NCT04091360

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 disease (COPD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 16, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2021

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 25, 2022

Completed
Last Updated

September 21, 2022

Status Verified

August 1, 2022

Enrollment Period

1.6 years

First QC Date

June 20, 2019

Results QC Date

January 18, 2022

Last Update Submit

August 29, 2022

Conditions

COPD

Keywords

COPDAdultsPhase IIRPL554Ensifentrine

Outcome Measures

Primary Outcomes (5)

  • Part A: Pharmacokinetic Parameter AUC0-12

    Area under the curve from 0 to 12 hours after single dose drug administration.

    Day 1

  • Part A: Pharmacokinetic Parameter Cmax

    Pharmacokinetic Parameter Cmax after a Single Dose

    Day 1

  • Part A: Pharmacokinetic Parameter AUC0-t

    Area under the curve at maximum concentration 0-24 hrs after single dose drug administration

    Day 1

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

    RPL554 Plasma Pharmacokinetics concentration after single dose

    Day 1

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

    Change from Baseline FEV1 to Peak FEV1 (over 4 hours) after morning dosing on Day 7

    Day 7

Secondary Outcomes (24)

  • Part A: Change From Baseline in Peak FEV1 (Over 4 Hours) After 1 Dose

    Day 1

  • Part A: Change From Baseline in Average FEV1 (Over 4 Hours) After 1 Dose

    Day 1

  • Part A: Change From Baseline in Average FEV1 (Over 12 Hours) After 1 Dose

    Day 1

  • Part A: Safety and Tolerability / Hematology Safety Assessments

    1 day

  • Part A: Safety and Tolerability / Blood Chemistry Safety Assessments: Number of Patients With Treatment-emergent Blood Chemistry Abnormal Laboratory Assessments

    1 day

  • +19 more secondary outcomes

Study Arms (6)

RPL554 100 mcg

EXPERIMENTAL

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

Drug: Part A: RPL554Drug: Placebos

RPL554 300 mcg

EXPERIMENTAL

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.

Drug: Part A: RPL554Drug: PlacebosDrug: Part B: RPL554

RPL554 1000 mcg

EXPERIMENTAL

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.

Drug: Part A: RPL554Drug: PlacebosDrug: Part B: RPL554

RPL554 3000 mcg

EXPERIMENTAL

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.

Drug: Part A: RPL554Drug: PlacebosDrug: Part B: RPL554

RPL554 6000 mcg

EXPERIMENTAL

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

Drug: Part A: RPL554Drug: Placebos

RPL554 Placebo

PLACEBO COMPARATOR

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.

Drug: Part A: RPL554Drug: Placebos

Interventions

Part A: RPL554DRUG

Single dose RPL554 via metered dose inhaler.

Also known as: Part A
RPL554 100 mcgRPL554 1000 mcgRPL554 300 mcgRPL554 3000 mcgRPL554 6000 mcgRPL554 Placebo
PlacebosDRUG

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 100 mcgRPL554 1000 mcgRPL554 300 mcgRPL554 3000 mcgRPL554 6000 mcgRPL554 Placebo
Part B: RPL554DRUG

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

Also known as: Part B
RPL554 1000 mcgRPL554 300 mcgRPL554 3000 mcg

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Respiratory Clinical Trials Ltd

London, W1G 8HU, United Kingdom

Location

Medicines Evaluation Unit Limited

Wythenshawe, M23 9QZ, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Medicare Part B

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MedicareMedical AssistancePublic AssistanceFinancing, GovernmentFinancing, OrganizedEconomicsHealth Care Economics and OrganizationsInsurance, HealthInsuranceLegislation as TopicSocial Control, Formal

Results Point of Contact

Title
Medical Science Director
Organization
Verona Pharma
margot.macdonald-berko@veronapharma.com
6464130307

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blind
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2019

First Posted

September 16, 2019

Study Start

April 29, 2019

Primary Completion

December 10, 2020

Study Completion

January 21, 2021

Last Updated

September 21, 2022

Results First Posted

July 25, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)