAL

Part A: RPL554

Intervention Type DRUG

Single dose RPL554 via metered dose inhaler.

Placebos

Intervention Type DRUG

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.

Part B: RPL554

Intervention Type DRUG

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

RPL554 3000 mcg

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.

Group Type EXPERIMENTAL

Part A: RPL554

Intervention Type DRUG

Single dose RPL554 via metered dose inhaler.

Placebos

Intervention Type DRUG

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.

Part B: RPL554

Intervention Type DRUG

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

RPL554 6000 mcg

Part A: Patients receive 1 dose of either RPL554 6000mcg via metered dose inhaler.

Part B: not applicable

Group Type EXPERIMENTAL

Part A: RPL554

Intervention Type DRUG

Single dose RPL554 via metered dose inhaler.

Placebos

Intervention Type DRUG

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.

RPL554 Placebo

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.

Group Type PLACEBO_COMPARATOR

Part A: RPL554

Intervention Type DRUG

Single dose RPL554 via metered dose inhaler.

Placebos

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Part A: RPL554

Single dose RPL554 via metered dose inhaler.

Intervention Type DRUG

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.

Intervention Type DRUG

Part B: RPL554

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Part A Part B

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No